The comment window for a temporary measure that would appoint organizations to test and certify EHR systems has closed, but debate on the final certification program is ongoing.
All of the questions about ONC-authorized testing and certification bodies (ATCB) won't be answered until ONC issues its final rule. But there are hints of what's to come, including who will apply for ATCB status and how much they might charge for the service, as well as some comments that could impact the final rule.
Who will certify?
The Chicago-based Certification Commission for Health Information Technology (CCHIT) came out of the gate early with an announcement that it would apply to become a certifying body. Since then, a few other organizations have stepped up, including the Drummond Group in Austin, TX, and MacPractice in Lincoln, NE.
The ONC hopes to certify up to three organizations, said policy analyst Steve Posnack during a recent HHS Webcast. "We've received early indications that there are at least three entities interested and there could be more," he said. "That's not to say that all of them will actually be qualified at the end of the day, but I think we're seeing a good strong showing of interest that there will be multiple ONC ATCBs."
How will they qualify?
Organizations that want to be ATCBs will submit a request to the national coordinator and indicate the type of authorization sought, such as for complete EHRs and EHR modules, including e-prescribing or clinical decision support modules. They would have to show they understand the certification criteria and standards, that they can properly identify the test tools and methods that are applicable to the certification criteria, and that they can properly use test tools. Once ONC grants ATCB status, it would publish the organization's name and the scope of their authorization.
How much will it cost?
Based on data from CCHIT, certification bodies would likely charge vendors (and ultimately hospitals, since such costs are always passed along to the customer in one form or another) from several thousand dollars to $20,000 for certification of EHR modules to several tens of thousands for complete EHRs.
Theoretically, more organizations in the certification business would mean more competition, which could drive prices down. But for now the government has no plans to regulate prices.
How long will it take?
As potential certifying organizations, vendors, associations, and other groups submit their comments on the proposed rule, one trend has emerged: dissatisfaction with how long it will take to get certification in place.
Although the temporary certification program's 30-day comment period ended April 9, the permanent rule comment period is open until May 10. ONC has said it plans to release the final rule for the temporary certification program at the same time as the final rules for meaningful use stage 1. The permanent certification program is expected to be finalized in the fall.
In its comments to the ONC, The College of Healthcare Information Management Executives (CHIME) says it supports the general concept of moving to a two-stage approach for creating a certification process for electronic health records, but adds significant questions remain.
"It's essential to certify clinical technology quickly yet thoroughly, so that providers can implement applications that will enable them to receive stimulus funds for meaningful use of EHR technology," the organization wrote. "We are very concerned that the introduction of a two-stage approach for certification will prolong the current instability in the health IT marketplace, which exists because of the un-finalized status of meaningful use and certification regulations . . . Above all else, providers need a stable marketplace in which vendors can quickly offer and support implementation of certified products."
Barrington, IL-based GE Healthcare's public comment also urges ONC to speed up the process.
"Time is very short for vendors to make any adjustments to EHR technology to meet certification criteria and processes and then to have certified EHR technology available timely for providers to demonstrate meaningful use during 2011. Software development includes multiple steps to ensure high quality software that is safe for patients. Thus, not only must we have a certification process that can start rapidly with high throughput, it is essential that the final meaningful use and certification criteria are issued as soon as possible and that CMS and ONC not make any changes that would require additional EHR functionality beyond those in the CMS and ONC criteria already released," the vendor wrote in its comments.
The timeline and complexity of the process pose barriers to adoption and innovation, CCHIT said in its public comments. "We believe the criteria and standards need refinement in order to drive an achievable step forward in the meaningful use of EHRs," said Mark Leavitt, MD, PhD, CCHIT chair, adding that the commission is "concerned about the possibility of an unintended deceleration in the pace of EHR adoption."
The American Health Information Management Association (AHIMA) also weighed in on the timeline. "AHIMA understands the urgency in establishing an enhanced national certification program. However, given the startup time and resources needed to launch a certification organization, the very tight time constraints this rule establishes could pose a challenge for entities who wish to become" authorized testing and certification bodies.
Starting to sense a theme here? How ONC will address these concerns is just one of many unanswered questions.
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When you think of innovation in healthcare technology, you probably picture a large academic medical center or a large hospital system. But small and rural hospitals are perfectly capable of making investments in new technologies.
In fact, one might argue that small rural hospitals that adopt new technologies are even more adventurous than the big guys. They have a lot more to lose.
In our HealthLeaders Media Industry Survey 2010, we asked technology leaders to describe their organization's IT culture. Most (43%) answered "wait until proven." But the second most-popular choice was "early adopter," with 37% choosing the response, up from 34% the previous year. (Another 20% said they are "behind the curve.")
One surprising stat—of those who chose the "early adopter response," most (31%) were small hospitals. It wasn't an overwhelming majority—technology leaders from large and mid-sized hospitals chose that response 23% and 24%, respectively. The rest (18%) were critical access hospitals with fewer than 25 beds.
I interviewed Roger Neal, vice president and chief information officer of the 192-bed Duncan (OK) Regional Hospital, about why his organization is among the early adopters of new technologies. Safety and efficiency are the key reasons, he says. For small hospitals, especially, it's a good idea to adopt new technology before your competitors—that way you have time to work with vendors and ensure successful implementation.
"Especially for smaller rural hospitals, being an early adopter puts you ahead of the curve and gives you a little more time to implement a solution correctly with more support from the company. This makes it a safer system for our patients and staff and gives us some efficiency early on with a new technology so we get a jump start in the market," he says.
One main benefit of being an early adopter is the impression on staff, physicians, and the community. The goal is to show them that the organization is working to be cutting-edge but also that it is doing so in a sensible manner. "It shows a commitment to providing the safest and highest quality care we can in a rural setting," he says.
Of course, there are plenty of reasons that not all rural hospitals take this approach.
"Any early adoption program comes with some risk," Neal says. "Will the company be around, will the solution work, what have we not thought of during the implementation? But in the end, we've always found that adopting early on the right projects gives us a much better position and outweighs the struggles we'll experience moving a newer technology forward."
One trend I've noticed is that small, rural, and community hospitals are starting to take more risks. Some technologies previously found only in academic medical centers or large hospitals and systems are migrating into areas that haven't had access to these resources in the past. And that, the healthcare leaders I talk to say, keeps patients and physicians from migrating out of those areas. As markets get more and more competitive—and as technology gets increasingly advanced—being out ahead on technology when practical seems like a smart move.
For more examples of early adopters, check out my May cover story on medical breakthroughs, which describes new technology in use in a variety of settings. Is your organization an early adopter of any size? I'd love to hear your story—you can e-mail me at the address below or connect with me on Twitter.
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Can broadband really save healthcare? Well, technology is part of the solution for some of the industry's problems, such as physician and specialist shortages and disparities in access to care. But it's only part of the solution. And it comes with problems of its own. (Read more about wireless health, telehealth, and more in the March HealthLeaders magazine cover story, Medical Breakthroughs That Will Change Healthcare.)
Here's just one example of how technology solves problems, raises new issues, and leaves still others unresolved. One exclamation point-filled sidebar in the report is titled "Stroke Victim Makes Full Recovery—Thanks to e-Care" and it tells the story of a 49-year-old woman who was connected by video to a specialist at a Boston hospital. The specialist made the right diagnosis, which allowed him to choose the right course of treatment—and the result was a good outcome.
What's wrong with that picture is everything you don't see: How or whether the specialist was compensated for his time, the time and money it took to create video- and data-sharing capabilities between the two hospitals, the fact that hospitals that share data in this manner have to agree upon a compatible platform, and the number of hospitals that aren't spending the time and money on this type of program, just for starters.
The bigger underlying problem is that while telehealth helps alleviate physician shortages, it doesn't solve that problem by a long shot. Telehealth is an excellent tool. But despite what the headline of that sidebar would have you believe, without the caregivers on both sides of the camera, it's worthless.
In the report, the FCC makes several recommendations to start to address some of the barriers to implementing broadband enabled healthcare technology.
Incentives
Physicians and hospitals shoulder most of the cost of e-health technologies while payers and patients benefit. But if the Centers for Medicare & Medicaid Services (CMS) paid providers for using effective health IT solutions, everyone would be happy.
Unfortunately, fee-for-service reimbursement doesn't necessarily work when it comes to health IT—and payment reform is years away. One solution the FCC offers is for Health and Human Services (HHS) to include e-health technologies in future iterations of its meaningful use program, using the same rigor it does to measure meaningful use of EMRs.
The FCC's recommendation: Congress and HHS should develop a strategy that documents the proven value of e-health technologies through pilots and demonstration projects, proposes reimbursement reforms that incent their meaningful use, and charts a path for their widespread adoption.
Interoperability
The report notes that it's hard to collect and aggregate digital health data—an understatement if ever there was one.
Meaningful use incentives will help, pushing providers and vendors toward interoperable solutions. But clinical research will continue to suffer without uniform standards, according to the report. Coordinated standards and protocols will likely increase innovation and discovery within basic science, clinical, and public health research, "helping alleviate many failings of the healthcare system." (I told you they were rosy on the whole technology-will-save-healthcare thing.)
The FCC's recommendation: The Office of the National Coordinator for Health Information Technology (ONC) should establish common standards and protocols for sharing administrative, research and clinical data, and provide incentives for their use.
Adoption
The U.S. is not taking full advantage of health IT opportunities—out of 11 countries, we rank in the bottom half of every adoption metric, according to the report. Despite government incentives, we're at the bottom of the list when it comes to EMRs, electronic prescribing, and electronic clinical note entry—ranking 10th in all three categories. E-health adoption is also low—less than 1% of provider locations use e-health technology.
And we're standing in our own way—rules and regulations just haven't kept pace with technology. The best illustration: The FDA governs medical devices, tools, and applications that rely on wireless communication. But general purpose communications devices such as smart phones fall under the jurisdiction of the FCC. So what about smart phones with decision-support apps? The FCC and the FDA have to work together to sort that out, the report says.
Credentialing and privileging standards are another example. Hospitals cannot grant privileges based on the decision of another hospital. So any physician who would conduct video diagnosis such as the one in the example above would have to be vetted first. It's expensive. And the irony is that hospitals that most need help from remote specialists probably lack the expertise to privilege them. It's also a burden on remote physicians to maintain privileges at a number of organizations. All of this further limiting the pool of experts available to the hospitals that need them.
E-prescribing is also tangled up in red tape, including the ban on e-prescribing controlled substances. The Drug Enforcement Agency (DEA) required doctors to keep two sets of records—paper and fax. "The complexity of dual systems is a best an inconvenience and at worst an impediment to adoption," the report states.
The FCC's recommendation: Congress, states, and CMS should consider reducing regulatory barriers that inhibit adoption of health IT solutions. The FCC and the Food and Drug Administration (FDA) should clarify regulatory requirements and the approval process for converged communications and health care devices.
For a government agency, you have to admit that the FCC's recommendations aren't half bad. But making it all happen is a whole different story. Just take a look at the alphabet soup of government agencies cited in the report. FCC, HHS, CMS, FDA, ONC—even, for goodness' sake, the DEA. Not to mention Congress.
It's going to require a lot of communication, cooperation, and hard work—as well as buy-in from providers and other stakeholders—before broadband and e-health can even come close to saving healthcare.
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Operating rooms are getting a lot more crowded. And the variety of new tools that are cropping up in ORs, from medical communications devices to major moveable medical equipment, will someday be as common and as essential as the operating room table, according to Terry Miller, executive vice president and chief operating officer and William Hinton vice president, of Gene Burton & Associates, a medical technology planning and project management consultancy headquartered in Franklin, TN.
Speaking at the recent Healthcare Information and Management Systems Society (HIMSS) convention in Atlanta, they talked about OR additions, such as interventional cardiac cath lab equipment, interventional vascular suites, and interventional MRIs. "It's an extremely busy room," Hinton said.
Of course, designing the OR of the future comes with plenty of challenges. For starters, the procedure room can exceed 900 square feet—plus a control room that runs about 200 square feet. If you have two ORs that share an interventional MRI that moves between rooms on ceiling tracks, you also need space in between to park the MRI when not in use. Other major considerations include radiation and magnetic shielding and emergency power backup.
There are also workflow issues. Just one example: If you have an MRI in the room, you can't use stainless steel surgical instruments—they must be nonferrous.
"The devil's in the details," Steve Ronstrom, president and CEO of Sacred Heart Hospital in Eau Claire, WI, told me for this month's HealthLeaders magazine cover story, "Medical Breakthroughs That Will Change Healthcare." Sacred Heart's smart OR includes a navigational device that's like GPS for the brain—four 57-inch plasma screens that allow the whole team to see what's going on at any stage of the operation in high-def 3-D, and an intra-operative MRI. Something as simple as the correct positioning of the patients' headrest, he said, can be a big deal.
Then there's the price tag. Although about 60% of hospitals are implementing a smart or hybrid OR, according to Miller and Hinton, the high cost of change is slowing progress.
These complexities—and many more—require a team approach among some groups that haven't always worked well together, such as surgery and imaging. And as OR equipment and systems become more computerized and integrated, sharing a common language and infrastructure, hospitals will have to lean on IT for help. There's a lot of data management from imaging equipment, video integration, and picture archiving, Hinton added.
The benefits, of course, are the additional procedures that can be performed in this new breed of OR and the potential improvement in clinical quality.
Minimally invasive procedures that can be performed in the hybrid OR include cardiac catheterization and peripheral vascular procedures with interventions, such as stent placement and carotid stenting. Surgical procedures include coronary artery bypass grafts, peripheral vascular grafts, and endarterectomies. Navigational tools allow surgeons to make the smallest possible incisions, resulting in faster recovery time and allowing the team to treat sicker, older, and more fragile patients.
The intra-operative MRI allows surgeons to examine a patient while he or she is still in the OR to make sure the entire tumor has been removed, reducing reoperation rates. "It's had a profound impact on patient care," says Kamal Thapar, MD, director of the brain and spine institute and director for tertiary care at Sacred Heart, as well as a neurosurgeon with Marshfield Clinic.
Screw malposition rates are just one example of how the technology is improving outcomes. If medical screws, which are used to stabilize the spine, are not positioned correctly, the results can be fatal, so most patients must undergo a second surgery to fix poor placement. The average screw malposition rate is about 5%. Thapar's freehand screw malposition rate was about 2.5%. After the hospital opened its new OR, the screw malposition rate dropped to less than 0.1%. The re-operating rate went from 15% to 0%. "This was the first time in my entire career I achieved a zero anything," he said.
That's the kind of outcome that has more and more hospitals considering OR upgrades, despite their cost, complex nature, and the intense work—and teamwork—they require.
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Aaron Kowalski is the vice president for glucose control research at the Juvenile Diabetes Research Foundation. He also has type 1 diabetes and, like many others who have the condition, he sometimes struggles to regulate his blood sugar levels.
"I'm a scientist and I work in the field and I don't achieve perfect glucose control," he says.
In that he is not alone: Some studies have found that even highly-managed diabetes—those who test their blood sugar more than eight times a day, still spend almost 70% of their day out of normal blood ranges—an average of more than eight hours with high blood sugar levels and two hours with low.
It's not about compliance, Kowalski says. Rather, it's about limited information—and the fact that computers can think about a lot of different things faster than humans. And, as it happens, Kowalski is working to create a computer-controlled "bionic pancreas" that will help humans better manage their diabetes.
I wrote about Kowalski and JDRF's artificial pancreas project in the March HealthLeaders magazine cover story, Medical Breakthroughs That Will Change Healthcare. But there are a lot of medical breakthroughs out there—advances in nanotechnology, wireless communication, imaging, OR technology, and more—and so I wasn't able to share everything from our conversation about the future of diabetes treatment.
A solvable problem that can change lives
"Today the person with diabetes does everything themselves. We call it the open loop," he told me. Patients gather information and do their best to respond to it. But even the most sophisticated patients and tools aren't perfect, he says. Diabetes is very difficult to control, even in the most compliant patients.
JDRF has gathered world class-doctors, mathematicians, and engineers, and has begun to work with private industry to create a safe, effective artificial pancreas that reacts to changing glucose levels and automatically delivers the right amount of insulin at the right time, he says.
It builds on two already-approved devices—the insulin pump and the continuous glucose monitor (CGM). But unlike an open-loop system in which the patient is responsible for testing, reading data, and taking corrective action, the automatic closed-loop pancreas would use a control algorithm to read and interpret the information from the device and respond by dispensing insulin when needed.
Like a natural pancreas, the device works continuously taking updated readings every one to five minutes to determine which way glucose levels are going. The next step is to tie that information together with a computer or control algorithm—software that sits in the pump and interprets the glucose level reading.
One huge benefit is that the device could take over for patients when they are most vulnerable and most likely to miss a CGM alarm—while sleeping or unconscious. In the closed loop system, the system would automatically intervene.
"This is a solvable problem," he says. "The research can be captured and turned into products that can change people's lives."
Intermediary steps toward the ultimate goal
Researchers are also working on a "semi-closed loop system" device. Kowalski likens this intermediary step to an autopilot system—it can do most of the work, but the pilot still monitors the controls and takes over if necessary.
"We think that there are going to be a series of products that will become more and more sophisticated," he says. The semi-closed loop system is "very near-term," he says, and will likely get quick FDA approval. He also thinks there is enough evidence to support the device so that, once it is developed, payers will cover it.
Although the ultimate goal is to find a cure for any disease or condition, including diabetes, these near-term advances will serve as bridges until then. "These intermediary steps are important while we fight to get to the end of the disease—to a cure. When you're living with a condition, you want something now . . . even if it's not perfect."
You can read about more medical breakthroughs in this month's cover story,Medical Breakthroughs That Will Change Healthcare: The devices, treatments, and procedures that will change the delivery—and the business—of healthcare.
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Amidst all the buzz about clinical data sharing and the accompanying alphabet soup of acronyms (EHRs, EMRs, PHRs, RHIOs and HIEs, not to mention ARRA and HITECH), it's easy to forget that the annual HIMSS conference is also a showcase for technology of the hardware variety—physical products and gadgets you can see, feel, and, in some cases, hold in one hand.
Keep in mind that there were about 900 vendors with booths in two exhibit halls so large you measure them not in square feet but in acres.
According to my pedometer, I walked about 26 miles over the course of six days—a literal marathon of keynotes, sessions, and tours of vendor booths. So with apologies to the other 896 vendors at the show, here are four products that impressed me. I have only one complaint about three of the technologies—along with many others at the show—but I'll get to that later.
Show me the way
I logged more than 15,000 steps on the first full day of the conference, in large part because I kept getting lost. While wandering aimlessly around I (finally) noticed one of the 30 NCR Wayfinding kiosks set up around the three conference halls.
Using a touch screen monitor, I entered the number of the booth I was trying to find (you could also search by company name) and up came an interactive map to my destination that I could print out and take with me. It's easy to see how the technology would help improve the patient experience, especially in large, aging, and sprawling hospital campuses.
The way-finding kiosk, made by Duluth, GA-based NCR is in use at Houston, TX-based The Methodist Hospital System along with some of the NCR's other products, including a patient portal and a payment manager.
Scan me
A compact, portable ultrasound machine that can be used at point of care, such as in a physician's office or the ER, GE Healthcare's Vscan is bulkier than a smart phone—but not by much. At 3 by 5.3 inches it weighs less than a pound. It has a wand about the size of a granola bar and a neat little USB docking station that syncs with a computer to upload images. The battery lasts for about an hour of scanning. The device is operated with a thumb wheel that looks a lot like the iPod control. And the voice recording feature means you don't have to have a third hand to operate it. Images from the device can be viewed and stored in the patient's medical record.
Although the main purpose of the device is clinical, because the size of most images is relatively small and come in common file types such as jpeg, mpeg, and mp3, patients can share them with friends and family online. You can annotate the images with a stylus—writing "It's a boy! with an arrow pointing to the proof, for example. The device uses "GE's high-quality black and white image technology and color-coded blood flow imaging," according to the company. I'm no clinician, but the sample images looked pretty good to me. And yes, you could tell it was a boy.
Entertain and educate me
Several products at the show aim to make patient education simpler and more enjoyable for the patient and less time-consuming for caregivers.
Using a remote or pillow speaker and a menu interface designed for a fifth-grade education level, patients can use the LodgeNetRX® Interactive Patient Television System to make non-clinical requests, such as ordering more pillows and blankets, or scheduling a visit from a case worker or spiritual counselor.
It also allows patients to view, on-demand educational videos customized to their illness or condition, order meals from menus customized to their dietary restrictions, and when they're ready for a break, watch videos of puppies customized to . . . well, the puppies aren't customized, but they sure are cute.
LodgeNet, based in Sioux Falls, SD, says that in most cases it can use a hospital's existing coaxial cable network and televisions to install the program and that it can interface with existing clinical systems for bedside care management. The product is currently in use at The University of Texas M. D. Anderson Cancer Center in Houston and the VA Medical Center in Washington, DC.
Drop me like a laplet
It's a laptop. It's a tablet. It's a . . . laplet? The most recent version of Panasonic's Toughbook® line of computers has a screen with three hinges—one that opens and closes the screen like a traditional laptop and one that allows the screen to rotate and fold into tablet mode.
Panasonic claims the "triple hinge design significantly reduces hinge failures." It's not exactly feather light (3.7 pounds with two batteries), but thanks to an ergonomic grip it was surprisingly comfortable to hold with one hand in tablet mode.
The computer has two batteries, which last up to 10 hours, and they're "hot-swappable," meaning you can pull one out and replace it without having to shut down the computer. Plus, the hard drive pulls out so that if something does happen to the computer (it can withstand impact from a height of about 30 inches) its data stays safe.
Similar to previous models, the keyboard has an irrigations system of sorts, protecting against liquid spills of about six ounces (200 ccs). Please let's not talk about the kind of liquids that might land on this laptop in the hospital setting, OK?
Sanitize me
There was one noticeable trend at the show—many of the products I demoed, including three described here, had touch screens. Wave of the future, right? Well as much fun as they are, there's an obvious problem in the hospital setting: infection control.
If you're going to have a way-finding kiosk in your lobby, you better have a hand sanitizer kiosk right next to it. I should know: I'm writing this week's column from home, where I'm laid up with the worst cold I've had in a long time.
And I totally blame the touch screens.
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In the near future, electronic health records and other health information technology will be as accessible and important as the stethoscope, the operating room, or the exam table. And there's no question that that the federal government will be required to support the acquisition of health technology, added National Coordinator for Health Information Technology David Blumenthal, MD, at the HIMSS convention in Atlanta last week.
"It will be assumed as a professional attribute," he said.
Blumenthal did talk about the meaningful use of EHRs—no question the hot topic at this year's conference—saying that the HITECH provisions are an "ambitious" and "evolving vision."
But he also discussed other ONC programs, saying that while the past year has been focused on policy, the office will "now begin the process of implementation."
Among the programs he highlighted were a regional extension program aimed at helping small physician groups, especially those in rural and urban areas with underserved populations, become meaningful users of EMRs and a program that will support community health information exchanges.
The ONC is not expecting change to happen by itself, Blumenthal said. And when change does come, it will begin at the local level.
He cited the Beacon Community Program, announced late last year, as an example—the agency received about 130 applications for 15 slots in the program, which will give $220 million in seed money to support communities that are expected to have higher-than-average EHR adoption rates. An additional $15 million will subsequently support technical assistance to the communities and an independent evaluation of the program.
Many communities have told the ONC that simply coming together to apply for these funds has changed the way stakeholders from different organizations interact. The process, Blumenthal said, may turn out to be more important than the relatively small number of facilities that will get the money.
Blumenthal, apparently still in an Olympic mood, compared the future of HIT to speed skating or downhill slalom racing. You have to move fast, you can't miss a turn, and you have to expect the unexpected.
"I'm optimistic. I think the wind is at our back in so many ways," he said. "So many see this as the audacity of hope—I see it as common sense."
Fair warning to health IT professionals: Harry Markopolos, the man who infamously warned the government that Bernie Madoff was up to something fishy, is setting his sights on Medicare fraud. And the first place he'll look for evidence is in your system's e-mails, documentation, and databases.
When Markopolos, who now works full-time investigating fraud, looks into a case, he always starts with the IT department. What does he look for? Bills submitted to Medicare by dead patients or from dead doctors, up-coding or billing for procedures that were not performed, and other fraudulent billing practices. He'll check your books for evidence of kickbacks, slush funds, and sudden inexplicable increases in revenue.
In a keynote session at the HIMSS conference in Atlanta Thursday, neurosurgeon and CNN medical expert Sanjay Gupta, MD, interviewed Markopolos about ferreting out fraud and waste in the healthcare system.
The government will increase investigation and enforcement, Markopolos said. And if they find evidence of fraud, it will be the IT professional's "worst nightmare," he says.
They'll start by shutting down your server farms and taking every piece of data they can find. Worse, they might let you think they overlooked some data, just to see if you'll produce it later upon request.
The cost of fraud
Estimates of the cost of Medicaid fraud range from $40 billion to $80 billion a year. The truth, said Gupta, is probably somewhere in between. "Fraud is everywhere, for sure," he said. And it affects "every taxpaying citizen of the United States."
It's "very common" for Medicare to get fraudulent claims from criminals posing as dead doctors, Markopolos said. Another problem—claims for an illness that does not fit with the patient's gender, such as a prostate exam for a woman.
"That's a problem," he said. (Or, suggested Gupta, men coming in for pregnancy treatment. "That's a bigger problem," Markopolos quipped.)
While Wall Street fraud robs investors of their money, Medicare fraud endangers lives and steals taxpayer dollars, Markopolos said. When a large healthcare organization is making money for illegitimate reimbursement claims, it harms other organizations that are playing by the rules.
"Medicare fraud is so pervasive, said Markopolos. "The risks of getting caught are so low and the return is so high."
The role of EMR
Electronic medical records can help identify fraud and reduce waste, Markopolos said. As systems gather and store more and more data, it will be easier to identify trends and outliers.
On the other hand, the lack of paper means there's one less trail to follow.
And EMRs themselves can be a source of fraud. For example, pharmaceutical companies can illegally pay for a high ranking on lists of treatment options. Markopolos says smaller practices, in particular, are susceptible if they use a vendor's pre-loaded formularies. Practices should create their own lists of medications, he said.
What to do?
Markopolos wants IT and other healthcare leaders to join him in the hunt for fraud. There are five ways they can help, he said.
Get educated. It's the first thing that IT and other healthcare professionals must do, Markopolos said. One way to do that is to get involved in professional organizations that have codes of conduct that members must follow.
Look for trends and changes in data. If a source of revenue jumps from 3% to 6% with no obvious reason, IT leaders should speak up. You can also compare data with other organizations in your area.
Beware of vendors bearing gifts. Gifts from pharmaceutical or medical device makers are "low-hanging fruit" for fraud investigators, Markopolos said. Even if an organization chooses a device because it really does best suit its needs, it is still fraud to receive any form of compensation from the maker—and can lead to jail time. "If vendors are sending you money, that's a big problem," Markopolos said. "You don't get paid enough to put on an orange jump suit." Consider following the lead of organizations that have banned all gifts from representatives and companies, he added
Do some profiling. Those with a propensity toward fraud tend to have a sense of entitlement, especially among doctors who feel they should be making more money. They rationalize their behavior, Markopolos said.
Blow the whistle. If you do see fraud, speak up—even if you were involved. Why? The government tends to treat whistleblowers well, protecting their identity and giving them deals in which they can avoid prosecution. The government is looking to identify higher-ups. To blow the whistle, go to the government, the press, or call an anonymous hotline. But don't go to your organization's lawyers, he said. Or, for that matter, anyone in the C-Suite. Rather, work with your chief compliance officer if you suspect fraud.
What's next?
The government will spend more money and get more aggressive about investigation and enforcement if the healthcare industry can't get fraud under control on its own, Markopolos said. "That's the future."
One tool the government might use? Undercover patients.
Undercover work has been "a proven law-enforcement tool," Markopolos said. And it could be coming to a hospital or physician practice near you. Patients who are well will visit doctors to see if they get treatments and procedures they don't need, or if the doctors bill for work they didn't do. Hearing aids, tie clips, or pens equipped with audio and video will collect evidence that's hard to dispute.
"It's probably the wave of the future," Markopolos said.
Healthcare IT leaders are already praising some aspects of HHS' proposed rule for testing and certifying EHRs, praising the decision to eventually turn the certification process over to the private sector, a fast-track certification timeline, and the ability for organizations to eventually certify EHRs from multiple vendors.
The proposed rule, released on Tuesday, would create a two-phase certification program. The first phase would allow organizations to get certified quickly in order to meet deadlines to apply for the first round of meaningful use stimulus funding—as early as October for hospitals and January 1, 2011 for physician practices and other eligible professionals. The National Coordinator would oversee that temporary process.
The second phase of the program would transfer testing and certification to private sector organizations. It would also allow certification of both completed EHRs and individual modules.
A better timeline
"They got it exactly right," says Simeon Schwartz, MD, president and CEO of WestMed Medical Group, headquartered in Purchase, NY. A stimulus, by its very definition, is meant to get people to adopt as early as possible, and the first phase of the rules will help his group be ready by January 1, 2011, the deadline for eligible professionals to qualify for meaningful use incentives. And it's not just about getting the money, he added. The timeline will improve patient care more quickly too.
But not all healthcare organizations—or all vendors, for that matter—are prepared to meet those first deadlines.
"It's going to be interesting to see how much the vendors got out ahead of this and how much they've hedged their bets," says Eric Saff, CIO of John Muir Health in Walnut Creek, CA, which uses McKesson and its RelayHealth product. "It's going to be interesting to see if all of the vendors can get there fast enough and give enough time before the hospitals and people put their plans together. Certainly the folks that haven't even started yet, I would doubt that they have any hope of getting it done anytime soon."
"Vendors are nervous that if they don't deliver on this their clients are going to be livid," adds Schwartz.
In private hands
Putting testing and certification in the hands of private sector organizations was also a smart move, Schwartz says. Meaningful use is a tremendously complex process and the government would likely be slower to adapt to changes in technology, he says. Besides, private certifying organizations have worked well in other situations.
Saff agrees. "It would be great to have a private organization do it because many functions to meet meaningful use require multiple vendors, and so it's going to be pretty difficult to cross the line if you don't have a matrix that says 'here's my 20 functions to meet meaningful use, here's my eight vendors, and now you've met the threshold for all eight and you get there,'" he says. "Typically, when you deal with the government, it's one at a time and if the one doesn't do it, then you can't ever seem to get to completion."
The testing and certification model would likely be similar to Joint Commission accreditation, in that hospitals would pay an organization to get certified, Saff says. "But it seems to me that would be way better than CMS or the IRS," he said.
Several HIMSS attendees also speculated that the Certification Commission for Health Information Technology (CCHIT) would be a good choice for a certification organization. Not surprisingly, CCHIT agrees.
In response to the proposed rule, Alisa Ray, CCHIT's executive director said CCHIT is confident about its prospects of becoming accredited. "CCHIT has four years of experience testing and certifying EHRs, and promptly adapting our testing to the latest federal standards. We have also been benchmarking our operations against best practices for certifying bodies, including the ISO/IEC accreditation standards, and we are well prepared. We plan to file an application with ONC as soon as they are ready to accept them."
She added that the announcement is "an important step that will reduce the uncertainty that the healthcare community has experienced while awaiting this additional information."
A modular approach
The modular approach will be helpful to health systems that have hospitals on several different EHR systems as well as those who use different vendors to manage different types of health information. "Many of us rely on more than one vendor," said Schwartz. His practices' main EHR vendor is GE Healthcare, but it also uses other, smaller vendors, including a third-party image management vendor.
"That provides an opportunity for the smaller players to contribute," said Luigi Leblanc of Solink, a Silver Silver Spring, MD-based vendor of MyOfficeLink, who was participating in the HIMSS "Interoperability Showcase," a real-time demonstration of standards-based interoperable health IT systems. "Because what you now have is no matter where you are in the chain of this market, you can in fact certify those modules as opposed to waiting until you meet complete meaningful use to be certified. So I think that's great. I think that's really considerate of the ONC," he said.
"To the credit of the health information technology standards panel, working on standards with industry, they've come out with standards defining meaningful use and I think that's going to help in terms of information exchange. And I think that's evident when you look at how large this showcase is compared to two years ago. I think people are in the spirit . . . of sharing and that's because government has had a role in helping to promote fair exchange."
Technology infrastructure can impact both the relative high cost and low quality of healthcare in the U.S., said Paul Tang, MD, vice president and CIO of Palo Alto (CA) Medical Foundation at a feisty "town hall" style discussion at the College of Healthcare Information Management Executives (CHIME) 2010 CIO forum held in Atlanta, GA, on Sunday.
"The government can't do it," said Tang, who is also the vice chair of the HIT Policy Committee and the chair of the Meaningful Use Work Group. "They don't have the expertise that's in this room and in the field."
Balancing privacy and access
There were audible grumbles from the experts in the room when talk turned to interoperability and privacy. It's a new era in terms of what systems can do, Tang said. And without access we put patients at risk. But will privacy concerns stand in the way of systems that can talk to each other across hospitals and other healthcare organizations?
Sharing patients' protected health information (PHI) is fine within one hospital or one healthcare system, said Deborah Peel, MD, founder and chair of the Austin-TX-based consumer advocacy organization Patient Privacy Rights. But, she said, most people do not want their information shared outside of their health provider's system. And there's some PHI they don't want to share at all, such as the medications they're taking, especially in fields such as mental health.
Her suggestion is to have an opt-in system that allows patients to choose how they control their information. For example, they might choose to allow the provider to share their information with other clinicians that the patient approves, but not for medical research. Or they might check off a box that says the provider must contact them before releasing any records.
That's when the grumbling reached its peak.
An audience member from a small rural hospital responded to Peel by saying his staff can't keep up with outgoing calls and can't afford to hire additional staff to call patients whenever they need to access their medical records. Even if they did have the money, the shortage of workers in his area would make it difficult to fill those jobs.
Panelist Elizabeth Johnson, RN, vice president of applied clinical informatics at Tenet Healthcare Corporation, said even a large organization like hers would find it challenging to notify patients before accessing their records. The key is to find the balance between privacy and the need to access information to provide care to patients, said Johnson, also a member of the HIT Standards Committee.
"We reject the balancing idea," Peel countered. If patients fear that their information will not be kept private, they will either lie, refuse to get treatment, or postpone care, she said. "If people don't trust it, they won't come in the door, or they'll come in the door late."
She also criticized single identifiers, saying the public has rejected use of social security numbers as ID for "decades," and adding that there is "no reason" not to get the information from patients at point of care.
"Right," mumbled one audience member. "Because patients never lie."
Other audience members had objections, too. If patients can edit their drug lists or hide information from some physicians but not others, one CIO asked, how do you prevent adverse drug interactions? "We have to give patients Miranda warnings," Peel said. In other words, she said, caregivers must tell patients about the risks of not disclosing all of their health information with all of their doctors.
She also said systems can be set up to catch adverse drug interactions and send the alerts directly to the patient.
I wonder if you can guess the reaction to that statement from those experts in the room who would be in charge of creating such a system. If you guessed grumbles, you'd be wrong—it was really more of a hybrid: a collective groan, sighs of frustration, and a mass rolling of eyes.
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