Monday, June 20, 2011

Fulfilling the PROMISe

Dr. Larry Weed
A brand new EMR is being rolled out in a midsize hospital. The EMR is exclusively based on touchscreen technology, with devices strategically placed on the floor. It provides concurrent access to medical records for all team members (physicians, nurses, pharmacists, radiologists, dieticians, secretaries) wherever they may be. Patients are also accessing the EMR. They enter their own histories and describe symptoms in detail through the same touchscreen devices. This patient-centered EMR, built by a team of clinicians and technologists working together, is taking a huge step forward in Clinical Decision Support (CDS). Physicians are not only shown differential diagnoses based on what patients and other team members entered into the system, but are also presented with individualized care plans, possible side effects, dosage recommendations and drug-drug-interaction alerts, all referencing evidence available in medical literature. Longitudinal records, test results and narratives are available by problem and by patient, and the response time is never more than half a second between the thousands of screens available. The place is Vermont, and the year is 1970.

Half a century ago, when work on this EMR was taking place, Healthcare IT was on the cutting edge of technology. The Problem Oriented Medical Information System (PROMIS), the brainchild of Dr. Lawrence Weed, was pushing the envelope on every technology from hardware to operating systems, to network communications, database design and programming languages. By the time this government funded project was finally shut down, the PROMIS team dealt with such issues as mass storage, federated or single database, high availability, human interface design and networking between geographically dispersed locations. It will take several decades for the rest of the world to catch up with Dr. Weed’s, now defunct, innovation and produce something like IBM’s Watson software package, which is yet to be adapted and tested in health care. Somewhere, somehow, we took a wrong turn in Healthcare IT, and it wasn’t the much maligned billing influence, since PROMIS from day one, attempted to integrate billing in its software, with no ill effects.

But something of that brilliant era did survive. PROMIS was essentially an early attempt to computerize the Problem Oriented Medical Record (POMR) proposed by Dr. Weed in 1964, which is almost exclusively used today in clinical documentation, and better known as the ubiquitous SOAP note (Subjective-Objective-Assessment-Plan). Practically every EHR in existence today is based on Dr. Lawrence Weed’s SOAP note format. Whether small or large, client-server or browser, free text or all template based, once you open the encounter note, you are presented with the familiar structure of History of Present Illness (HPI), followed by Social, Medical and Family Histories, Review of Systems (ROS), Exam, Assessment and Plan. Since this is perceived to be the heart of the EHR you will find much “innovation” and “secret sauce” added to the electronic SOAP note, with the singular purpose of speeding up documentation and ensuring that the finished note is a proper clinical, legal and financial document. And as most of us know only too well, we are not there yet.

Interestingly, the folks working on PROMIS faced the same hurdles we are facing today, albeit their tools and technologies were pretty much stone-age compared to present day technology. It is fascinating to see how much effort and concern went into selecting just the right user interface, ensuring that response time was measured in fractions of a second and in keeping the system up 24x7 and as error free as possible. For the clinical staff that took the time to enter data through the state of the art user interface of a  Cathode Ray Tube (CRT) monitor with little touch-sensitive strips attached in just the right places, PROMIS delivered serious value. It offered differential diagnoses for each problem, patient specific care plans, collaboration and real time access to medical records. It obviously wasn’t enough though, since the project did get canceled in the early eighties. Today’s EHRs can, and do, offer collaboration and real time access to records much more efficiently then PROMIS ever dreamed possible. However, only very few EHRs are capable of coming up with differentials, and care plans consist mostly of order sets that you can create yourself (if you wish). As to efficiency of data entry and pertinent information retrieval, we are only slightly better off than the PROMIS pioneer users were. You would expect that every EHR vendor, big and small, would be feverishly working on exactly these problems, trying to bring more value to their customers and differentiate themselves in a crowded market. Well, they were, until very recently.

As Meaningful Use is pushing, shoving, enticing and coercing everybody, by any means necessary, to abandon paper medical records and adopt EHRs, it is also redefining the nature and construct of those records and it is imposing a new set of priorities on all EHR builders. Meaningful Use is about collecting certain data and moving all data out of the originating system to all sorts of other systems, including patients, care providers, governments and other facilities, and more than anything else, Meaningful Use is about measuring clinical quality or lack thereof. There are 113 clinical quality measures proposed for Meaningful Use Stage 2 and there are 65 measures in the Accountable Care Organization (ACO) proposal, which Meaningful Use is also endeavoring to support. Although users are only required to report on a handful of measures for now, those who build decent EHRs must write code for all measures, and this is not a simple thing, since a single measure can require complex computations over many data elements which may or may not even exist in the software. Add to this the remaining Meaningful Use measures and you have a big problem, amplified by orders of magnitude due to the very short timelines between publications of new mandatory requirements. The result is that there are no development cycles left for such things as enhancing user experience, or adding features that customers routinely ask for. Granted, Meaningful Use is considering taking on usability of EHRs as well, but at least initially, this will be through the narrow lens of patient safety, and not so much related to direct value to the actual paying customer.

Are we then doomed to repeat the PROMIS disappointment on a grander scale because the value to the customer is not readily recognizable? Not quite. The differences between our effort to computerize medical records and those led by Dr. Weed forty years ago are many, and none is larger than the fact that today’s copiously funded campaign for EHR adoption is firmly anchored in a much larger effort to change the health care delivery system as a whole (for better or worse). While Dr. Weed was experimenting in one remote hospital, today we are moving full steam ahead on a national level in thousands of hospitals with hundreds of thousands of physicians in both hospital and ambulatory practice, and the point of no return (to paper) has been passed a long time ago. We do however run the risk of making the entire process unnecessarily painful, slow, expensive and fraught with unintended consequences, if we continue to prioritize the political needs of the project itself above and beyond the needs of the customer.

Thursday, June 9, 2011

Meaningful Use Stage 2 – Horses, Camels & Signals

On June 8, the HIT Policy Committee at ONC has approved the Workgroup recommendations for Meaningful Use Stage 2. Before diving into the details, it is worth noting that the time crunch for moving from Stage 1 to Stage 2, for those seeking incentives in 2011, was proposed to be resolved by postponing Stage 2 for these early adopters for one year. As I noted before, if you are able to attest and obtain incentives in 2011, go ahead and do that. You will be rewarded by having the opportunity to stay at Stage 1 for 3 consecutive years. The final Stage 2 ruling is not expected to occur until June 2012 and judging by previous experience with Stage 1, the recommendations approved today will be significantly relaxed by the CMS process of proposed rulemaking and public comments. So although analyzing (rejoicing or bemoaning) the various measures on this long list is a bit premature, it may be helpful to look at the general principles embedded in this new stage of Meaningful Use.

Horses

Many of the Meaningful Use more pedestrian measures have remained unchanged, have increased in intensity, or have been moved from menu to core (more on this later). These measures include such items as recording patient demographics, maintaining medications, allergies and problem lists, recording of vitals, running reports, electronic prescribing, incorporating structured lab results, medications reconciliation, using formularies, enabling clinical decision support, reporting to state and federal agencies and ensuring privacy and security of medical records.

Other measures were slightly expanded in scope. CPOE, for example, was restricted to medications in Stage 1. Stage 2 is adding laboratory orders and capability for radiology ordering. While Stage 1 required that physicians send clinical reminder notices to young children and the elderly, the current proposal is to send those reminders to at least 10% of all patients, and patient education materials which were required “if appropriate”, are also extended to all patients in Stage 2. If you were not a hypochondriac before, you will be encouraged to become one in the near future. The requirement to document the existence of advance directives, which was limited to hospitals, is now also applied to physicians of all types. To even the burden, electronic prescribing, a strictly ambulatory measure, will now be required for 25% of hospital discharges.

And then there are several benign brand new measures:
  • Both office visits and hospital days are required to have electronic clinical notes (30%). The measure is not very prescriptive on what constitutes a note other than forbidding scanned documents and requiring that notes should be searchable.  I can’t wait to see the certification test for “searchable”. It seems the committee is not aware that with very few and limited exceptions, EHRs are not very much like Google. This new measure ought to single handedly disqualify 99% of currently certified EHRs. The searchable part will probably be dropped during rule making.
  • For hospitals, use of an electronic Medication Administration Record (eMAR) will be required in at least one department.
  • Physician practices will need to record patient preferences for methods of communications, but hospitals strangely don’t need to do the same.
  • There will be new clinical quality measures added to the current list to choose from, but this item alone warrants its own separate dissertation.
Camels

As one of the committee members astutely remarked, along with the horses a few camels are also being created by this proposal. Hopefully, most of these creatures will be reshaped and/or eliminated in the final rule, but right now here are the problematic recommendations:
  • No menu items – Stage 1 allowed hospitals and clinicians some freedom in choosing which measures best apply to their situation. While 15 measures were mandatory (core), physicians and hospitals were free to select 5 additional measures from a menu of 10 choices. Meaningful Use Stage 2 is an all or nothing proposition.
  • Hospital labs should send structured electronic clinical lab results to outpatient providers for at least 40% of electronic orders received – This particular triple humped camel elicited much discussion in the committee and exclusions may be provided for small hospitals. Considering that the overwhelming majority of hospitals, small and large, are not currently capable of receiving electronic orders, a fact that seemed to have escaped the committee, this measure amounts to pretty much nothing, since 40% of zero is still zero. It remains to be seen how many of the few hospital labs that can currently receive electronic lab orders will turn that capability off just to escape this particular requirement. Bi-directional lab interfaces are not without cost to build and maintain.
  • Measures to be fulfilled by patients – There are two types of measures that hold providers accountable for patients viewing medical records online (10%) and for patients sending electronic communications to physicians (25 individuals). It is not clear who the messages should be sent to, but Meaningful Use is applicable to clinicians individually. I guess, practices and hospitals can make medical records available online and advertise the ability to communicate electronically, and hope that enough patients take advantage of that. Since we are dealing with all or nothing Meaningful Use compliance, it is more likely that patients will discover one more step in the check-in process – logging into the portal. The other issue here is that while certifying for Stage 1 Meaningful Use, many small vendors utilized third party PHR products (usually Microsoft HealthVault) to make medical records available to patients automatically. These vendors have no patient portals and no way to verify that patients actually viewed their medical records, without asking the patient to be kind enough and send in a copy of their PHR utilization reports.
  • For care transitions, summary of care and care plan are sent electronically to receiving facility or physician, and care team members’ list is available for electronic exchange – This was probably the most debated set of measures and the results as they appear in the proposal are difficult on many levels. First and foremost, the care plan in Stage 2 is envisioned to be just free text attached to the standardized summary of care record. Most advanced EHRs have separate sections, some structured, where care plans are directly documented and/or automatically assembled based on orders. It is not clear how that free text is to be created to satisfy the measure, other than requiring physicians to document the plan a second time. It is also not clear how you hold one party responsible for sending things electronically while it has no control on the abilities of the receiving entities (look for major exclusions here). And it is completely unclear what exactly should be done with that free text list of team members, once it is available, and who should be on it (Other specialists? Hospitalists? Community resources?)
  • The last two new items are just suggestions for CMS to evaluate, and both deal with expanding ambulatory reporting requirements to include syndromic surveillance and cancer reporting. Not sure if there’s anybody out there willing and able to accept such data.
Signals

As expected Meaningful Use Stage 2 is significantly upping the ante for 2013 (or 2014 now), but more importantly, the committee’s recommendations are also “signaling” to the more distant future of Stage 3. Possibly the most frequently used term in workgroup and committee meetings, “signal’ (used both as a noun and a verb) refers to providing hints to users and software vendors, indicative of intended future requirements of Meaningful Use – one if by land, two if by sea. So here are the brightest lanterns shining towards Stage 3:
  • Have nationally endorsed lists of drug-drug-interactions (DDI) and ability to record reason for overriding alert – Your DDI alerts, the ones that you were able to adjust and configure to your liking, will be coming from a federal designated source. Hopefully they will come in the form of friendly advice. Either way, they will want to know why you are overriding things.
  • Second hand smoking status will be added to just plain smoking status, and more refined race and ethnicity data will need to be captured.
  • In Stage 3, EHRs will need to be able to store and retrieve those advance directives, not just indicate that they do or do not exist, which is pretty useless in and of itself.
  • Family History recording will become a requirement as soon as they devise a proper standard for it. Considering that most EHRs already have structured templates for documenting all histories, and most of them are pretty much identical, it would be interesting to see what the new standard will look like and how much rework and data migration will be necessary.
  • That care team field mentioned above will no longer be just free text. National Provider Identifiers (NPI) will be required. It seems that only licensed clinicians can be on a care team.
  • Patient-generated data will be submitted to public health agencies - I am not going to even venture a wild guess regarding this one.
  • Compliance with the Nationwide Health Information Network (NWHIN) governance policies should be included in Stage 3 certification criteria - Here is where the future is beginning to look awfully hazy to me.
If the proposal to extend Meaningful Use Stage 1 through 2013 is accepted by ONC and CMS, and it should be, Stage 3 will most likely be pushed out by one year as well, so these various signals are directed to the year 2016 through heavy fog and precipitation. It is too soon to alarm the country. The most immediate order of business is to smooth those camel backs, and we have an entire year to do just that.

Saturday, June 4, 2011

Coordinating Care Coordination

Care coordination is one of the four pillars of Meaningful Use, one of the six NCQA Patient Centered Medical Home (PCMH) standards and one of the main goals of Accountable Care Organizations (ACO). Care coordination, particularly for patients with multiple chronic conditions, is expected to reduce unnecessary repetition of laboratory testing or imaging and the number of avoidable admissions. Other than reducing overall costs, care coordination is also supposed to improve quality of care. According to experts like Joe Flower, “Lack of care coordination is at the core of the mess healthcare is in”, and nobody in their right mind would argue that it is best that medical care remains disorganized and uncoordinated, if it is indeed so. It seems that our fee-for-service, fragmented and fractured (lots of f-words here) health care system is not conducive to care coordination. When patients float around in a sea of hospitals, physicians, nursing homes and other facilities, each care provider gets paid, and is responsible for the piecework performed at their independent entity and nobody is minding the handoff of patients to the next provider of care, and nobody is assembling a comprehensive picture of the entire care process, let alone orchestrating, or coordinating, the progression of patients between stages of care and the overall needs of patients in transit. What would it take then, to see that the bits and pieces of health care we now have, become a safe and affordable continuum of care?

CMS is taking the lead, as it should, in an all-out effort to encourage health care coordination through various carrot-stick initiatives, aligned to ultimately base payment for medical care on value to the patient, as measured on a population level, instead of fee-for-service and no accountability for outcomes. These initiatives fall into three general categories:
  1. Health Information Technology to assist with documentation, information exchange and measurements as required in any coordination effort.
  2. Incentives and penalties for providers based on measures thought to be influenced by care coordination (e.g. preventable hospitalizations, readmission rates, etc.)
  3. Financial and structural encouragement for vertical integration of the delivery system (e.g. ACOs, consolidation, employed physicians, etc.)
Of all three categories, only Health Information Technology (HIT) is foundational.  HIT is supposed to provide a toolbox for simplifying and even automating many of the tasks associated with coordination of care. The other two categories are based on series of assumptions, hope, belief and lots of other magical thinking. A brief scan of Meaningful Use regulations, which is quickly becoming prerequisite to both PCMH and ACO, reveals the following proposed care coordination enhancing features:
  • Health Information Exchange (HIE) – To paraphrase the quality measurement mantra, you cannot coordinate that which you don’t know. Most care coordination efforts today are based on faxes, phone calls and using the patient as courier for paper based artifacts. If there is one thing that computers excel at, it must be timely exchange of information. Aggregating and placing complete health information at the fingertips of all clinicians, in real time and with minimal loss of fidelity, would in and of itself eliminate most effects of geographical and organizational diversity and fluidity of care providers for any given patient. Most, if not all, remaining features are just elaborations on the information that needs to be exchanged, the actions to be taken following the exchange and the tracking of both the actual exchange and the activities surrounding such exchange. 
  • Planning Care – Care plans are not a new idea, but now they will have to be composed with patient participation, and shared between physicians, hospitals and other care givers. The vision is to eventually have one collaborative plan of care accessible to all involved.
  • Managing Transitions of Care – Here you find the multitude of documents to be shared when care is transferred between facilities and/or physicians. There are care summaries, discharge notes and instructions, medication lists that need to be reconciled, and the PCMH standard adds careful tracking of referrals, appointments, test results and consultation notes.
  • Measuring Results – Meaningful Use lists 48 clinical quality measures, and more are being developed, ranging from weight measurement and dietary counseling to inpatient medication administration. At this point, this is mostly about measuring care process metrics.
What we have here is nothing more than classic Project Management: Planning, Collaboration, Change Management and Measuring. The project is health and the project owner is the patient. There are millions of such small projects executing every day around the country. In the current system, many are executing with no project management. Sometimes the owner assumes the role of project manager, sometimes a conscientious primary care physician takes on that role, but most often we all step in and out of a management role as the project heats up during events such as birth, acute disease or trauma, chronic disease diagnosis and terminal illness.  Most of us, including physicians, have no resources, no training and no decent tools to manage our health projects. In the business world, professional project management is part of every (successful) project, with purpose built tools and adequate budget allocations for this coordinating function.

Perhaps this realization is the main driver behind the expert advocated, and government endorsed push to consolidate health care into large business entities. The viewing resolution from Washington, and from equally removed academic departments, renders all our pixel-size individual health projects indistinguishable from each other in the large picture of population health. This is one case where the forest is obscuring the trees. So with the best of intentions, the government is proposing to create a handful of Project Management Offices (PMO), which is what ACOs really are, and make them fiscally accountable for operational profit and loss (P&L) at a population level. Instead of dealing with hundreds of thousands of small contractors, the government will be stepping into its familiar role of contracting with large corporations as the prime contractors for goods and services. These prime contractors, similar to their counterparts in the defense industry, will be at liberty to subcontract with smaller entities or employ their own resources, and together they will completely dominate all aspects of the market.

This massive reengineering of the health care delivery system is deemed necessary in order to begin eliminating the excesses and fragmentation brought on by the centuries old fee-for-service model of medicine. But if we learned one lesson from the fee-for-service model, we certainly learned that if we pay by the yard, we get more yards. So common sense begs the following question: if we want more care coordination, why not pay for care coordination (by the yard)? Unlike quality of care and outcomes, care coordination processes are easy to define, easy to measure and widely understood by all stakeholders. If CMS could define a set of CPTs for Evaluation & Management which entail counting all body parts being examined and accounting for all diseased relatives, couldn’t it define a set of Coordination CPTs to track care planning, exchange of care summaries, referrals, results, instructions and whatever else is deemed to contribute to care coordination?  Computers, HIT and the Internet are greatly enabling these activities, both inside and across organizations of all sizes, and are automating their documentation in the medical record. If physicians and hospitals were allowed to bill these Coordination CPTs at various levels for each encounter, and they were paid at attractive rates, we would see a flurry of activities leading to HIT adoption, health information exchange, collaboration and ultimately coordination of care.

Paying for care coordination on a fee-for-service basis will allow a unified definition of services and individual customization per patient. Some patients will need more, others will need less, and different people will need different coordination services at various times. Unlike a capitated fixed fee per patient per month, there will be no temptation to skimp on services and it is really hard to argue that too much coordination is even possible. Indirectly paying for a finished product, such as paying for outcomes, is very difficult in health care since the product is only finished when we are dead, and retrospective measurement of expenditures for dead people is nothing more than crying over spilled milk. If we maintain the granular fee-for-service system of levers, we can recoup coordination expenses by carefully reducing payments here and there for services we want less of.
So instead of punishing hospitals for failing to coordinate care, instead of penalizing doctors for lack of technology, instead of incenting everybody to do the right thing in roundabout ways, and instead of faith-based reengineering of the entire system from the top down, why not try to achieve our goals the American way, by paying a fair fee for an honest service?