Digitized Medicine

EHR Interoperability is a Nervous System

For those familiar with using email applications such as Outlook, Gmail or Apple Mail, it might not seem like it should be very hard to send and receive electronic health information.   But as it turns out, maintaining privacy, security, HIPAA compliance and electronic patient consent is very complex when exchanging electronic health data over the Internet.   It is not easy even for physicians and hospitals using fully functional EHRs.

Virtual Scenario:  Imagine that your patients’ electronic medical records are packaged in individual charged impulses that can propagate along the axons of a national health IT nervous system. This neuronal circuit provides the infrastructure needed to send one of those charged impulses containing the right information on the right patient to the right receiving provider whenever and wherever needed. As physicians know, the charged impulses will propagate along the tubular-shaped axon until they reach the terminal end, which does not directly connect with another axon. Instead, there is a gap or synapse which prevents the impulses from proceeding unless an intermediary event occurs. This constraint prevents chaotic, asynchronous transmissions of impulses that would result in unwanted movements or seizures. So, trusted intermediaries (i.e. neurotransmitters, ions) are needed at the gaps or synapses to enable axons to “talk” with one another in a standard and controlled manner. This allows the charged impulses to proceed in a synchronous manner. The axons, gaps, synapses and intermediaries must work together, or be “interoperable”, so that the charged impulses travel in a secure, coordinated manner all the way to their intended destination.

In this scenario the imaginary national health IT nervous system is analogous to the real-life health IT infrastructure being developed at the national and state levels through National Health Information Network (NHIN) Direct project and the State Health Information Exchange (HIE) Cooperative Program.   The charged impulses represent each patient’s electronic health information.  The axons represent each physician’s cable to the Internet.   The gap or synapse represents the present-day constraints on our ability to send and receive electronic health information to one another.   The trusted intermediaries represent local health information exchanges (local HIEs) and health information service providers (HISPs) that allow each physician’s axon to communicate through the Internet with axons from other physicians and hospitals.  The interoperability needed among all parts of the virtual health IT nervous system is analogous to the interoperability needed among all parts of the real-life health IT infrastructure including EHRs, local HIEs and HISPs.

The Nationwide Health Information Network (NHIN), through the NHIN Direct project, defines standards, services and policies at a national level for health IT interoperability.  At the core of NHIN Direct are trusted intermediaries that physicians can connect to in order to allow electronic health information to traverse the synapses between their axons and those from other physicians and hospitals.   These trusted entities are called health information service providers (HISPs). HISPs are able to authenticate the senders and recipients of electronic health information.   This provides verification regarding who really sent information and who really received it while also maintaining privacy and security while the data passes across the axonal synapses.

The Office of National Coordinator for Health IT (ONC) is making an effort to trickle down NHIN Direct standards and protocols to each state.   Through the State HIE Cooperative Program, ONC grants funds to states who submit plans to build statewide health IT infrastructure to support interoperable health information exchange.   In order to be funded the states must adhere to NHIN Direct standards.

For example, the Texas Health Services Authority (THSA) is using the grant funds to serve as a statewide convening entity that has gained consensus from a broad base of healthcare stakeholders on a three-pronged strategic plan for HIE in Texas:

1. Local HIE Program— Local HIEs are another type of trusted intermediaries, like HISPs, that physicians can connect to in order to allow electronic health information to pass across the synapse to the axons of other physicians, labs, radiology centers, hospitals or others with electronic health information. Twelve local HIEs were launched in 2011-2012 with partial funding through the THSA’s Local HIE Grant Program. Some are currently operational and actively providing HIE connectivity to physicians and hospitals in their area 
2. State-level IT infrastructure and services—The goal is to develop statewide infrastructure and services that can be used by local HIEs to help them provide HIE services locally as well as to enable exchange of data from one HIE to another (statewide HIE services); also to support a transparent governance structure and develop policies and strategies that guide maturation of statewide health IT infrastructure
3. “White Space” initiative—The goal is to make available basic health information exchange services to physicians and hospitals in regions of the state without local HIEs (the “white space”) by creating a marketplace of health information service providers (HISPs); physicians can apply for “vouchers” from THSA to offset the initial costs of connecting with the HISP they select.

Physicians should stay abreast of health IT interoperability efforts like these, especially those in their own communities like the local HIE efforts in Texas.  Physician input and involvement in these initiatives helps ensure health IT is spliced into the healthcare industry's genome in way that promotes high quality care.

Vendors Can Raise EHR Safety, Lower Business Risks Through Patient Safety Organizations

Physicians are disturbed when patient care is put at risk due to a problem caused by their use of an electronic health record (EHR).    Although they will generally tolerate the situation when their reported problem is effectively managed in a transparent manner, there are a number of situations that engender scorn for their vendor.   The most common scorn-generating situation is when they feel that the patient safety issue they reported has not received a high enough priority from their vendor.   These situations should, and often do, resolve when the doctor and vendor communicate a clear understanding of the problem and circumstances.  

But it is another situation that I think is much more frustrating.   A physician’s expectation is that EHR vendors respond to patient safety issues in the same manner physicians respond to adverse medical events.   Physicians engage in peer review activities to not only analyze and resolve a specific adverse event, but also determine a plan that reduces the risk of the adverse event happening again.  The most common peer review activities provide legal protections from discovery which promotes transparency and more effective management of the problem.  Physicians analogously expect EHR vendors to not only fix their problem, but also to transparently fix it for all other physicians using their product.   This puts EHR vendors in a quandary because the legal protections of peer review activities extended to physicians are not extended to EHR vendors.  

Resolving this problem will require assistance from the federal and state governments.    Along those lines the Office of the National Coordinator for Health Information Technology (ONC) published a Health IT Safety Plan on December 21, 2012, and is accepting public comments on it until February 4, 2013.   I believe the most important aspect of this plan is the development and use of patient safety organizations (PSOs) to identify, aggregate, and analyze health IT safety events and hazard reports.    

The aviation industry continually improves passenger safety by engaging pilots in self-reporting of errors and dangerous conditions through an offer of immunity from sanctions.   The federal Patient Safety Act of 2005 provides an analogous environment allowing physicians in the outpatient setting to voluntarily report and share quality and patient safety information to AHRQ-certified PSOs without fear of legal discovery.   Most physicians are familiar with the secure nature of communications when they are involved in hospital quality improvement activities.    The information, documents, discussions and committee reports generated under the hospital’s umbrella of quality programs are held confidential and privileged.   Privileged communications cannot be disclosed and used in medical litigation without consent.   PSOs offer an analogous umbrella of protection for physicians in the ambulatory setting.    Physicians may voluntarily report patient safety issues or quality data from their outpatient practices to a PSO on a privileged and confidential basis.    The PSO can aggregate and analyze information from multiple physicians and healthcare entities to help identify, prioritize and reduce hazards that impede quality care.

The legal protections offered to physicians through PSOs are not currently extended to EHR vendors. They should be, and I will endorse that change in my comments to ONC’s Health IT Safety Plan.   But even without this change there are ways for EHR vendors to safely engage with PSOs today.    Let’s consider one such scenario:

Fictional scenario:  Community physicians and several EHR vendors are associated with the same patient safety organization (PSO). Dr. X is one of the physician members and his EHR vendor, VendorZ, is an analytical contractor with the PSO. After entering a digoxin dose in his EHR’s Medication Reconciliation screen, Dr. X discovered that the dose displays with a misplaced decimal point on the Medication History screen. He reports this dangerous dosing error to his PSO as a patient safety issue. The PSO notifies VendorZ. VendorZ begins working with Dr. X’s office to resolve the issue. Because VendorZ is an analytical contractor with the PSO to which this patient safety issue was reported, the reported problem, analyses, results and recommendations are confidential and privileged. When a solution is identified, there is no legal threat that disincentivizes the PSO or VendorZ to withhold this known problem and solution from other physicians in the PSO who use the same EHR. The PSO notifies all of those physicians who are members of the PSO and proactive work is done to prevent this same problem from harming patients in other practices.

EHR vendors are not inclined to openly discuss EHR problems when there is the threat of litigation against them for doing so, similar to fears physicians have with discussions of their own medical errors.   But this fictional scenario exemplifies one plausible way for EHR vendors and physicians to collaborate on health IT risks today under the protective umbrella of PSOs.

As stewards of safe, quality care physicians should have a basic understanding of PSOs and carefully consider opportunities that arise to engage with a PSO on initiatives to improve outpatient care in their community.   EHR vendors should demonstrate a similar stewardship by helping educate physicians about PSOs and engaging with physicians through PSOs to improve the safety of their EHR products.

CMS Decision on ICD-10 Spurns Optional Path to ICD-11 Without Comparing Value

 

"The decision to mandate ICD-10 for covered entities has already been made."  

This response in the ICD-10 final rule published last Friday by the Department of Health and Human Services (HHS) bluntly spurns the option of foregoing ICD-10 to implement ICD-11.   HHS predictably argues that the considerable investments already made by healthcare organizations into ICD-10, the years of rulemaking with previous analyses of ICD-10 value/costs and the "uncertainties" over the timeline and value of ICD-11 all justify a decision to eliminate ICD-11 as an option.  

I am disappointed that HHS made no estimates on the comparative value of ICD-10 to ICD-11.   Instead of comparing the total cost of proceeding with ICD-10 and then implementing ICD-11 to the total cost of foregoing ICD-10 to implement ICD-11, HHS candidly explains that "we do not participate in this debate in this rule, except to say that we are convinced of the benefit of ICD-10 to health care delivery in this country."  There clearly was no intent to revisit a previous decision to implement ICD-10, even though there is an opportunity to gather and analyze new information to assure we make an informed decision on the optimal pathway to an inevitable ICD-11 implementation. 

The final rule dismisses the call from several commenters on the proposed rule for an analysis of the total costs of the two pathways to an ICD-11 implementation.   One argument made against such an analysis is that the "the disruption and costs of transitioning to ICD-11 are highly unlikely to be less those of transitioning to ICD-10."  I agree that each individual implementation may have comparable costs, but that does not compare the cost of the two pathways which are: 

1. Implement ICD-10, then implement ICD-11 (two complete implementations)
2. Forego ICD-10 to implement ICD-11 (one implementation + sunken ICD-10 investments)

What is the comparable cost of each pathway? A comparison of the cost and benefits could have a significant impact on the decision.  Let's learn from this for next time. 

By the way, there will soon be a next time.  I fear that this decision locks the U.S. into another cycle of the same-- using a diagnosis coding system that rapidly becomes archaic and leads to another decade of desperate efforts into the 2030s to upgrade after the rest of the world has already transitioned to ICD-11.

I also fear that that the burden will be excessive on healthcare organizations in 2014 to implement ICD-10 and meet the 2014 Stage 2 Meaningful Use requirements which were both announced by CMS this week.   This burden will be greatest on the small, individual physician practices are already throttled by meaningful use, 5010, e-prescribing and healthcare reform.  They are struggling to find the time and resources for the ICD-10 effort. Since the EHR Incentive Program has a specified timeline under ARRA, I believe this excessive burden is likely to trigger another delay of ICD-10, at least for small physician practices.  

Will we be left wondering why we didn't just stop investing in ICD-10 back in 2012?

CMS prematurely dismisses the alternative option to forgo ICD-10 and implement ICD-11

In their proposed rule to delay ICD-10, CMS prematurely dismisses (in three short sentences) the alternative option to forgo ICD-10 completely and implement ICD-11 instead.    I am very concerned that this  dismissal is published  without a comparative analysis of the total costs of each option.   And there is good reason to seriously consider implementing ICD-11. 

In a recent Health Affairs report  the authors express concerns that adopting ICD-10 for reimbursement will be disruptive and costly with little material improvement over the current system.  These informatics experts fall short of suggesting we forgo ICD-10 for ICD-11, but they do recommend that policymakers begin planning now to facilitate a tolerable transition to ICD-11.   We should recognize that this article was not an appropriate platform for the authors to make a political statement to forgo ICD-10.   In addition, more information is needed before making such a recommendation:

1. What is the earliest date by which the U.S. could implement ICD-11?  CMS suggests that it could be as early as 2020-2022.  What could be done to possibly accelerate that date?
2. What is the earliest date we could implement ICD-11 if we implement ICD-10 first?  Historical data suggests 2028 is the earliest, but some informatics experts suggest it will be after 2030.
3. What is the estimated total cost to complete the ICD-10 implementation, then convert to ICD-11?
4. What is the total cost of stopping the ICD-10 implementation today and proceeding with ICD-11, including the sunken costs of work already done on ICD-10?
5. What value will ICD-11 provide over ICD-10?
6. How does the total cost to the industry for using ICD-9 codes another 5-7 years (while ICD-11 is implemented) compare to the total cost to the industry for using ICD-10 codes instead of ICD-11 for 13 or more years after ICD-10 is implemented?
7. What additional burden will be imposed on physicians and small hospitals by requiring two code system conversions over the next 15 years?  What are the capital costs physicians and small hospitals will incur under both pathways? 
8. What other potential impacts could there be on physicians and small hospitals?   Will it drive an increasing number of physicians into early retirement?   Will some small hospitals be forced to close?   Will it drive a decision by increasing number of physicians to convert to a concierge or cash-only practices?  

These and other potential impacts have not been fully assessed by CMS.   Implementing ICD-10 has been compared to buying a Betamax instead of a VHS recorder in terms of pending obsolescence.   Informatics experts are in agreement that ICD-11 is superior to ICD-10 and that we need to get to it as soon as is tolerable.   Perhaps the optimal pathway to ICD-11 really is through the ICD-10, but we need a more comprehensive analysis to make a better-informed decision.   Let’s put on the table the total costs and impact of both pathways and then decide.

You may read here my entire public comment as submitted to CMS on the proposed rule to delay ICD-10 for one year.

Healthcare Industry's Triple Strand of DNA: health IT, payment reform and patient empowerment

Earlier this month I used a genetics anology to describe the amazing progress with electronic health record (EHR) usage by physicians over the past two years (see Progress being made to splice information technology into the healthcare industry's genome in Texas).   Facilitating this progress are the EHR Incentive Program and other federal health IT initiatives that the Office of the National Coordinator for Health IT (ONC) oversees. 

Last Thursday the National Coordinator of ONC, Dr. Farzad Mostashari, took my genetics analogy one step further in his keynote speech at the HIMSS12 Annual  Conference for health IT in Las Vegas.   And I have to admit that he improved upon it.  I guess that's why he's in Washington D.C. and I'm not. 

Dr. Mostashari warned the 36,000  conference attendees that along with this continued progress there are two other societal trends to align health IT with.   He advocated for "twisting health IT to create a triple strand of DNA" with payment reform and patient empowerment. 

Health IT, payment reform and patient empowerment.  The triple strand of DNA to splice into the healthcare industry.  I like that. 

Payment reform is seriously needed to align incentives with the provision of quality care in an efficient manner.   Right now I am basically paid to "encounter" patients and to do procedures.       Although I am personally motivated to provide high quality care, the incentives are oddly there for physicians to "see more" and "do more" rather than to "see it done best".     In addition, my documentation is based on meeting reimbursement rules to make sure I get paid rather than being based on communicating a clear picture of my findings and care plan.   I absorb the extra time it takes to do both.

Consequently it is no surprise that for decades EHR vendors developed products based on episodic care.    Physician's sought out products that would help them document and get paid for patient encounters.  Documentation templates and charge capture functionalities were developed to maximize chances for reimbursement.    

The potential for EHRs to improve quality and chronic disease management is just now starting to be realized.    The ONC's health IT initiatives enacted by CMS under the HITECH portion of the 2009 Recovery Act are providing the push.   But as payment reform proceeds, whether it be value-based purchasing, accountable care or some other program, EHR vendors will be incentivized even more to shift development efforts into chronic disease management and clinical decision support that are a basis for improving patient care. 

And the third strand of DNA to splice into the healthcare industry, patient empowerment, is indeed an active and growing societal influence.  But I will have to blog about that another day...

Progress being made to splice information technology into the healthcare industry's genome in Texas

It's amazing-the progress being made to splice information technology into the health care industry's genome.   When I first dove into health IT a decade ago the use of electronic health records (EHRs) was dismal and healthcare stakeholders rarely sat at the same table with mutually beneficial, collaborative objectives in mind.   Even within the same healthcare organization it was not uncommon for individual department leaders to disrupt an integrated health IT effort in order to protect some of their department's self-interests.   Less than 5% of hospitals had implemented fully functional computerized provider order management (CPOM) systems; less than 1 in 5 physicians were using an ambulatory EHR; and less than 5% of those were fully functional EHRs.    Today the percentage of physicians and hospitals using robust EHRs is rising at a rate that was unthinkable back then.  

This progress parallels the launch of health IT initiatives established through the federal HITECH funds such as the EHR Incentive Program.   In the past two years these funds have been a catalyst here in Texas to engage diverse groups of healthcare stakeholders  to use health IT to improve quality of care.   As a result:  

• Increasing numbers of Texas physicians are using EHRs (approaching 50%)
• More and more hospitals are using CPOM
• Over a dozen of community-wide health information exchanges (HIEs) are up and running
• New health IT workforce training programs are established
• Four regional extension centers were formed covering all geographic areas of the state and are doing a phenomenal job assisting thousands of physicians with EHR selection, implementation and meaningful use
• Texas became the first state to have it’s HIE plan approved by ONC
• Texas was one of the first states to stand up the Medicaid EHR incentive program making our program a model for other states
• Texas was one of four to receive a SHARP grant
• And Texas leads the way with the number of physicians attesting to meaningful use; Texas physicians and hospitals have received over $270 Million in EHR incentives

This rate of progress is only possible when individuals with diverse backgrounds and from different healthcare stakeholder groups are able to collaborate.  In Texas these stakeholders have demonstrated an ability to park their self-interests in order to drive forward with a common vision to improve the quality and delivery of patient care in our communities.

Improve Physician Leadership Through Recruitment, Education and Training

A recent discussion among my colleagues about increasing physician leadership in this age of electronic health records (EHRs), Meaningful Use, healthcare reform and Accountable Care Organizations (ACOs) caused me to think about how a physician even starts to go about becoming a leader.   I considered physicians in my own community who are recognized leaders and appreciated that their rise to leadership started by simply getting involved in something.   Their leadership was born out of getting involved just like my colleagues were doing when they began discussing solutions to this particular issue!

Getting involved is a common attribute of physician leaders because there is obviously little merit or trust when a physician leads an effort without previously participating in a similar effort.   Participation is the initial step to gain such trust.   Once a physician gets involved with a successful initiative their community deposits a “coin of trust” into his pocket.    If the physician obstructs progress, though, some coins of trust are removed.   A physician who eventually collects a pocketful of coins is looked upon as a trusted “community leader” who is knowledgeable and experienced, even if he did not actually “lead” any effort.  This is because many successful healthcare initiatives are known to be moved forward by people who are catalysts for collaboration and effective at resolving conflicts between stakeholders.   One does not have to be an ACO board chairman or a formal project leader to be such a catalyst.  In fact, it is often advantageous to be in a more neutral position when exerting that type of influence.

So an increase in physician leadership will initially involve an increase in physician participation in healthcare initiatives.   A good place to start is with local health initiatives such as a Regional Extension Center (REC), health information exchange (HIE)  or Accountable Care Organization (ACO).   Participating in a local initiative provides physicians with the valuable experience of working together, perhaps for the first time, with multiple stakeholders.  Physicians will see the types of communal efforts that are successful at promoting change.  They will gain valuable knowledge about healthcare reform, health IT or other important topics.   They will learn how public policy is developed. They will encounter the frustrations and complexity of efforts that fail.   But they will learn to keep their focus on the long term and not be deterred by a short term failure that they come to realize will not matter at all in 40 years.     

Understanding this process illuminates a path to increase physician leadership.  It starts with the active recruitment of physicians into local, statewide or national activities.  It is accelerated through concurrent education and training to hone leadership skills.  County and state medical societies, who have established physician relationships and are experienced with physician education/training, are ideal entities to facilitate the growth of leadership.  The medical societies could actively identify new and ongoing healthcare initiatives and contact them to ensure there is adequate physician participation.   They could also assist with physician recruitment and training when needed.

EMRs create a new medical liability risk-- physician's failure to chase after the non-compliant patient

It is clear that electronic medical records (EMRs) improve patient safety and quality of care in many ways.  It is unclear, however, whether these improvements will result in an overall reduction in medical liability risks and costs.  Consider the following scenarios:

Scenario 1: You are the doctor and you have a 20 year-old female patient, Ann, with insulin-dependent diabetes mellitus who has been an ideal and compliant patient.  When you last saw her 3 months ago you wrote an office note about how her paper log of glucometer readings (that she faithfuly brings in each visit) showed an exellent trend of glucose levels and compliance with her diet and insulin regimen.  A Hgb A1C test was done and the result satisfactory.  Today an emergency room doctor calls you and reports that Ann is comatose with a blood sugar of 650 with other signs of severe ketoacidosis.  You admit her to the intensive care unit where she is treated aggressively but cerebral edema develops resulting in a stroke.  Upon recovery from her metabolic crisis she requires rehabilitation for residual left-sided weakness.  As you piece together her story you discover that since you last saw her she had apparently become acutely depressed after breaking up with her boyfriend.  She now admits to straying from her usual dietary restrictions, failing to take her insulin regularly and not monitoring her blood sugar.  You explain to Ann and her family that her depression obviously led to non-compliance with her diabetes therapy which unfortunately resulted in her poor outcome.

Scenario 2: You are the doctor and you have a 20 year-old female patient, Ann, with insulin-dependent diabetes who has been an ideal and compliant patient.  You last saw her 3 months ago and in your EMR you noted an excellent trend in her daily blood sugar readings that she faithfully sends to your office in real-time (by connecting her home glucometer to the internet through her Xbox).   A Hbg A1C test was done and the result satisfactory.  Today an emergency room doctor calls you and reports that Ann is comatose with a blood sugar of 650 with signs of severe ketoacidosis.  You admit her to the intensive care unit where she is treated aggressively but cerebral edema develops resulting in a stroke.  Upon recovery from her metabolic crisis she requires rehabilitation for residual left-sided weakness.  As you piece together the story you discover that since you last saw her she had apparently become acutely depressed after breaking up with her boyfriend.  She now admits to straying away from her usual dietary restrictions, failing to take her insulin regularly and not monitoring her blood sugar.  When you look in your EMR it is obvious that she stopped sending in her glucose levels 8 days ago.  You were on vacation and the alerts generated by the IT tools were somehow missed by your office personnel.  You explain to Ann and her family that her depression obviously led to non-compliance with her diabetes treatment which led to a severe ketoacidosis complicated by a stroke.  Ann’s parents ask why you would not have checked up on her when she stopped sending in the glucose readings.  They blame you for the poor outcome and file a medical liability suit against you for failing to follow-up on their daughter after your records showed she had become non-compliant. 

The above scenario demonstrates one of several new liability issues raised by the use of electronic health records (EHRs) and other health information technology (IT) tools.  Technology not only changes the way clinicians manage patient care, but also creates new patient care issues to manage.  Other situations prompted by health IT and prone to liability issues include: 

1. New ways physicians manage population health
2. Access to previously unavailable patient information through the use of health information exchange (HIE)

EMRs have been shown to improve patient care and patient safety which will hopefully serve as a strong counterbalance to any new liability risks.  However, if medical liability insurance companies discover a need to raise premiums on physicians who adopt health IT tools, then there needs to be open dialogue over who pays for the increase.  Any rise in liability premiums due to health IT adoption needs to be shared by all stakeholders (liability insurance companies, health plans, consumers, employers, hospitals, government, etc...) and not just the doctors.  The rule of thumb for health IT adoption is that, since it is for the public good, all stakeholders get to play and all stakeholders have to pay

See Live Streaming Video of Bipartisan Meeting on Health Reform Thursday, February 25, 2010, 10:00AM EST

Return here on February 25th, 2010 at 10:00am EST for live streaming video coverage of the bipartisan discussion on health reform.  Listen for issues where health information technology provides solutions especially during discussions about quality of care.  A White House website provides more information on this meeting. 

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