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 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.

Keep the data collection cart behind the trailblazing horse

In today's Health IT News there is an article expressing dissappointment with the recently released proposed rules for Stage 2 of the Electronic Health Record (EHR) Incentive Program.   Some alarming viewpoints are evident in this article regarding the collection of data for use by the federal government to improve public health .

The proposed rule for Meaningful Use Stage 2 on page 13702-13703 specifically states that the purpose of Stage 2 Meaningful use is to "“encourage the use of health IT for continuous quality improvement at the point of care and the exchange of information in the most structured format possible”.    No where in the rule does it state that the primary purpose of Stage 2 Meaningful Use is to collect data for use by the federal government as is suggested by concerns expressed in this article.   Let's keep the data collection cart behind the trailblazing horse so that it does not aimlessly roll down the steepest part of the hill instead of steering toward most beneficial path.   Stage 2 objectives draw a sensible roadmap to the next planned destination where we can finally begin realizing the maximum potential value of health IT and EHRs.   We currently have the horse trotting around potholes toward the widespread adoption and successful use of EHRs, the development of robust HIE networks, the maturation of EHR product functionalities and an improved understanding of safe EHR usage.   If we fail to align Stage 2 activities with Stage 2 goals by taking unplanned shortcuts to collect and use data in hopes of improving care now, I fear the cart will crash and cripple the momentum that Stage 1 has initiated.

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.

Health Information Exchanges and Physicians Share Accountability for Safe Patient Care

The $800 billion 2009 American Recovery and Reinvestment Act (ARRA) set aside $36 billion toward health information technology (health IT) initiatives, including over $500 million for the State HIE Cooperative Program.  This federal program provides funds to each state for the successful planning and development of infrastructure that supports the exchange of electronic health data between physician electronic health records (EHRs), hospital EHRs, lab systems, radiology centers and other clinical IT systems.    For example, in Texas we are using these funds to support the development of local health information exchange entities, called HIEs, across the state and to concurrently develop the policies, standards and infrastructure needed to safely/securely connect these HIEs to each other.     The statewide HIE network will also be built to be compatible with national standards and efforts.      

Each state's effort to develop a network of community HIEs and/or a statewide HIE will be more successful with physicians involved upfront with governance and policy development.   When working with local HIEs most physicians will generally understand and appreciate the importance of protecting the privacy and security of electronic patient health information.  Their inherent knowledge on this issue will help guide policies in the right direction.   A more complex issue for physicians to understand is the relationship between HIEs and patient care.   A heightened awareness of this issue will allow physicians to properly inform HIE policymakers about the need to establish an environment where local HIEs, HIE networks and physicians share accountability for safe patient care.   

To deepen physician's understanding of this issue I encourage them and others to think about an HIE as a tool physicians use as a part of patient care, similar to a surgical tool.   If a patient is harmed by a surgical tool that broke because the physician used it incorrectly, the physician is negligent.  If the physician used the tool correctly but it still broke, but it has only broken 8 times in over 10,000 surgeries and the patient consent explains this remote risk of breakage, then no one is negligent.  However, if it broke and the issue had been reported to the vendor by many physicians on a repetitive basis, but the vendor failed to investigate the issue and fix the problem, or failed to inform physicians and patients of the increased risk in the meantime, then the vendor is negligent. 

This perpsective will help physicians advocate for policies that lead to an environment where HIEs and physicians share accountability for safe patient care.   Effective policies will lead to contracts and agreements which acknowledge that:

  1. HIEs and HIE infrastructure are tools used by physicians during the course of patient care
  2. HIEs are responsible for informing patients and doctors about the inherent risks of  the electronic health information exchange including changes in risks when issues are identified
  3. HIEs have a responsibility to continually monitor for and mitigate risks associated with their services that may impact quality of care provided by physicians


Bipartisan Health IT Support and ARRA Insulate EHR Incentive Funds From Budget Cuts

A physician colleague recently asked me why I am confident that CMS will not cut off EHR incentive funding in the future.   This question is important to him and other physicians who plan to qualify for up to $44,000 in CMS incentive payments by achieving the meaningful use of EHRs.   They fear that the dragging economy and political discord will result in budget reductions that will cut this and other important health IT funding programs.    What I see, though, is a decade-long track record of bipartisan support for health IT initiatives and a 2009 federal law that requires CMS to provide funding for the EHR incentives and other health IT programs.

In his 2004 State of the Union speech President Bush envisioned the adoption of EHRs for all Americans by 2014.   Since then bipartisan support at both the state and federal levels for health IT initiatives toward the achievement of that vision has held strong.   At the federal level CMS  not only established a new office in 2004 to support health IT, the Office of the National Coordinator of Health IT (ONC) but has also increased funds to support ONC initiatives which promote the adoption and use of EHRs.  CMS works collaboratively with ONC and has consistently shown an understanding that the broad adoption and effective use of EHRs are necessary to better manage spiraling healthcare costs.   CMS understands that the data captured by EHRs is superior to claims-based data when attempting to analyze quality and establish benchmarks.    Physicians have long complained that claims-based data is incomplete and does not fairly demonstrate the quality of care they provide.     EHRs must be broadly adopted in order to capture accurate and meaningful data that can then be used to improve quality or save costs.  

It is important to recognize that CMS is required to provide EHR incentives to physicians by law.   Specifically, the $800 billion American Recovery and Reinvestment Act (ARRA) of 2009, commonly refered to as the Stimulus Bill, allocates over $36 billion to health IT programs through the Health Information Technology for Economic and Clinical Health (HITECH) Act.   This funding includes an estimated $34 billion for the Medicare and Medicaid EHR Incentive Program and over $300 million to support state-wide health information exchange efforts.

In order to cut funding for EHR incentives, this means that bipartisan support would have to be garnered in the House and Senate to rescind ARRA or part of ARRA.   The intent of ARRA  initiatives is to stimulate economic activity and produce jobs.   In the current economic environment it would seem very risky, perhaps even foolish, for a politician to drum up support for new legislation that eliminates economic stimulus activity, especially if that activity is already producing jobs.

So, is the EHR Incentive Program stimulating the economy and producing good jobs?   I am not an economic expert, but from what I see around me the answer is clearly, "yes".    I see job openings in the local paper for healthcare system IT analysts and other staff, I speak with IT consultants most of whom are actively seeking personnel, I hear about physician offices investing into the economy $10,000-$70,000/doctor to implement EHRs or upgrade other office technologies, I read about physicians receiving $44,000 federal incentive payments and about hospitals receiving larger amounts, some of which is surely returned into local economies.  The graph below is a composite view of the 3-year stock performance of the health IT sector since 2009.   EHR vendors and other health IT companies appear to be thriving well since ARRA was passed despite the depressed economy.

HIT Sector performance

I suspect that several years from now when experts analyze the impact of the $800 billion stimulus package, the puny $36 billion provided to health IT initiatives through the HITECH portion of ARRA will go down as perhaps the most bang for the buck in terms of stimulating the economy.  

The EHR incentive funds appeared to be well insultated from budget cuts for these same reasons. 

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.

High Demand Persists for Chief Medical Information Officer (CMIO) and Health IT Physician Champion Roles

Physicians with health information technology (HIT) implementation experience are in high demand for a variety of roles in organizations that are implementing clinical IT systems such as electronic medical records (EMRs).  The roles and responsibilities of these physicians has been evolving and growing.  IT physicians in the early 1970s typically served as clinical "subject matter experts" to ensure that clinician's needs were identified and met by IT projects.  In the 1990s the need for IT physicians increased as more hospitals implemented clinical IT systems.  Throughout the 1990s a series of studies on the high prevalence of medication errors and the ability of HIT tools to reduce these errors culminated in the 1999 Institute of Medicine report, "To Err is Human".  This led to external pressure on hospitals to more aggressively pursue implementations of more advanced clinical technology tools such as electronic medication administration records and computerized physician order entry (CPOE).  Some of these implementations failed and others experienced sub-optimal results.  Strong clinical leadership, management and oversight at the executive level became recognized as a key factors in successful implementations.  The project-oriented, physician liaison role was still needed but no longer sufficient.  A new generation of IT physician leaders, the Chief Medical Information Officers (CMIOs), have been added to a majority of hospital executive staffs to meet these leadership needs.    

The increase in complexity of EMR implementations is due to the development of HIT products that provide more advanced functionalities and more configuration options for users to evaluate and implement.  This increase in the number of functionalities available creates more work to do during the design, build and testing of the systems. More importantly, the advanced clinical IT tools such as CPOE impact a greater number of direct clinical care processes including the daily work flows for patients, nurses and doctors.  These changes to processes and work flows cross over cultural boundaries in a way that organizations have not previously experienced.  The transformational effort needed to overcome these cultural boundaries requires strong clinical leadership, communication skill, consensus-building skill, political maneuverability, strategic thinking, adaptablility, strong interpersonal skills and sensitivity to the organization's nuances and uniqueness. These skills describe some of the ideal characteristics of today's CMIOs.

It is important to reiterate that physician champions who are clinical "subject matter experts" remain in high demand for clinical implementations in addition to the CMIO.  These physicians essentially become part of an informatics team with the CMIO.  Even in small organizations it is obviously not possible for the CMIO to be the subject matter expert for every clinician for every clinical project. The CMIO can, however, be the catalyst to get the right amount of clinician participation with the right clinical expertise into clinical IT projects. The CMIO can facilitate the redesign of hospital committee structures and roles to ensure ongoing support and governance of a new EMR.  To be effective, then, the experienced CMIO manages time by differentiating between situations that require their expertise through close, detailed involvement from other situations that are best managed as a facilitator, educator or mentor. 

The value of a multidisciplinary informatics team with physician, nursing and other clinical liaison members is recognized by organizations.  Organizations today should therefore consider planning for a multidisciplinary informatics team not just for their initial major clinical implementations, but also for ongoing optimization and support of these expensive systems.  This group is the source for clinical "subject matter expertise" during IT implementations.  After the implementation this group of clinicians becomes an invaluable resource for the continual optimization and support of clinical technologies.  Some members, such as the physician champions, will not need to spend as much time with the informatics team post-implementation, but their experience and expertise will be tapped into.  Some hospitals have decided to attract physicians to this role by creating an inpatient Medical Director for the EMR / Computerized Physician Order Entry (CPOE) and an outpatient Medical Director of Ambulatory EMRs for their physician offices.  Some are full-time positions and others are part-time, dependent on the size of the organization, and they work closely with or report to the CMIO.   

The early physician IT champion role of the 1970s evolved into an executive level CMIO role as clinical technologies became more advanced, more costly and more complex to implement.  CMIO positions have subsequently become common within hospital organizations.  Physician champions, however, also remain in demand as clinical "subject matter experts" for their clinical IT systems.  As organizations continue to implement, upgrade, optimize and support their  expensive clinical IT systems, CMIOs and clinical IT liaisons including physicians, nurses, lab technicians and pharmacists will remain in high demand.