Saturday, March 20, 2010

Government Initiatives for Electronic Health and Medical Records Systems in the U.S., Issues and Barriers to a Rapid of Universal Deployment

Background

In 2004, President Bush issued Executive Order 13335 which called for substantial adoption of electronic health records (EHRs, or EMRs)[i] in private and public healthcare organizations within 10 years. “Additionally, the Medicare Modernization Act requires the establishment of a Commission on System Interoperability and the development of standards for electronic prescribing.”[1] These acts were intended to foster and promote the development and proliferation of national Electronic Medical and Health Records systems.

The following three paragraphs are taken from the 2007 report on “the major accomplishments” of the Health Information Technology Initiative by Health and Human Services Secretary Michael Leavitt since the Presidential directive was issued in 2004.

“Background: A Historical Perspective: Over the past 30 years, nearly every sector of the American economy has undertaken a sweeping transformation in the way information is collected, managed, and transmitted. The result has been consistently increased productivity and efficiency, and this shift has helped to secure America’s place at the top of the economic leader board.
Yet today, health care—one of the most significant sections of the American economy— has not made this transformation. However, this is beginning to change.
Today, evidence that use of secure, standards-based, electronic health records can improve patient care and increase administrative efficiency is overwhelming[2]. This use of interoperable health information technology (IT) will benefit individuals and the health-care system as a whole in profound ways.” [ii]
Specifically the 2007 report on “the major accomplishments” lists the following consumer and public health benefits:

Benefits to the health-care consumer:
· Higher quality care
· Reduction in medical errors
· Fewer duplicate treatments and tests
· Decrease in paperwork
· Lower health-care costs
· Constant access to health information
· Expansion of access to affordable care
Benefits to public health:
· Early detection of infectious disease outbreaks around the country
· Improved tracking of chronic disease management
· Ability to gather de-identified data for research purposes
· Evaluation of health care based on value, enabled by the collection of price and quality information that can be compared


These benefits, the report states, are the reasons behind the 2004 Presidential executive directive to establish an interoperable electronic health record system for most Americans, by 2014. (See the index for a more complete list of benefits [iii])
On April 27, 2004 the United States Department of Health and Human Services (HHS) was directed by President Bush in an executive order to create the new position of national health information technology coordinator. “The national coordinator is charged with providing "leadership for the development and nationwide implementation of an interoperable health information technology infrastructure," with the goal of establishing electronic health records for all Americans within 10 years.” [3] On May 6, 2004 HHS secretary, Tommy G. Thompson announced the appointment of the first person to be named to this position, Dr. David J. Brailer, MD, PhD.
Additionally, the national co-coordinator is “charged with improving healthcare quality, appropriateness, safety, efficiency, and coordination; improving market competition by improving the availability of information about costs, quality, and outcomes; and protecting patients' health information.”[4]
To fund the electronic initiatives the presidential budget for 2005 proposed $50 million in new state and local grants to support efforts for developing systems for health information interchange. Another $50 million was proposed for continuing research on how information technology could improve healthcare quality and safety. HHS was to report to the president on their recommendations for incentive options in their programs – that would encourage the adoption of health information technology and system interoperability capabilities.[5] [iv]
As early as June 17, 2004, Dr. Brailer, was already testifying before the House Subcommittee on Health, Ways and Means reported that HHS had already made the following significant progress.
· “SNOMED was licensed (Systematized Nomenclature of Medicine, a comprehensive set of clinical terminologies) to make it available without charge to everyone in the United States.”
· “As part of the Federal Health Architecture, clinical terminology standards were adopted across federal agencies through the Consolidated Health Informatics (CHI) initiative. The Department of Health and Human Services (HHS), Department of Defense (DoD), Department of Veterans Affairs (VA), and other Executive Branch agencies have endorsed 20 sets of standards, such as standards for medications, labs, and immunizations. These standards will make it easier for information to be shared across agencies and could serve as a model for the private sector.
· The Secretary created the Council on the Application of Health Information Technology (CAHIT), which has been the coordinating and internal advisory body for HHS. CAHIT has served as the primary forum for identifying and evaluating activities and investments that promote and/or complement evolving private sector initiatives and strategies.”[6]
In 2007, Michael O. Leavitt, Secretary of Health and Human Services department issued a report outlining the accomplishments of the first two years after President Bush’s executive order. (See link in the index for the report[v])

The report listed the following accomplishments:

Nine contracts were awarded for:
· Health Information Technology Standards Panel (HITSP) - To harmonize industry-wide health IT standards
· Certification Commission for Healthcare Information Technology (CCHIT) – To develop a certification process for health IT products
· Privacy and Security – To enhance safety of health information by addressing variations in policies and State laws affecting privacy and security practices
· Anti-Fraud for Electronic Health Records – To identify ways to enhance health-care anti-fraud activities with the use of health information technology
· Nationwide Health Information Network (NHIN) – To create prototype architectures for widespread health information exchange
· Adoption of Electronic Health Records – To develop a standardized way to measure adoption of electronic health records
· Clinical Decision Support – To form a group of qualified experts to advise federal activities concerning clinical decision support
· Health Information Exchange3 – To develop consensus for best- practice guidelines from existing, state-level efforts to exchange health information
· Hurricane Katrina Information Network and Digital Health Information Recovery Project – To foster widespread use of interoperable health IT in Gulf Coast regions affected by hurricanes in 2005

In May, 2006, the American Health Information Community (AHIC) delivered its first set of recommendations to the Secretary of HHS. The Secretary officially accepted these unanimous recommendations in four work group areas:
· Consumer Empowerment – To create a consumer-directed and secure electronic health-care registration information and medication history for patients
· Chronic Care – To use secure messaging, such as email, for communication between patients and their health-care providers
· Electronic Health Records – To create standardized, secure records of past and current laboratory test results that is accessible by health professionals
· Bio-surveillance –To enable the transfer of standardized and anonymized health data to authorized public health agencies within 24 hours

Additionally the report listed the following areas where specific objectives have been accomplished:

· Standards Harmonization – AHIC recommendations for “Interoperability Specifications” were approved.
· Executive Order on Value Driven Health Care - Executive Order issued requiring federal departments and agencies that purchase and deliver health care are required to use health IT interoperability standards.
· Product Certification – The Certification Commission for Healthcare Information Technology (CCHIT) certified the first 37 ambulatory—or clinician office-based—electronic health record products.
· Changes to Regulations - HHS issued new regulations to allow certain arrangements in which a hospital or other health-care entity donates health IT and training services to health-care providers.
· Health IT Adoption Measurement - a health IT adoption survey was conducted and established a current state base line of 10 per cent.

Despite President Bush’s initiatives, and the rapid progress of HHS in moving the objectives forward, the current administration has significantly altered the HER/EMR landscape. On February 17, 2009 President Obama signed the Health Information Technology for Economic and Clinical Health (HITECH) Act[vi], as part of the stimulus package (a.k.a. American Recovery and Reinvestment Act (ARRA)) which greatly expanded the scope and scale of the previous initiative to accelerate the development and deployment of EMR and EHR systems.

A main goal of the HITECH Act is to encourage the adoption of electronic health records (EHRs) through incentive payments to physicians. According to the Act, physicians are eligible to receive up to $44,000 in total incentives per physicians from Medicare for “meaningful use” of a certified Electronic Health Record (HER) starting in 2011. (Note: Physicians reimbursed by Medicaid can receive up to approximately $65,000 starting in 2011 based on state defined guidelines.) There are also disincentives and penalties for not participating. The HITECH Act has penalties and disincentives for practices that fail to implement an EHR system. If eligible professionals have not become "meaningful users" of certified EHRs by 2015, their Medicare payments will be reduced by the following schedule:
· 2015 Reduced by 1%
· 2016 Reduced by 2%
· 2017 Reduced by 3%
· All Subsequent Years: Reduced by 3%
It is also quite conceivable that these penalties and disincentives will become even more punitive as time goes on.
Barriers to Adoption
Some of the barriers are discussed in a paper by a group led by a UCSF researcher that appeared in the March-April 2009 issue of the journal "Health Affairs." Chief among these were cost, privacy concerns, design shortcomings and the difficulties encountered when sharing information across organizational boundaries. These issues along with some others to be discussed are critical barriers hindering broad implementation of electronic personal health records.
Cost
For physicians there are significant cost concerns. This is not only in capital expenditures, but also in practice disruption. An EHR system can cost as much as $200,000 or more initially. While there are some open source systems that can be obtained for as little as $20,000 but there is also the cost of ongoing maintenance, hardware, plus the costs of customizing the system.[7] The American Academy of Family Physicians has an online spreadsheet template available for help in estimating the acquisition and implementation cost of an EHR system. The bottom line, is an estimated 5-year total cost of ownership (TCO) for a small practice, of around $126,239 (2002 estimate) . [8]
More recent estimates are found in a “scholarly” study on EHR regulation by Case Western Reserve professors Sharona Hoffamn and Andy Pdgurski. Following is an excerpt from their article.[9]
“It is estimated that the cost of purchasing an EHR system is $33,000 for each physician, with an additional cost of $1,500 per doctor per month for maintenance. This expense has cost challenges for many providers, especially those in small practices.
A TCO projection would include all of the following:
 initial hardware initial software
 implementation, including system downtime
 management
 research of vendors & contracts
 service
 support & training
 administration
 upgrades & related re-training
 capital purchases
 direct and indirect labor
 subscriptions
 system integration
There is also a feeling by many that the “soft cost” savings would mainly benefit the public and private stakeholders. If these estimates area t all representative, clearly the HITECH reimbursement will not cover the investment required by the practice physicians and other healthcare organizations.
There also appears to be feeling among many that cost may not be the true underlying reason that physicians are slow to adopt EHR technology in their practices. Hoffman and Podurski observe that “some clinicians may resist computerization for more than just monetary reasons. There is concern that patients may suffer from less face to face time with their physicians if it becomes more time consuming for doctors to input information into a computer than it is to dictate notes. Others believe that EHR systems require time-consuming documentation of irrelevant facts, are difficult to navigate, and do not organize clinical information in a way that enhances the delivery of treatment.”
Privacy Concerns
Some consumer groups in particular are not happy with the Health IT Policy Committee’s recommendations released in July 2009 for EHR systems, which describe how doctors and hospitals may use electronic records and the due care required. A patient privacy coalition group, the Coalition for Patient Privacy says key privacy regulations need to be moved up from 2015, they are scheduled to be required, to 2011. They have expressed concerns about what it calls the policy committee's lack of attention to control over sensitive health information.[10]


Design Shortcomings

Below is a sample of design short comings being discussed on “Design of eHealth Records” discussion Posted by Dean Karavite on July 9, 2009 on the Design for Care,Design as a Critical Healthcare Profession. While not scholarly or journalistically rigorous, these practitioners certainly do represent many current concerns about EHR design. [11]
1. Design strategy of the contemporary EHR. Currently mimics paper processes. Decision support is rudimentary.2. IA/Usability of the contemporary EHR. Absolutely primitive. Vendors seem ignorant of all we have learned in other areas.3. Assessment of the current EHR. Jury is out on cost savings, productivity, improved outcomes and safety. What can we learn from how they fail?4. Implementing an EHR. A very $ and painful process. While we wait for the next EHR design, too many are already committed. Can we help design a better implementation process with the EHR's we have today? (my emphasis)5. Data and the EHR. Current design primarily focused on operational routines. Data access is difficult and complex. How can we make data access a higher level design requirement? Then, how we might go about designing to harness data in the aggregate, but also for the single patient at the bedside.6. Designing the EHR to promote clinician-patient interaction.The computer is taking over the exam room. How to design the focus back to interaction between the patient and the physician?
Interoperability Issues
Possibly the most challenging barrier to a broad and expedient deployment of EHR systems, is the issue of interoperability- a fundamental requirement of the HITECH Act. In the five years since President Bush issued Executive Order 13335 not nearly enough has been accomplished with respect to interoperability issues that hamper our national goal of portable and ubiquitous availability of patient health care data.
“In interviews conducted last summer with 22 health information technology experts from across the country, it was concluded by a January California HealthCare Foundation report based that, the nation's medical community is not substantially closer to an interconnected, interoperable EMR system now than it was in 2004.” [12]
There remain numerous issues including but not limited to technical, social, legal and policy-based issues. The number, proprietary nature, monetary and organizational investment and complexity of the legacy health care systems present a formidable barrier to data exchange and information portability. Even where viable technical solutions are at hand, the switching costs remain an enormous challenge. Even for small providers the monetary and organizational switching costs are a formidable problem.
“Interoperability is a fundamental requirement of ensuring that widespread electronic medical record (EMR) adoption gives us the social and economic benefits that we want.” Without it, EMR deployments will exacerbate the problem with information silos that exist today in paper-based medical records systems. This will result in even greater proprietary control of health information. Without interoperability, public support and funding would be questionable, since stand-alone EMRs might not increase the benefit to consumers, i.e. taxpayers. Interoperable information systems would increase consumers’ welfare through increased choice, portability, and control.”[13]
Conclusions
In July of 2007 a survey found that only 14% of physicians have minimally functional EMR systems. [14] The impediments to meeting the planned compliance milestones dates are significant and it seems highly unlikely that any can be met. The public funded monetary incentives appear to be inadequate to offset the projected capital and organizational costs of deployment. In this era of strained budgets and economic uncertainty, the propensity for capital risk taking especially in the microeconomic environment of the small practice is undoubtedly suppressed- especially given the widespread notions of questionable benefit. There is a cacophony of standards and technological approaches to vendor solutions. There is a steep learning curve that must be overcome for effective assimilation or the technical, institutional and organizational changes that would be necessary for a rapid successful deployment of ubiquitous EHR systems.
Following is a post on the EMR and HIPPA Open Forem for EMR, EHR, HIT and HIPPA related information by one Paul Roemer.
Regarding the HITECH objectives:
“I think the very question reinforces the magnitude of the issue. Providers have budgets for products whose cost they do not understand. They have implementation teams who have never implemented one. They are aiming at targets for certification and meaningful use, which from my perspective could just as well be written on an Etch-A-Sketch. Hundreds of committees work towards standards, a requirement forced upon them by hundreds of vendor applications and hundreds of Rhios.
The output of the recent HIT policy meeting shows just how befuddled the process is.
This is a mandated national roll out of EHR without half the required sources and almost none of the required leadership. Who is the decider?
The current failure rate for EHRs is understated due to the large number of small systems. The failure rate for those over $10 million will exceed the rate for large IT systems which is close to 80%.
A hospital CEO with who I met last month told me his peers are uniquely ill equipped to make these decisions. Decisions are based on what their friends did, what they read in a journal. They plan implementations based on meeting gossamer standards and tests. They do not base them on requirements.
Watch the dates move backwards. I think in 6-8 years the rolled out EHR will more closely resemble a single, national, browser-based open EHR.”
These seem to be credible observations. What then is to be done to improve the prospects for the most expedient deployment in order to to harvest the greatest potential value for stakeholders as soon as is possible? Probably nothing. The wheels of change are in motion and the entropy for forward movement- even if misguided, is probably too great to re-program. The substantial forces of the national healthcare infrastructure are at work for accomplishing this change and they will work themselves out over time (project performance will improve over time) – not the in the timeframes mandated by the HITECH Act, but in the timeframes necessitated by the realities of the technology, the scale and scope of the problems and the maximum ability of human beings and human enterprise to cope with change.
[1] Association of American Physicians and Surgeons, Inc, On-line Journal, Volume 60, No. 12 December 2004, http://www.aapsonline.org/newsletters/dec04.htm
[2] Walker, Pan, Johnston, Adler-Milstein, Bates, and Middleton: Health Affairs Online: January, 2005.
[3] Healthcare Financial Management Association, web page story, 2004, Copyright, 2004 the Gale Group
[4] Ibid.
[5] Ibid.
[6] Testimony: Statement by David J. Brailer, M.D., Ph.D., National Coordinator for Health Information Technology, Office of the Secretary, U.S. Department of Health and Human Services on Hearing: Health Information Technology before the Subcommittee on Health, Committee on Ways and Means, June 17, 2004. http://www.hhs.gov/asl/testify/t040617.html

[7] IM News, 8/15/04
[8] Jack Valancy. “How Much Will That EMR System Really Cost?” Family Practice Management. April 2002
[9] Sharona Hoffman, Andy Podurski. “Case Western Reserve University professors call for regulation of Electronic Health Records.” Case Western Reserve News Center, Online. October 30, 2008.
[10] Chris Silva. “EHR guidelines raise privacy concerns.” Amednews.com. Posted Aug. 20, 2009
[11] http://designforcare.ning.com/forum/topics/the-design-of-ehealth-records
[12] Dave Hansen. “EMR deadline does not compute: Falling short of 2014 goals.” amednews . May 19, 2008.
[13] David J. Brailer. “Interoperability: The Key To The Future Health Care System.” Health Affairs, The Policy Journal of the Health Sphere. Jan.19, 2005.
[14] Dave Hansen. “EMR deadline does not compute: Falling short of 2014 goals.” amednews . May 19, 2008.
[i] EHR vs EMR – What’s the Difference? By Houston Neal
I Posted on November 14, 2008 at 10:39 amhttp://www.softwareadvice.com/articles/medical/ehr-vs-emr-whats-the-difference/
EMR or an EHR? Do you know the difference? Is there a difference?
In theory, and by definition, there is a difference and it should play into any provider’s clinical software selection. At the same time, marketing messages and technical terminology have clouded provider’s understanding of the two software definitions.
Recently, National Alliance for Health Information Technology (NAHIT) established definitions for electronic medical records (EMR), electronic health records (EHR) and personal health records (PHR).
NAHIT Has Defined EMR and EHRThe NAHIT has produced the following definitions for EMR and EHR:
EMR: The electronic record of health-related information on an individual that is created, gathered, managed, and consulted by licensed clinicians and staff from a single organization who are involved in the individual’s health and care.
EHR: The aggregate electronic record of health-related information on an individual that is created and gathered cumulatively across more than one health care organization and is managed and consulted by licensed clinicians and staff involved in the individual’s health and care.
By these definitions, an EHR is an EMR with interoperability (i.e. integration to other providers’ systems). More on this later…
Who Needs Which?Marc Anderson, CEO of the AC Group, says it comes down to the words “medical” and “health.”
An EHR will provide a more comprehensive view into a patient’s health and history by pulling information from other systems, providing clinical decision support and alerting providers to health maintenance requirements. It will help providers report and measure quality indicators for pay-for-performance incentives.
Meanwhile, an EMR is a more silo’d record of a single diagnosis or treatment, most likely used by a specialist. If your responsibility is taking care of one unique problem – perhaps an orthopedist setting a bone – then a stand-alone EMR may well be sufficient. Certain specialists may not need information about patient history as much as they need specialty-specific workflows and templates.
The Market is Still Figuring it OutDespite the NAHIT definitions, we think the market is still figuring out which definitions to adopt. An analysis of Google Trends data shows that roughly four times more searches are performed for “electronic medical record” than for “electronic health record.” At the same time, “electronic health record” seems to be gaining in search frequency.
Google search frequency index by health care IT keyword phrase.
One interesting exception to the data: searches originating in Washington, DC are split evenly between “electronic medical record” and “electronic health record!”
Software Vendor Marketing Migrates SlowlyThe Google search trend data indicates an increased usage of EHR, but EMR remains more prevalent. The same is true when we look at the usage of terminology by software vendors.
In a review of 300 clinical records systems, 207 vendors market their software as an EMR, while 59 use the term EHR.
Why such limited adoption of EHR amongst vendors? First, it simply takes time and effort to change over marketing terms. Moreover, from a very practical standpoint, many vendors will want to continue to use the EMR label while it is the most commonly used – and “Googled” – term for clinical records systems.
Marketing Aside…Regardless of who’s using which terms, the key decision process for selecting an EMR/EHR is to map out your organization’s requirements and methodically assess systems against those criteria.
Justin Barnes, Chairman of the HIMSS Electronic Health Record Association (EHRVA) and VP of Marketing and Government Affairs at Greenway Medical Technologies, believes “the future of health care IT is interoperability.”
And while Barnes is an advocate of the EHR terminology, he distills the following three criteria for selecting a medical records system:
Current-year interoperability certification standards (CCHIT, HL7);
A unique workflow that matches your practice and specialty, and;
Excellent usability at the point of care.
If you purchase an EMR or EHR with these three requirements, you should receive a significant ROI on your investment, and position yourself to receive incentives from payers.
Well What’s a PHR?NAHIT has provided the following definition of a PHR:
ePHR: An electronic, cumulative record of health-related information on an individual, drawn from multiple sources, that is created, gathered, and managed by the individual. The integrity of the data in the ePHR and control of access to that data is the responsibility of the individual.
To be most effective, a PHR should include cumulative health information ranging from past and current illnesses, demographics, allergies, prescriptions and more. Given the nature of the PHR, it’s the individual’s responsibility to decide what information is stored, and who has access to it.
Microsoft’s HealthVault and Google Health are two prominent examples of PHRs. Whether these systems are widely adopted, and properly updated by patients, is yet to be seen.
So What Should I Implement?Even with complete definitions in place, it can be difficult to evaluate EMRs/EHRs and determine which system to buy.
At the same time, most providers will make their decisions based on their IT budget and their career stage. A young physician will almost certainly want to lay the IT foundation for participating in the future vision for healthcare interoperability. They will likely be supported in this effort by their health system.
Meanwhile, a more mature physician that wants to “go paperless,” but is not an aggressive adopter of IT, may well opt for a stand-alone EMR system and forgo the costs and challenges of integration.
In the end, these individual decisions underly what is a deliberate, but very slow, adoption of health care technologies.

[ii] http://healthit.hhs.gov/portal/server.pt/gateway/PTARGS_0_10731_848134_0_0_18/Accomplishments2006.pdf


[iii]
An Open Forum for EMR, EHR, HIT and HIPAA Related Information

http://www.emrandhipaa.com/benefits-of-emr-or-ehr-over-paper-charts/

Benefits of Using an EMR or EHR Over Paper Charts
Legibility of Notes – No more dealing with various handwriting styles since notes are typed.Accessibility of Charts – Indexed and easily searchable by multiple identifiers. No more searching the entire clinic for a lost paper chart.Transcription Costs Savings – Many users have been able to save on transcription costs by implementing an EMR.Space Savings – Many people are able to save space where they’d normally be storing shelves and shelves of paper charts.Eliminate Staff – This almost never happens immediately. Usually this happens through natural turnover of employees and usually occurs with your front desk or medical records staff.Eligibility for Pay-for-performance – It could take two years or more for you to implement an EHR and implement a meaningful quality improvement mechanism that would lead to your receiving payments from these programs.New Physician Recruitment – Many new physicians are looking for practices that use an EHR and will only work for an organization that uses an EHR.Multiple Users Use a Chart Simultaneously – Most EMR programs support multiple users accessing a chart at the same time. Many even allow multiple people to chart notes at the same time also.Lab Results Returned Automatically – This depends on a lab interface, but is more reliable and integrated with the care given.X-Ray Results Returned Automatically – This also depends on a X-ray interface, but has the same possible benefits of a lab interface.Save a Tree and the Environment – You won’t eliminate your use of paper, but you can significantly reduce the amount of paper/charts you use in your practice.Electronic Prescriptions – Scripts sent electronically or printed out avoid problems of legibility by the pharmacy receiving the script.Spell check – Many EMR software includes a spell check and often even include a medical dictionary.Disaster Recovery – Depending on your EMR backup schedule, you can store a copy of your data in multiple locations for better disaster recovery. Plus, in an emergency you could carry a backup of your data with you. Think about how you’d carry a room full of charts with you in an emergency.Drug to Drug Interaction Checking – Most EMR provide a database of Drug to Drug interactions when writing a prescription.Drug to Allergy Interaction Checking – Most EMR provide a database of Drug to Allergy Interaction checking when writing a prescription.Patient Safety? – Better information access, reduced gaps in communication between providers and reduction in duplicate testing.Quality of Care?Increased Efficiency?Better Patient Services?Improved Workflow?Improved Patient CommunicationsImproved Accuracy for Coding Evaluation and ManagementImproved Drug Refill CapabilitiesImproved Charge CaptureImproved Claim Submission ProcessReduced Medical Records Transportation Costs

[iv] April 27, 2004 Presidential executive order www.whitehouse.gov/news/releases/2004/04/20040427-4.html
U. S. Health and Human Service Department appointment of Dr. David J. Brailer, MD, PhD. As the first National Health Information Technology Coordinator www.hhs.gov/news/press/2004pres/20040506.html

[v] http://healthit.hhs.gov/portal/server.pt/gateway/PTARGS_0_10731_848134_0_0_18/Accomplishments2006.pdf

[vi] http://waysandmeans.house.gov/media/pdf/110/hit2.pdf

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