Clinical trials are essential for assessing the safety and efficacy of new drugs and new drug combinations. Despite their importance, there are flaws in how subjects are selected for such trials. Here's a quote from the Wikipedia about this issue: "In the US, the elderly constitute only 14% of the population, while they consume over one-third of drugs, Seniors are often excluded from trials because their greater health issues and drug use complicate data interpretation. Women, children and people with unrelated medical conditions are also frequently excluded (see: Clinical trial)." Another significant problem is that there is insufficient racial diversity among clinical trial subjects (see: Closing The Diversity Gap In Clinical Trials). Here's another article about this problem (see: Closing The Diversity Gap In Clinical Trials). Here is an excerpt from this first article:
...[M]ost of the clinical trials conducted in this country suffer from a pronounced lack of diversity. Minority populations are consistently underrepresented....This diversity gap can lead to sub-optimal development of new medicines and can further exacerbate minority health disparities. According to the Food and Drug Administration, while African-Americans represent 12 percent of the total U.S. population, they comprise just 5 percent of clinical trial participants. Hispanics account for 16 percent of the total population but just 1 percent in trials. A new study... shows that...non-whites comprise fewer than 5 percent of participants in NIH-supported studies....African-American men are twice as likely as their white counterparts to die from prostate cancer. Yet they represent just 4 percent of prostate cancer clinical trial participants....
There are a variety of reasons for the low rate of clinical participation among ethnic communities. Some are distrustful of clinical trials or understandably wary of sharing the most intimate details of their health in a clinical trial setting....There can be other practical matters that interfere....Transportation to and from clinical sites can be prohibitively expensive for some potential participants. Others can’t afford to miss work.The pharmaceutical industry recognizes that these issues can and must be addressed and is playing a lead role in forging solutions....Lilly has launched a first-of-its-kind program to train, mentor and equip minority investigators to conduct clinical trials that are well-designed and relevant to minority populations. For example, we have found that people are much more likely to volunteer for a trial if their contact person is familiar with their culture....
As someone who was a member of an institutional review board (IRB) tasked with the protection of subject enrolled in clinical trials, I can comment that there was always exquisite sensitivity about the possibility of subtle coercion in the selection of subjects. Here's a paragraph from the AMA about this topic (see: Subject Selection for Clinical Trials):
Ethical considerations in clinical research have traditionally focused on protecting research subjects. These protections may be especially important for those from socioeconomically disadvantaged populations who may be more vulnerable to coercive pressures. The benefits from altruism that result from participation in research, particularly for severely chronically ill persons, may justify equitable consideration of historically disadvantaged populations such as the poor.
So, for example, it is generally impermissible to pay subjects for participation in clinical trials other than to reimburse them for expenses, such payments constituting a form of coercion for someone of limited means. However, more affluent or more educated candidates for a clinical trial may be better able to take time away from work than others. Perhaps even more important is that more educated subjects may be less suspicious about representations that are made to them about the goals of a research project. Also, more educated people may have physicians who will make an added effort to identify suitable clinical trials for them or may even be conducting trials. Many of the barriers to diversity in clinical trials relate to societal issues that will not be solved overnight but we need to continue working in this direction.
By now, you’ve likely heard the news that Athenahealth has decided to quit the HIMSS EHR Association. As Athenahealth’s Dan Haley put it in a blog post: “At the end of the day, athenahealth left the EHRA because we never really belonged there in the first place. The EHRA was founded in 2004 by a group of EHR software vendors. Today, a decade into the age of cloud technology, the EHRA is still dominated and governed by a group of EHR software vendors.”
Athenahealth long has billed itself as a services company, not a software vendor, going so far as to hold a jazz funeral for the “death of software” at HIMSS13 in New Orleans. Athenahealth didn’t join the EHRA until 2011 anyway. It sounded like a bad fit.
I contacted Athenahealth, and was told that the company remains “fully committed” to the CommonWell Health Alliance, a coalition of health IT companies — also including Allscripts, Cerner, CPSI, Greenway Health, McKesson and Sunquest Information Systems — that came together for the stated purpose of “developing, deploying and promoting interoperability for the common good.” (There’s also the unstated purpose of fighting the dominance of Epic Systems.)
Athenahealth is staying on the interoperability path, but as is befitting the corporate culture, is going rogue when it comes to EHRs. It’s not the first time. It won’t be the last time, because it’s not like most of the other vendors/service providers, if for no other reason than CEO Jonathan Bush doesn’t fit the buttoned-down model of an executive. For that matter, neither did his co-founder, Todd Park, whom I often called an “anti-bureaucrat” during his time with the federal government. Park’s brother, Ed, is COO of Athenahealth, and also has unconventional tendencies.
I can relate to this mentality in a way. I quit the Association of Health Care Journalists years ago because it didn’t feel like a good fit for me. That group tried to include health IT in its programming, but it really was an organization for consumer and scientific reporters, not those of us in the business and trade press. Eight years later, I still don’t think the national media are doing such a great job covering health policy or explaining the nuances of this complicated industry. And, as I’ve said many times before about healthcare, the status quo is unacceptable.
Case Western Reserve University has an annual research day called Research ShowCase. I was privileged to be on the Program Board, chaired by Pete Zimmerman, Ph.D. Being both a former poster presenter and an Case alumni, made the event more meaningful. The event included hundreds of posters from post-docs, graduate students, undergrads and even high school students. The event had coverage by the Plain Dealer on this past Sunday including a slide show.
Robotics was a big hit as usual, but at Case, they are now experimenting with Biologically Inspired Robotics. See the video:
Other interesting exhibits included:
Looking forward to working on next year’s showcase.
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The Continua Health Alliance, mHealth Summit, and HIMSS launch a new non-profit called the Personal Connected Health Alliance that will represent the consumer voice in the growing connected health industry.
An Applied Clinical Informatics study says that using Epic’s Care Everywhere module in four Allina Health ER’s resulted in fewer duplicate diagnostic tests and procedures, and more drug seeking behaviors being identified.
athenaHealth announces that 95.4 percent of the company’s participating providers successfully attested for Meaningful Use Stage 1 in 2013.
CMS Principal Deputy Administrator Jonathan Blum will resign effective May 16, according to an internal email sent by CMS Administrator Marilyn Tavenner.
Hard times are coming for non-profit hospitals and, in my opinion, particularly for pathology and the clinical lab contained within them (see: Ratings Agencies Go Negative on Not-for-Profit Hospitals for 2014; Their Projections Signal Fewer Resources for Hospital-based Clinical Laboratories) Below is an excerpt from this article:
Tough financial times are ahead for not-for-profit hospitals, according to the projections of multiple rating agencies. Financial analysts attribute this to an extended period of massive and disruptive change. This is not good news for hospital-based clinical laboratory managers and pathology groups. Big Three credit-rating agencies...echoed a common theme in their 2014 outlooks for not-for-profit hospitals, which represent 60% of the nation’s hospitals. Environmental pressures will suppress revenue growth, while fresh cost-cutting measures will become increasingly harder to find....Revenue growth at not-for-profit hospitals will fall to roughly 3% to 3.5% in 2014....This compares to a growth rate of 5.2% in fiscal year 2012.
....Expenses grew faster than revenues for a second year in a row at not-for-profit hospitals....Not-for-profits have struggled to cut costs in an effort to improve margins. At the same time, these hospitals recognize they must reposition themselves in order to succeed in the new value-based reimbursement environment. That means they continue to invest in information technology and to expand physician practices as a source of referrals....Uncertainties following implementation of the Patient Protection and Affordable Care Act (ACA) will present additional challenges for not-for-profit hospitals going forward....Expanding Medicaid rolls will augment patient volumes. However,....,analysts are pessimistic that these increases will be enough to boost profits.
....Many not-for-profit hospitals have already implemented the most easily achievable cost-cutting measures....Now they are looking for options to push cost savings even further. Some strategies being considered include best practice definition and implementation, as well as clinical integration and productivity. However, some organizations will face roadblocks. Inadequate technology capabilities and cultural inability to achieve consensus could impede needed cost-saving initiatives.....The fact that multiple financial rating agencies predict tougher financial times ahead for a large number of not-for-profit hospitals is not good news for the clinical laboratory professionals and pathologists who work in these hospitals. Among other things, it means that medical laboratory budgets will continue to shrink and lab managers will be asked to do more with fewer resources.
When finances get tight, executives of non-profit hospitals tend to target the labs first for cuts. The perception is that the labs can absorb budget reductions without too much pain. This "logic" is based partly on the high degree of automation in the labs as well as the fact that they provide ancillary services without a direct relationship to patient admissions. All this despite the fact that pathology and the labs commonly account for only about five or six percent of the operating budget of most hospitals. This also despite the fact that hospitals will be facing a greater patient load coupled with the deployment of expensive new EHRs. Here's an article that details about the effect of EHRs on hospital budgets (see: EHR Jobs Boom: 8 Hot Health IT Roles). Below, for me, is the key quote from the article:
Electronic health records have fueled a growing career specialty. Consider these in-demand health IT jobs. Electronic Health Records (EHRs) have created a burgeoning genre of health IT jobs. While health IT once accounted for between 5% and 10% of a hospital's IT budget, it now represents 25% to 35%, Kevin Holloran, a director in Standard & Poor's nonprofit healthcare group told Beckers Hospital Review (see: EHRs and Health IT Projects: Are They Battering Hospitals' Financial Profiles?). A large portion of that money goes toward EHRs -- both in terms of technology and people.
So the budget for hospital IT, EHRs specifically, is at least triple what it used to be. This money needs to some from somewhere and the labs will undoubtedly be one of the first stops.
Continua Health Alliance, mHealth Summit, and HIMSS launch the Personal Connected Health Alliance to represent the consumer voice in personal connected health to ensure that technologies are user-friendly, secure, and can easily collect, display, and relay personal health data.
From Less Disruption Please: “athenahealth. Friday was a tough day. Their outage was apparently due to catastrophic loss of power. It took out email, production, and backup sites. At least they apologized.” Unverified.
May 1 (Thursday) 1:00 p.m. ET. Think Beyond EDW: Using Your Data to Transform, Part 2 – Build-Measure-Learn to Get Value from Healthcare Data. Sponsored by Premier. Presenters: Alejandro Reti, MD, senior director of population health, Premier; and Alex Easton, senior director of enterprise solutions, Premier. Once you deploy an enterprise data warehouse, you need to arrive at value as quickly as possible. Learn ways to be operationally and technically agile with integrated data, including strategies for improving population health.
Acquisitions, Funding, Business, and Stock
AdverseEvents, a healthcare informatics company focused on drug safety and side effects, closes $2 million in Series A financing.
Informedika changes its name to Health Gorilla.
Lexmark reports that revenues for its Perceptive Software division grew 38 percent in the first quarter.
Evangelical Community Hospital (PA) selects dbtech’s eFolder solution for enterprise content management.
Griffin Hospital (PA) will implement athenaCoordinator Enterprise.
UMass Memorial Health Care (MA) will integrate Luminat’s end-of-life directives platform into its EHR.
Alder Hey Children’s Hospital (UK) selects Summit Healthcare’s interface engine technology.
Missouri Baptist Medical Center will deploy the Vocera Communication System.
EHR/PM provider Pulse Systems appoints Richard Ungaro (RU Investment) SVP of operations.
NoteSwift hires Stan Swiniarski (Nuance) as VP of products and Art Nicholas (Nova Dynamics) as VP of sales and business development.
MediTract, a provider of automated contract management solutions, appoints Ed Caldwell (Emdeon) SVP of sales and marketing.
CMS Principal Deputy Administrator Jonathan Blum, the administration’s top Medicare official, will resign effective May 16.
Cancer Treatment Centers of American names Kristin Darby (Tenet Healthcare) CIO.
Announcements and Implementations
Athenahealth reports that 95.4 percent of its participating providers successfully attested for MU Stage 1 in 2013. The company also resigns from the HIMSS Electronic Health Records Association (EHRA) trade association saying it “never really belonged” since it is neither an EHR company nor a software vendor.
Maine’s HealthInfoNet HIE offers providers access to the state’s Prescription Monitoring Program through the HIE’s portal, giving clinicians a single sign-on to both systems.
Children’s Hospital of Philadelphia and Virtua (NJ) integrate their imaging systems as well as CHOP’s Epic and Virtua’s Siemens EHRs to give both health systems access to each other’s radiology reports and diagnostic images.
Prince Mohammed Bin Abdulaziz Hospital in Saudi Arabia deploys Cerner after a nine-month implementation.
Government and Politics
CMS officials are considering whether to keep Accenture as its long-term prime contractor for the the HealthCare.gov website or seek a potential replacement. A “sources sought” notice posted by CMS says the agency is looking to see if any small businesses owned by veterans or minorities might be suitable candidates.
Use of Epic’s Care Everywhere HIE tool helped four EDs within Allina Health (MN) reduce duplicate tests and procedures, according to a study published in Applied Clinical Informatics.
Boston Children’s Hospital (MA) partners with Etiometry to analyze information from ICU patient monitors to display a Stability Index.
Weird News Andy says patients have to pay for expensive ICU stays, but maybe this isn’t the best way. Police arrest a female ICU patient after a tip from hospital staff that she was receiving many visitors who stayed only 1-2 minutes. She was dealing heroin from her bed.
The following is a guest post by Barry Haitoff, CEO of Medical Management Corporation of America.
For those not familiar with ACOs (Accountable Care Organizations), I want to provide some insight into ACOs and how a medical practice can better prepare themselves for the coming shift in reimbursement, which is epitomized by the ACO. This is a challenging subject since the ACO is a somewhat nebulous idea that’s rapidly changing, but hopefully I can provide you some strategies that will help you be prepared for the coming changes.
You may remember when we talked in a previous post about the Value Based Payment Modifier and its impact on healthcare reimbursement. As we talked about in that post, healthcare reimbursement is changing and CMS is looking to only pay those providers who are providing quality care. As part of this movement, an ACO is an organization that works on behalf of a community of patients to ensure quality care.
The metrics of how they’ll measure what they reimburse and what they consider quality care are likely to rapidly change over the next few years while CMS figures out how to measure this. However, one key to being ready for this shift is that you’ll need to be part of an organization or group of providers that will take accountability for a patient population.
In some areas of the country, the hospitals are leading these organizations, but in other areas groups of physicians are coming together to form an ACO of just physicians. Either way can work. The key is that the members of these groups are going to each share in the reimbursement the group receives for improving the quality of healthcare patients in the community receive.
Also worth noting is that membership in an ACO isn’t necessarily a prerequisite for value based reimbursement. Whether you choose to be a member of an ACO or not, you’re going to be impacted by value based reimbursement and will need to be ready for the change. Not being ready could lead to lower reimbursement for the services you provide.
While it’s great that organizations of doctors are coming together to meet the need for ACOs, much more is going to be needed to do well in an ACO reimbursement world. The reality is that an ACO can’t exist without technology. Don’t even think about trying to meet the ACO requirements without the use of technology. ACOs will base their reimbursement on trackable data that can be aggregated across a community of providers that are likely on hundreds of different systems. Try doing that on paper. It just won’t happen.
In fact, many people probably think that their EHR software will be enough to meet the needs of the ACO as well. I believe this to be a myth. Without a doubt, the EHR will play a major role in the gathering and distribution of the EHR data. However, unless you’re a homogeneous ACO with providers that are all on the same single instance of an EHR, you’re going to need a whole suite of services that connect, aggregate, and interpret the EHR data for the community of patients. Add on top of that the communication needs of an ACO and the care manager style tracking that will need to occur and it’s unlike your EHR is going to be up to the task of an ACO. They’ll be too busy dealing with meaningful use and EHR certification.
Let me highlight three places where an ACO will need technology:
One of the key needs in an ACO is quality communication. This communication will happen provider to provider, provider to care manager, provider to patient, and care manager to patient and vice versa. You can expect that this communication will be a mix of secure text messaging and secure emails. In some cases it will be facilitated by a patient portal, but most of the secure messaging platforms for healthcare are much slicker and more effective than a patient portal that so far patients have rarely used.
Are you using a next generation secure messaging system to communicate with other providers, your staff, and the patient? You’ll likely need to use one in an ACO.
Provider Data Aggregation
Much like paper charts won’t be enough in an ACO world, faxed documents won’t be enough either. Providers in an ACO will need to have patient data from across the entire community of ACO providers. At a minimum providers in an ACO will need to have their EHRs connected with Direct, but most will need to have some sort of outside HIE that helps transfer, aggregate and track all the data that’s available for a patient in the ACO.
The ACO and doctor will really benefit from all the patient data being available at the click of the button. Without it, I’m not sure that ACOs will be able to meet the required quality measures.
Patient Data Aggregation
While all of the providers will need to be sharing their patient data, I think most ACOs will benefit from aggregating patient data as well. At first the ACO won’t be aggregating all of the patient generated data that’s available. Instead, they’ll find a slice of their patient community where they can have the most impact. Then, they’ll work with those patients to improve the care they receive. This is going to require ACOs to receive and track patient generated data. Without it, the ACO won’t have any idea how it’s doing. With so many patients on mobile devices or with access to the internet, what an amazing opportunity we have to really engage with patients.
Those are just a few of the ways technology is going to be needed for the coming changes in healthcare reimbursement and the shift towards value based care in things we call ACOs. Far too many providers are sitting on the sidelines while they let ACOs settle into place. What a missed opportunity. The fact that the ACOs are rapidly changing means that if you participate and make your voice heard, you can help to shape the direction of them going forward. We definitely need more doctors involved in these conversations.
Medical Management Corporation of America, a leading provider of medical billing services, is a proud sponsor of EMR and HIPAA.
Boston Children’s Hospital is piloting a predictive analytics tool in its cardiac ICU that it hopes will help combat alarm fatigue by predicting changes in patient condition before alarms sound, and then creating a real-time "heat map" of the unit that tells staff where resources should be directed next.
NPR reports on the medical scribe industry in the US, which is booming in parallel with EHRs.
Researchers at Harvard Medical School find that flu outbreaks can be predicted by monitoring spikes in traffic to Wikipedia pages about the flu and flu-like symptoms. The resulting annual figures were in line with CDC reports, and far outperformed Google Flu Trends, which predicts outbreak numbers based on Google search terms.
Healthcare.gov posted a message on Saturday informing users that all passwords had been automatically reset in response to the Heartbleed computer virus.
James Fallows wrote an article for The Atlantic about EHRs (see: Why Doctors Still Use Pen and Paper). You may want to browse this original article which is very interesting. He wrote a number of follow-up pieces and then an eighth one that quotes some of the email that he has received in response to the original article (see: The Electronic-Medical-Records Email(s) of the Day, No. 2). In this last one, he quotes an email from an IT consultant. Here is a truncated list of the observations about healthcare software in the email to Fallows:
I would like to make some comments about the idea of healthcare as a vertical market. I agree with the correspondent that most EHR software is pretty bad and also extremely expensive. I agree that part of the problem is that it's not developed by the "top programming talent." However, if you look at smaller niche markets within the larger medical software market like LISs and RISs, the software is generally good and "reasonably" priced. So, the question arises about how the EHR market differs from the LIS/RIS/PACS market. The following differences come to my mind:
Pertaining to the need for lab professionals to select LISs with optimum functionality, the Association for Pathology Informatics (API) now provides a LIS Functionality Assessment Toolkit that can be downloaded at no cost from the API web site.
In one of my recent interviews with a healthcare IT consulting company, they revealed some breaking news for those of us in the EHR world. They told me point blank that:
Meaningful Use is Not Covering Costs
Ok, so that’s not really breaking news. Although, it seems that very few people want to actually articulate this point. It almost feels like heresy that someone would “complain” about the fact that the government is spending $36 billion on EHR incentives and that the money isn’t enough to cover the implementation of these EHR systems.
Actually, I should clarify that last point. The EHR incentive money is covering the costs to purchase the systems. It’s not covering the costs of implementing those EHR systems and then poking, prodding and otherwise cajoling end users to show meaningful use of that system (not to be confused with meaningfully using the system).
Let me also be clear that I’m not complaining about the EHR incentive money. I’ve done enough of that previously. What I’m just trying to acknowledge is something that everyone who deals with the EHR budget already realizes, but no one seems to want to say it. Organizations are spending more money on EHR and meaningful use than they’re getting from the government.
I think this is important for a couple reasons. First, many organizations didn’t budget any EHR money beyond what the EHR incentive money. You can certainly argue this was a mistake on their part, but that’s going to leave a bunch of organizations in a lurch. We’re already seeing the fall out of this as news reports keep coming out about hospitals systems in financial trouble due to the costs of their EHR system. Plus, in each of these cases, it seems their costs continue to balloon out of control with no end in sight. It makes me wonder if the compressed meaningful use timeline is partially to blame for a rushed implementation and poor EHR implementation and cost planning.
Second, there is still a swash of providers and organizations that haven’t yet implemented their EHR. If you can’t support the cost of EHR with government money, how does that bode for those who won’t be getting any EHR incentive money? One could make the argument that they’ll actually be in a better position since they won’t have to worry about meaningful use and can just focus on getting value out of their EHR. Hopefully that’s the case, but many of the meaningful use functions are now hardcoded into the EHR systems. Even if an organization isn’t planning on attesting to meaningful use, that doesn’t mean they won’t be forced by their EHR software to do a bunch of things they wouldn’t have done otherwise.
What are you seeing from your perspective? Is the EHR incentive money covering the costs of an EHR implementation? What are the impacts if it doesn’t?
Next weekend is my medical school reunion. Although I can’t make it, the fact that it is happening spurred me to try to re-connect with old friends and colleagues. Some are from med school, others are from residency, and a few are friends I made when I was a young solo practice doc trying to figure out how to fit into the medical establishment.
I had a nice chat with a friend of mine who is a pediatrician. It was interesting to catch up because her practice is different from what I see every day. Hers is a traditional group private practice, but they only take commercial payers – no state or federal programs. As such, they’re not on the Meaningful Use treadmill. They document in paper charts that are filed by family rather than individual – totally old school as far as most health information management folks are concerned.
I had talked to her several years ago when they were trying to implement the same EHR that we were rolling out to our employed physicians. They had purchased their system through a local reseller, hoping to get good service from people close to home rather than buying directly from our vendor who is headquartered halfway across the country.
Unfortunately that local reseller was purchased by another reseller who didn’t have the greatest track record for customer service and most of their local resources were let go or quit. Because of that situation (coupled with turnover in their practice leadership), they had halted their implementation after bringing the billing system live.
They were heavy admitters to one of our hospitals, so I did a courtesy consultation to provide some advice on how to proceed. I talked to them about working with their reseller to come up with a phased implementation plan that would help them transition slowly since they weren’t in a huge hurry and had multiple older physicians who would need convincing and a lot of hand-holding.
We had run into each other in the newborn nursery almost a year after that, so I knew they continued to struggle with the system and ultimately went back to paper, although they were doing well with the billing system.
When I caught up with her a few weeks ago, I learned that they had made the decision to replace their entire system. They never got the EHR off the ground, largely because the older physicians perceived the software as too complicated and too clicky. They had not taken any upgrades since their initial installation in 2009, so I can see why they thought that – early versions of the software were indeed clicky and it wasn’t easy to save physician-specific defaults and preferences.
The practice had tried to re-implement on that version even though our vendor had since rolled out a redesigned user interface that vastly improved the workflow. She said that due to a lack of confidence in the reseller coupled with the physician resistance, they were afraid to take any upgrades.
They decided to go with a specialty-specific product, rolling out the practice management system first without any kind of conversion from their previous system. For a busy practice with nearly a dozen physicians, that surprised me – not even a demographic conversion. They went live on April 1 and every patient had to be re-registered, whether they were presenting for an appointment or calling in.
They made no adjustments to the schedule to accommodate the change because the providers refused to risk a revenue loss. As a result, they are running hours behind by the end of every day. Talk about an April Fool’s Day joke! Needless to say, no one is happy – the providers, the staff, or the patients.
Patients are complaining about the registration process because they have to provide information they didn’t previously, specifically race, ethnicity, and preferred method of contact for patient reminders. Sounds familiar! I asked her why they’re doing that since they’re not attesting for MU, don’t participate in any research or quality programs where those fields are needed, don’t do email or texting, and it’s not required by payers in our area (yet). The answer: those fields are required in the system and can’t be turned off.
I asked her how the system handles other information that may be needed for MU but not for the way the practice currently delivers care. She has no idea. I wouldn’t be surprised if there are plenty of other required fields that they’re not going to be happy about once they start implementing EHR.
I asked what their plans are for that. She didn’t really know whether they plan to implement EHR in 60 days, 90 days, or a year. There’s no burning platform, but I would expect a partner to at least have some kind of understanding of the group’s strategic plan. I asked about the family charting – which is very different from individual charting – and she had no idea how they plan to resolve that, either.
I’m sure I was giving her some funny looks during this discussion because my brain was positively spinning. They’ve traded one system (where at least they could have turned off those required fields) for another with no long-term plan for whether they’re simply converting to paperless charts or whether they plan to use an electronic health record to transform care.
I suspect that as time passes they’ll find themselves in substantially the same position they were in six months or a year ago, except they’ll be paying down another initial investment. I didn’t ask about the cost of the new system, but I hope that at least their monthly software maintenance payments are a little less. Until they start having some serious conversations with all the physicians though about what having an EHR means to them, what they want to get out of it, and how they plan to go about it, there is the potential for some serious unhappiness down the road. They’ll be doing the same dance but with another vendor.
Although they were never stressing about Meaningful Use, they were having mild heart failure over ICD-10 and were very grateful for the recent reprieve. As a relatively small single-specialty group, their transition will be less complicated (and hopefully less arduous) than some of ours and I wish them well. Given their payer mix and patient population, some of their challenges are different from those faced by my practices on a day-to-day basis, but many are the same. I left her with some good discussion points for her next practice management meeting and a promise to check in more frequently to see how they’re doing.
There are a fair number of physicians and practices in the market for replacement systems. I wonder what percentage of those purchases are truly from system deficiencies (including lack of certification)? I’d like to compare that to what fraction of them are due to a lack of understanding around how to successfully transition to electronic health records coupled with a vendor who is unable/unwilling to take a hard stance with its customers to force them to do things in a manner that will make them successful.
Are you in the market for a replacement system? What makes you think it will be different the second time around? How are you planning to do things differently? Email me.
Email Dr. Jayne.
The mandated use of SNOMED seemed to sneak up on healthcare providers, ninja-style. Like a ninja, it has the opportunity to silently deliver deadly blows: confusing care coordination efforts, confusing patients, and contributing to adverse risk scoring and underwriting analysis with private payers.
While providers and health IT professionals are accommodating SNOMED into clinical workflows and converting existing relevant data points to SNOMED to comply with CMS mandates, no one seems to be talking about the potential impact on patient care.
The requirement of SNOMED began innocuously enough. To qualify for Meaningful Use Stage 1 Core measures, CMS declared that Eligible Hospitals, Critical Access Hospitals, and Eligible Providers would record patient “problems” as discrete data rather than narrative text (typically, acronyms).
The Medicare and Medicaid EHR Incentive Programs do not specify the use of 1CD-9 or SNOMED-CT® in meeting the measure for this objective. However, the Office of the National Coordinator for Health Information Technology (ONC) has adopted ICD-9 or SNOMED-CT® for the entry of structured data for this measure and made this a requirement for EHR technology to be certified. Therefore, EPs will need to maintainan up-to-date problem list of current and active diagnoses using ICD-9 or SNOMED-CT® as a basis for the entry of structured data into certified EHR technology in order to meet the measure for this objective.
So, in 2013, providers were told there are two standards for recording structured problem data. They can choose ICD-9 or SNOMED-CT®. Since the objective states “list of current and active diagnoses” and they use ICD-9 for diagnose coding, it should be fine to use ICD-9, right? What’s the difference between an ICD code and a SNOMED code for the same ailment?
In Achieve (Meaningful Use Stage 2) Compliance with SNOMED-CT, Brian Levy gave an excellent synopsis:
Problem lists have been around a long time. Historically, and in many outpatient offices and clinics today, physicians have maintained paper problem lists in the front of patient charts that are updated during each encounter. The problem list basically acts as a running record of the major or chronic conditions suffered by the patient.
By contrast, the diagnoses coded within a practice represent the conditions that prompted the services rendered during a visit. In other words, the diagnosis codes describe the ailments that justify billing for the procedures performed. After a visit, a physician typically marks the appropriate ICD-9 codes on a superbill and sends it to the billing staff.
Geraldine Wade of Clinical Informatics Consulting used this simple SNOMED vs. ICD-9 visualization as part of her presentation to Hong Kong’s eHealth Record Office:
It seems simple enough: providers should use SNOMED when recording clinical symptom and diagnosis data, which doesn’t impact billing and reimbursement processes. Given time and adequate clinician training on the differences between SNOMED and ICD codes required for the same diagnosis, that process adjustment could be made.
Fast forward to 2014, the CMS issued clarification that the patient problem lists must be recorded only in SNOMED. Also, any patient diagnosis data already recorded in the problem list must resolve to SNOMED with all active problems, whether newly introduced or historic chronic conditions. Eden Ware described the collective provider reaction to this news in SNOMED: What It Is And Why It Was Added To Stage 2 Meaningful Use:
I can hear my provider colleagues screaming now. ‘No! We are already swamped trying to figure out ICD-10! We just want to care for our patients!’” She goes on to assuage their fears, with visions of IT automation to the rescue:
The good news is that the industry hears you, and products are available in the healthcare IT market to facilitate the translation of your problem lists into reportable, standardized SNOMED-CT codes. It will be important to ask your EMR vendors how they are handling this Meaningful Use Stage 2 requirement. Many vendors are utilizing “maps” between ICD-10-CM and SNOMED-CT to ensure this goal can be met. The mapping from the ICD-10 code to SNOMED-CT occurs behind the scenes, and is easily retrievable. However, the provider’s time is not affected and the goal for meeting this core requirement of Meaningful Use Stage 2 is ensured.
Presto! The SNOMED conversion problem is solved. There are a number of mapping tools available to address the linkage between ICD-9 and SNOMED, including the crosswalk provided by the National Institute of Health’s National Library of Medicine, which was created specifically to address the translation required for patient problem lists. EHR vendors are also building conversion features into their products, such as the Cerner Millennium example below, where a single click will instantly convert 40 patients’ ICD-9 code for CAD to the parent SNOMED code for coronary artherosclerosis:
One click, 40 patients’ records altered, all future C-CDA clinical documents compliant with Meaningful Use criteria.
But wait… We’re talking about a patient’s clinical diagnosis data.
IT geeks, in conjunction with EMR vendors and systems integrators, are going to be responsible for making an accurate determination of which ICD-9 diagnosis code maps to a SNOMED code? Is there any risk that these conversions might fail?
NLM blithely discloses the difficulty of achieving a perfect match (emphasis mine):
The Map tries to identify as many one-to-one maps as possible, however, due to the differences between the two coding systems, one-to-one maps cannot be found for some ICD-9-CM codes. This difference is usually due to one of two reasons. Firstly, in ICD-9-CM, some codes are “catch-all” codes that encompass heterogeneous diseases or conditions (e.g. pneumonia due to other specified bacteria). These codes, commonly known as “NEC codes” (not elsewhere classified codes), will not have one-to-one maps because of their nature. Secondly, since SNOMED CT is more granular than ICD-9-CM in most disease areas, some ICD-9-CM diseases or conditions are further refined as more specific concepts in SNOMED CT. For such cases, it is not possible to map to a more specific SNOMED CT concept without the input of additional information.
SNOMED is more granular than ICD-9 in most disease areas—not few, not some, but most.
Osteoarthrosis, the most frequently-occurring “unmapped” problem codes in the above image, has 20+ possible applicable SNOMED concepts related to the parent code 396275006 (Osteoarthrosis disorder), indicating more granular information such as site of osteoarthritis, or whether condition is chronic/endemic/degenerative, etc. Asthma has 25 possible derivations of SNOMED parent code 195967001 (Asthma disorder). Depression has close to 30 SNOMED codes describing parent code 35489007 (Depressive disorder), and the list goes on.
Here’s what the one-to-many mapping possibilities could mean to patients (including automated conversion tools):
The purpose of the SNOMED problem list is to inform all providers in the patient’s care continuum of any active or chronic conditions needing assessment and monitoring. With the single-click application of any given SNOMED code to an entire population of patients, it is highly likely that some, if not many, patients will be incorrectly assigned. It is unlikely that the patient will be clinically educated enough to identify, let alone explain, the difference to the network of providers participating in his or her care.
Is it reasonable to assume a patient suffering from severe asthma (370221004) would require a different care plan than a patient suffering from exercise-induced asthma (31387002)? How about the recently-discharged hospital patient who is suffering from asthma with irreversible airway obstruction (401000119107), referred to a primary care physician, whose Transition of Care problem list only states mild asthma (370218001)?
Sounds like a potential patient safety issue.
While the implications for care coordination are obvious and should be sobering, there are even more nefarious ramifications when you consider the EHR clinical data is also being shared with and consumed by insurance companies.
As more private payers are incorporating clinical document data into their member risk scoring and actuarial analytics, there are financial implications to the patient stemming from these automated (and, in some cases, arbitrary) mappings. The patient with mild depression (310495003) who is mistakenly coded as having major depressive disorder (370143000) may see medical insurance premiums increase, may experience a forced plan change with a reduced network of available doctors due to member attribution models applied based on clinical findings, and may have difficulty obtaining or renewing life insurance.
There are documented processes in place to rectify mistakes on consumer credit reports. This mandated SNOMED conversion introduces a new consumer protection need―how to address clinical data inaccuracies on a patient’s medical health record. A comprehensive process has yet to be introduced that would allow a patient to dispute a finding and have the information rectified at all points along the care continuum.
Is this what CMS had in mind when they mandated SNOMED for active and historical patient problems?
Welcome to the dark side of EHR interoperability.
— natalie hodge (@nataliehodge) April 21, 2014
I’m not sure I agree completely with this tweet. I don’t know enough about Covery My Meds to say either way. Although, I wondered if many EMRs will integrate with Covery My Meds. From my experience, EMR vendors don’t want to interface with many outside software companies. A few embrace outside companies interfacing with them. We’ll see if that changes over time.
— C. Michael Gibson MD (@CMichaelGibson) April 18, 2014
I haven’t had a chance to look at this study yet, but did anyone think that quality of care would improve because of MU?
Wellness tracking/apps mentioned in every #iht2 session so far. Reaffirms huge amount of patient data exists outside of EMR.
— Jennifer Dennard (@JennDennard) April 15, 2014
No doubt we’ll eventually have outside data from wellness tracking apps incorporated in EMR, but I don’t think it will ever be a free for all. There are tens of thousands of wellness apps and I don’t see doctors wanting data from just any app. They’ll want to only get data from apps they trust. That’s a high bar for most apps. Plus, once you win the trust of one doctor, you still have to win the trust of all the other doctors. There’s not a trusted third party that doctors look to for apps.
UPMC (PA) reports that hackers have stolen the personal information of 27,000 of its employees. 788 are reporting that their tax returns were stolen when the information was used to file fraudulent tax returns, while others are reporting that unauthorized bank accounts are being opened in their names.
HHS publishes a JASON report on health information interoperability which concludes that without a sophisticated data exchange framework, health IT will continue to struggle to improve care quality or reduce costs. The report recommends that Stage 3 Meaningful Use be used "as an opportunity to break free from the status quo and embark upon the creation of a truly interoperable health data infrastructure."
49 employees at T.J. Samson Community Hospital (KY) will lose their jobs, while most remaining employees will face salary cuts as part of a new plan designed save $3.6 million between now and October. CEO Henry Royse says the cuts were needed due to problems with a Siemens install which he summaries by explaining "One year after going live, the product’s inoperability is still costing the hospital tens of millions of dollars in unrecoverable bad debt, consultant fees, and lost productivity.”
In 2012, Medicare paid at least $6 million, but likely much more, to physicians that were actively suspended or terminated from state Medicaid programs for committing fraud, according to a ProPublica report.
Nuance is now officially in the medical image and document sharing business with their new acquisition. It’s not the first and won’t be the last as here’s another that opened last year. Features of course may not be identical but the main show here is to share medical images to avoid having duplicates done again for one and secondly the ability of physicians to share with each other as well as hospitals.
As I read here the platform will integrate with current medical records systems and images are stored in the cloud, where else:) Many medical records companies already have a document sharing module but this now incorporates the cloud and imaging which is a bit more complex. As I read through here there’s a dicom viewer built in so no separate software for that for those MRI and CAT scan images.
You need to become a member and I don’t know what the pricing is as I didn’t go that far. In addition PHRs have been in the image sharing business for a while with HealthVault as one example that has a built in Dicom viewer. That viewer comes in handy. You can read the links about the PHR aspect below.
The big plus here is for the built in capability for physicians to be able to have the information within a medical record as when else are you wanting to review medical images, when you are looking at the patient records. BD
Nuance Communications has announced today the immediate availability of Nuance PowerShare™ Network, the industry’s largest cloud-based network for securely connecting physicians, patients, and others to share medical images and reports as simply as people exchange information using social networks.
“This nationwide network, one that is fully integrated into the EHR workflow and already connected to approximately half of all clinicians producing diagnostic imaging information, is a ground breaking solution that delivers immediate benefits at an unprecedented scale to our healthcare system.”
“The challenge of sharing images with interpretive reports is something we’ve heard about consistently from our customers and EHR partners, and we know Nuance PowerShare Network will overcome this major obstacle, helping physicians treat patients more efficiently and effectively,” said Peter Durlach, senior vice president of marketing and strategy, Nuance Communications. “This nationwide network, one that is fully integrated into the EHR workflow and already connected to approximately half of all clinicians producing diagnostic imaging information, is a ground breaking solution that delivers immediate benefits at an unprecedented scale to our healthcare system.”
You’ve no doubt hear about the kickback scandal involving CareFusion and Charles R. Denham, MD, founder of the Texas Medical Institute of Technology (TMIT). I wrote a piece about it in the context of Meaningful Use for Healthcare IT News this month, since Denham co-chaired the steering committee of the National Quality Forum’s Safe Practices for Better Healthcare program during the time CareFusion allegedly paid Denham $11.6 million to promote its products.
CMS, of course, has, to date, based Meaningful Use quality measures on NQF recommendations.
Denham has become a pariah of sorts in patient-safety circles since the U.S. Department of Justice announced a $40.1 million settlement with CareFusion in January. Yet, believe it or not, TMIT is still in business. The organization’s Web site is functional; in fact, the “about” page prominently features a video with Denham. And the TMIT Twitter account is activem, promoting a webinar as recently as yesterday.
The TMIT High Performance webinar with Perry Bechtle begins in 15 minutes! Join now! http://t.co/rvuNDRI8td Password: Webinar1
— TMIT (@TMIT1) April 17, 2014
Perry Bechtle, D.O., is a neuroanesthesiologist at Mayo Clinic in Jacksonville, Fla., and a former U.S. Navy flight surgeon. I want to believe that his credentials are impeccable, but it’s hard to take TMIT seriously these days in the absence of a major house-cleaning. Interestingly, the last academic article Denham wrote before the scandal broke was in the December 2013 issue of the Journal of Patient Safety. It’s entitled, “Safe Use of Electronic Health Records and Health Information Technology Systems: Trust But Verify,” and co-authors include heavyweights such as David Classen, M.D., and David Bates, M.D.
How are we supposed to trust an organization that itself was wrapped up in such a serious breach of trust?
In a recent note, a guest blogger, Nial Toner, raised the issue of what I will call distracted diagnostics for the purpose of this discussion (see: Cloud Computing in Digital Pathology: Addressing Some Pressing Needs). Here is a paragraph from his note making reference to the fact that some pathologists working on digital cases away from their normal office might feel stressed or unfocused:
Some pathologists may be skeptical about working from many different locations and believe that system settings may affect how they deal with their daily case workload. The key argument here is that the pathologist working in his or her office environment is more likely to stay focused and therefore make more accurate diagnoses.
This is a very interesting point. We all understand the hazards of distracted driving and have seen cars weaving about with the driver holding a cell phone to his or her ear. Many states have outlawed the practice as unsafe. By the way, I purposely chose the term distracted diagnostics because the issue is even more relevant for the radiologist than the pathologist, digital images being more widely available in radiology.
I am thinking about a pathologist or radiologist interpreting images in a home office, perhaps alternating between household tasks and professional work. Increasingly common may even be the scenario of the review of a surgical pathology case or a radiology study with a cell phone, ducking out of a restaurant or party. Distraction has always been one of the known challenges of telecommuting.
On the other hand, it may be relevant here to ask whether the notion of distracted diagnostics is a red herring? Clinicians take cell phone calls all of the time wherever they are located. They frequently provide critical clinical advice with their hand over one ear to block out ambient noise in a restaurant. No one considers this a problem. In fact, we consider it appropriate and necessary.
I found a reference to distracted doctoring on the web site of a malpractice lawyer. Here, cell phones and browsing social media sites were highlighted as common distractions for physicians and other health professionals in hospital settings (see: Find out how a Tennessee medical malpractice lawyer can help). Here is a quote from the web page:
Doctors are without question busy during their day. Certain distractions are unavoidable due to the nature of their work. Other distractions are unnecessary in an operating room or examining room:
Distracted doctoring is more common than people might think. In fact, the ECRI Institute, an organization that researches ways to improve safety and quality of patient care, listed “caregiver distractions from smartphones and other mobile devices” as No. 9 on a top 10 list of health technology hazards for 2013. Stories have surfaced of doctors wearing headsets and making a personal phone call during a procedure.
I don't know whether distracted diagnostics is really a problem. It might be worth a study, perhaps starting with digital radiology.
I’ve regularly seen the divide (sometimes really wide) between the programmer and technical people in an organization and the healthcare professionals. For example, a healthcare IT company recently emailed me about an issue they had with their main developer. They asked the insightful question, “Is it possible to find quality developers who are not, shall we say, “difficult”?”
There’s no simple answer to this question, but let me first suggest that this divide isn’t something that just happens between tech people and non-tech people. I’m sure many doctors feel the same way when dealing with other people who try and do their job. It turns out, people are hard to work with in general.
That disclaimer aside, tech people do like to think they’re in a tribe of their own. Check out this video which definitely comes from a programmer perspective and illustrates the divide that often exists.
Just the fact that the programmer feels like they’re considered a “code monkey” describes a major part of the issue. Much like I wrote about today on EMR and EHR, one of the keys is making a human connection as opposed to treating a programmer like a code monkey that’s just there to do your bidding. While there are exceptions, most people respond to someone who deeply cares about the individual and works to understand their needs as much as the project’s needs or their own needs.
The reason I think there’s usually a big divide between the healthcare people and the tech people is that it’s a real challenge for these two groups to connect. The healthcare people don’t want to talk about Battlestar Gallactica and Game of Thrones and the tech people don’t want to talk about Dancing with the Stars and The Voice. Yet, this is what needs to happen to build trust between the two different groups. It’s a rare breed that enjoys both.
If all of this fails, then try the nuclear option. Bring donuts. Most people can relate to donuts.