HIT: Challenges from the Data Perspective

Patient health and medical information generated in a healthcare organization can be categorized by various features. For example, it can be

• Transactional, related to a separate event, such as an ADT, exam, order, procedure and so on
• Summary, describing the development and status of a condition, family and social history, providing a problem and medication list, etc.

From the vocabulary interoperability standpoint, each piece of information is either coded or uncoded. Coded entries, e.g., diagnoses, always contain the code value from a coding system and the name of the system, as in the following excerpt from a CCD:

<observation classCode="COND" moodCode="EVN">
  <id root="abbbdd09-ae9f-4879-aa80-3893736973d1" />
  <code code="346.2" displayName="Migraine Headache, Variant" codeSystem="2.16.840.1.113883.6.103" codeSystemName="ICD9CM" />
</observation>

Uncoded data is usually a narrative in a free text form, for instance:

DISCHARGE DIAGNOSES
Extruded disk, L4-5, with right L4 and L5 radiculopathy.

From the semantic interoperability and automatic processing point of view, each record can be structured or unstructured. HL7, CCR and CCD-formatted data are good examples of structured records. Images, scanned and text documents represent unstructured ones. Be aware, though, that structured records may, and often do include unstructured pieces. For instance, an HL7 message can contain a free-text report or note.

The rationale behind the HITECH Act and Meaningful Use was not as much about lack of patient information, as about its availability (with privacy and security protection, of course) and usability. Computer programs are very good at categorizing, grouping and sorting electronic records as long as the logical model of the data includes standard codes for diagnoses, medications, problems, etc., and links labs, reports and clinical documents to respective encounters. The challenge though, is to get all these attributes populated.

The Stage 1 Criteria for Meaningful Use make a serious effort towards improved usability by requiring recording patient demographics, problem lists, current and active diagnoses, medications and medication allergy lists and lab test results as structured and largely coded entries. It seems relatively straightforward with regard to patient demographics, diagnoses, problems lists and electronic prescriptions, even though, for example, very few if any EHR systems use the CDC Race and Ethnicity Code Set. The HIT Certification programs together with the Meaningful Use Criteria will eventually encourage EHR system vendors and users to implement standard vocabularies, especially, since the Unified Medical Language System (UMLS) is now available at no charge in the U.S. Interestingly enough, there are no similar requirements for lab systems. The hope is that healthcare providers trying to become meaningful users will gradually steer clinical labs in the same direction. But for now we can expect a lot of activity building and customizing integration interfaces to get lab test results structured, UCUM-normalized and standardized.

The move towards structured and coded EHR will be a huge deal even just going forward. There is an enormous volume of historic data, some of which has not yet been digitized at all. It has to be dealt with in a smart fashion, based on record holders priorities and resources. But this topic deserves a separate discussion.

HEALTH IT: GOALS, CONCERNS AND CHOICES

Health information technology, if properly implemented, can move us closer toward two fundamental goals of healthcare reform:

• Improved quality of care, through:
  * Making comprehensive patient information (clinical history, medications, test results, etc.) available at the point of care
  * Better decision support
  * Patient involvement
• Cost containment, through:
  * Prevention of errors; elimination of duplicate tests and treatment procedures
  * Faster dissemination of research results and best practices

From the provider standpoint, there are three logical levels of information aggregation. First, all pieces of medical data for the current encounter (complaint, diagnosis, tests, reports, notes, medications, treatment procedures) are combined with relatively static patient’s personal information (demographic, family history, social history), into a visit summary. At the next level, the entire visit history for that patient at this point of care is incorporated. Finally, all patient records from all source EHR systems are added together to form PHR.

In fact, the first and second levels of aggregation can be found in most EHR applications. There is still work ahead of us to simplify and automate communication between them and, for example, lab or bedside monitoring systems. Eventually, that will depend on the architecture of each EHR system, and is not going to be covered by interoperability standards. This means that the internal representation of patient data, the way it is stored, delivered and presented to the user, is up to the system vendor. Luckily, that is largely a technical task of establishing necessary protocols and data exchange formats.

It gets more complicated when we need to retrieve patient records created by another EHR system outside of our network. Basically, it does not matter if it is two blocks away or across the country, from a birds’-eye perspective, the process will look the same: to locate those records; send a request; get results. At a closer look, though, each of those steps has a number of actions involved, and architectural decisions have far-reaching implications.

For an EHR system, the capability to find external health records for a patient depends on access to a registry that links an identifier, which must be unique for each person, with all repositories where those records are stored. It either has to know that identifier, or should be able to get it based on the patient data it has. Basically, there are two choices: a nationwide patient number, which will be assigned at birth or on arrival to the U.S. with a proof of residence, or a Record Locator Service (RLS), that is to create a unique master index for every person and to tag all records for that person with it. The main objective against the nationwide identifier is that without proper identity verification process, it may be abused, much like SSN is, to gain access to somebody else’s medical records. As for RLS, it brings a few mostly technical issues. In general terms, it uses record matching techniques based on demographic information available in EHR. If certain fields are empty or contain incorrect values, they may return false positives or negatives.

The record retrieval process can also differ depending where the data is stored. If there is a centralized repository, containing copies of all medical records, it is relatively straightforward. The data management application

1. Authenticates the user (checks his credentials)
2. Authorizes him (grants access rights) based on his profile
3. Applies privacy protection rules (laws, regulations, patient consent instructions)
4. Formats results and sends them back to the requester
5. Creates audit records (who, what, when)

The most complex part of the workflow logic corresponds to steps 2 and 3. For example, an ED doctor requests health records on the out-of-state patient he currently cares for. If the state of residence has different disclosure rules than the one the patient is being treated in, which of them should apply? Should the doctor be allowed to see psychiatric records if the patient has apparent congestive heart failure?

Maintaining profiles of external users and implementing all that logic may prove too overwhelming for an individual EHR system in a pure P2P world. It makes a lot of sense to set up an intermediary that will handle most of that process. Each connected EHR system will only need to know a limited number of user categories, and what information has to be provided depending on which category the requesting user belongs to. In this framework, though, the big unknown is availability of source EHR systems, especially, in small hospitals and practices. Storing a copy of patient records at a local RHIO, much like in the centralized repository, will insulate the source EHR system from external requests, but the need for a record linking mechanism will still remain.

As far as clinical research and public health activities are concerned, where data mining and statistical analysis are applied against large volumes of data, a centralized repository of personal health records is the most efficient and, perhaps, secure option. Traditionally, researches receive anonymized, or de-identified, patient data directly from healthcare institutions. HIPAA allows for disclosure of de-identified records, but in a recently published paper, Paul Ohm of the University of Colorado Law School states that release of raw data does not guarantee necessary privacy protection, especially, if the data enters the public domain. In many cases, though, the end result of interest is computed statistics, bearing no links whatsoever with any personal information. By keeping data inside the repository, controlling and monitoring access to it, we have a better chance to avoid unintended consequences.

I tend to believe that there is no ideal architecture or technology that could perfectly meet all our needs, and personal health records are no exception. The law, policies and standards will continue developing, hopefully, with the goals, that I mentioned earlier, in sight.

HEALTHCARE REFORM: ARE WE LOOKING IN THE RIGHT DIRECTION?

There is an ongoing discussion whether our healthcare system is or is not the best in the world. Those, who say it is, refer to the fact that thousands of patients from around the world come to the U.S. for treatment. According to the Deloitte Center for Health Solutions, "In 2008, more than 400,000 non-U.S. residents will seek care in the United States and spend almost $5 billion for health services… Most come for a medical or surgical specialty program requiring hospital-based care." No doubt, our leading hospitals and clinics provide high-tech facilities and unmatched professional expertise. At the same time, compared to the other OECD countries on the basic health status indicators, such as life expectancy at birth, premature and infant mortality, as well as on healthcare expenditures per capita, we clearly overpay for mediocre results. Apparently, we are entering the stage of diminishing return in healthcare.

We all agree on the goals of healthcare reform:

• Covering the uninsured
  
• Improving quality of care
  
• Cost containment
  

According to the Economic Policy Institute,
in 2008, 58.5% of Americans were enrolled in an employer-sponsored health insurance plan, 8.9% purchased individual private insurance, 29% had public plan coverage, and 15.4% were uninsured.

In most cases, insurance plans, offered by employers, effectively insulate insureds from medical bills, except for co-pay and deductible, which are usually relatively low. So it comes at no surprise that 75% of policyholders are satisfied with the coverage they have. The problem is though, that rapidly rising costs of insurance for both companies and employees create a vicious cycle. On the one hand, in order to keep budget in check employers try to lower their contribution, cut benefits, or switch to high deductible plans. That makes employer-sponsored insurance even less attractive for younger and healthy employees, who normally pay higher percentage of their salary or wages in premiums than their older co-workers. If they opt-out of the plan the pool becomes smaller and riskier for the insurer and more expensive for the remaining participants. The same happens on a larger scale when some employers stop offering health insurance altogether. "Watered down" benefits increase the ranks of underinsured patients, who pay at least 10% of their income on medical bills, excluding premiums. It seems extremely unlikely that we will be able to extend coverage to the uninsured through individual mandate and subsidies for low-income Americans in the current environment without additional federal spending.

There is a popular perception that a large portion of healthcare expenses, especially, uncompensated for providers, is associated with the use of ED facilities by the uninsured Americans or illegal aliens. In June 2006, though, Health Affairs published an article that links higher use with age, health status and income, rather than with lack of insurance or legal resident status. If its conclusions are correct we can hardly expect any real savings on ED services by covering the uninsured.

What actually makes our healthcare so expensive?

In his testimony to the Senate Committee on Health, Education, Labor and Pensions, Dr. Dean Ornish, President of Preventive Medicine Research Institute, said that "…Heart disease, diabetes, prostate/breast cancer, and obesity account for 75% of health care costs, and yet these are largely preventable and even reversible by an integrative medicine program of comprehensive lifestyle changes." Most of us, unfortunately, find it too hard to change our habits, and instead rely on a "magic pill" that should fix problems our body develops over years of neglect. Actually, few use free or deeply discounted wellness programs and regular screening available through their insurance.

Some studies suggest that our healthcare system has become over-specialized, with primary care being marginalized, largely due to income disparity between specialists and primary care physicians. The Medicare fee schedule, often mimicked by private insurers, favors hi-tech diagnostic and treatment procedures, with little regard to their value or outcomes. The share of capitation payments is down even in primary care, whereas evidence-based payment systems, such as PROMETHEUS, do not seem to be quite ready yet for wide adoption.

The fee-for-service payment model, basically, shifts providers' focus from patient's health to selling more services and does little to promote care coordination and information sharing. The Dartmouth Atlas found no evidence that greater supply of resources and higher utilization improve access to care and its outcomes.

The pharmaceutical industry remains the most active lobbying force in Washington in its bid to prevent the government from obtaining the power to negotiate prescription drug prices under Medicare, maintain the existing inventor's protection regulations for "traditional" pharmaceutical products and make them more stringent for biologics. Despite slowing growth in spending on prescription drugs over the last eight years, which is mostly attributed to wider use of generics, the pharmaceutical sector is still exceptionally profitable. Besides, it may even benefit from the push to control healthcare spending, by replacing advanced surgical procedures with more conservative treatment.

Getting back to our first goal of covering the uninsured, any solution currently discussed requires additional funds, at least, to assist those who cannot afford it now. There is no way around that, but this is what has to be done anyway.

As far as two other goals are concerned, we should shift our focus from treating specific conditions to improving health status of patients. With this in mind, we may need to develop a "health score" or set of measures to gauge the overall physical health of an individual, and which will be based on more than just vital signs. The matrix of indicators could be populated at regular check-ups and hospital admissions and discharges. This would give both the patient and medical team an idea where the body needs attention the most and help work out a treatment plan and targeted wellness program. Measuring outcomes will be easier, but the trick is to get patients to follow the recommendations, especially, when we talk about prevention and chronic disease management in ambulatory settings. The "market way" is to encourage good and penalize bad behavior through cost sharing; with a single payer there could be different incentives. This may work for some of us; others may have to be policed. And, of course, a lot needs to be done to promote healthy living through education and mass media campaigns to make it "cool", at least, to our children.

HEALTHCARE REFORM: A BALANCING ACT

There are clear signals from Capitol Hill, which suggest that the idea of public healthcare is unlikely to gain traction in either chamber of Congress. Proposals in the works are aimed at preserving the existing market framework, while making health insurance more affordable, covering patients with pre-existing conditions and curbing healthcare spending. Whether the reform is going to work basically depends on how well individual and group interests will be aligned towards maximum efficiency in applying care.

The first, and arguably, most important aspect of any solution is to change the economic environment on the supply side, by drastically reducing use of “fee-for-service” compensation, which generally encourages waste and marginalizes preventive care, and replacing it with value-based reimbursement system. This is supposed to re-focus providers’ attention from selling more services within their domain, to achieving best possible outcomes with fewer resources, in coordination with everyone else involved.

On the supply side, cost sharing is proposed, in the form of higher out-of-pocket expenses and/or deductible. In theory, this should make consumers inclined to take more responsibility of their own health and chose higher-value care when they need it. At the same time, some patients tend to cut back even on necessary services with little regard to their actual value. To mitigate this side effect, patients need to have access to information about their health status and ways to improve it, as well as to be offered incentives for taking good care of themselves. Perhaps, something like a “health score” would help with setting goals and creating a program to achieve them.

In order to be successful in the long run, healthcare reform has to be comprehensive, but to be adopted, it must:
· have support of the most influential stakeholders, not just public at large
· be deficit-neutral during implementation
· have immediate tangible positive effects on a majority of Americans

There is a lot of explaining required from the Administration and Congress, especially on the last two bullet points, to prove that we will have the right treatment for our healthcare.

HOW MEANINGFUL CAN BE “MEANINGFUL USE”?

There are a few major categories of electronic record systems used in modern healthcare:

• Admission-Discharge-Transfer (ADT)
• Scheduling
• Diagnostic and analysis (laboratory, DI, radiology, pathology, etc.)
• Procedure
• Pharmacy/Rx
• Billing
• EHR

As it is with any other information system, their main goal is storing data, simplifying its retrieval and automating its processing to deliver information in the way that makes sense to each user. In most cases, they do a good job increasing efficiency of respective business processes. But their combined effect can be even greater if EHR systems are able to communicate with the others and one another electronically. In my previous post, I mentioned that the capability of an EHR system to interact with Rx applications would decrease the risk of drug allergies and incompatibilities, especially, when the information from available problem and medication lists could be utilized. Another benefit is the ability to use consistent terminology and codes (e.g., SNOMED CT, LOINC, ICD-10) throughout the entire care environment, which would enable much more efficient search and reporting options, especially, at the RHIO and NHIN level. This is what I would expect the Health IT Policy and Standards Committees to concentrate on, when considering definitions of meaningful use of EHR.

WHAT EHR IS ABOUT

Currently, a number of discussions are going on, regarding various aspects of the Electronic Health Record (EHR), including its definition, contents, structure, uses, availability and access control. According to the Health Information Technology American Recovery and Reinvestment Act (Recovery Act) Implementation Plan, published by the Office of the National Coordinator for Health Information Technology, there are two major goals set forth by the Federal Health IT Strategic Plan:

1. Inform Health Care Professionals: Provide critical information to health care professionals to improve the quality of care delivery, reduce errors, and decrease costs.
2. Improve Population Health: Simplify collection, aggregation, and analysis of anonymized health information for use to improve public health and safety.

From my point of view, they translate into:

• Paperless medical offices, including:
  - Computerized Physician Order Entry (CPOE)
  - e-Prescribing
• Continuity of care, meaning:
  - Prevention of duplicate tests and diagnostic procedures
  - Comprehensive medical, family and social history
  - Awareness of allergies and avoidance of adverse drug interactions
• Collection of diagnoses, treatment plans and outcomes, which would enable:
  - Discovery of environmental causes of disproportionally high or low probability of certain diseases among populations
  - Learning about effects of age, race, gender, etc., on the probability to develop a specific condition
  - Biosurveillance; early detection of epidemic outbreaks
  - Evidence-based decision support

Apparently, the items in the second list have little to do with and do not need much of personal information, so patient records can and should be de-identified. This is relatively easy to do as long as EHR data is well structured, and all sections and elements are distinctly separate. HIMSS defines the EHR as “… a longitudinal electronic record of patient health information generated by one or more encounters in any care delivery setting. Included in this information are patient demographics, progress notes, problems, medications, vital signs, past medical history, immunizations, laboratory data and radiology reports.” The Continuity of Care Record (CCR) schema adds advanced directives, family and social history. It provides a format for exchanging patient information between EHR systems and could become one of Health Information Exchange (HIE) interoperability standards. But this is a big topic, which I would like to touch a bit later in a separate post.

The complexity and features of an EHR system definitely depend on the environment it is used in, and will be different for a specialist office, family practice or hospital. But the system has to be able to communicate with other applications that deal with patient data, using standard exchange formats and protocols. This would be the first and most important step towards connected care.

Unfortunately, according to Wikipedia, adoption of EHR systems in the U.S. remains low. Among major reasons, the article mentions high start up and software maintenance costs, reduced productivity during the implementation phase, and, in most cases, lack of measurable gains, especially, for smaller hospitals and clinics. There is an apparent disconnect between potential benefits on the national scale and those for an individual provider or healthcare organization. Market has failed to create incentives for implementation of EHR systems, so the Government had to step in with the HITECH Act. I believe there is a good chance for an open source EHR system, such as OpenVistA, in an ASP model, which may remove most of perceived and real barriers to wider adoption of EHR.

ARE WE READY FOR HEALTHCARE TO GO PUBLIC?

The key difference between supporters and opponents of a universal healthcare system is whether guaranteed equal access to medical, dental and mental health services is a right or personal responsibility. Frankly speaking, looking at the statistics that demonstrates how “responsible” many of us are with respect to consumer credit, I understand why medical bills bring tens of thousands of un- and under-insured, even by conservative estimates (http://papers.ssrn.com/sol3/papers.cfm?abstract_id=587901), to bankruptcy each year. But, unlike our spending and saving habits that only affect our financial health, missing out on necessary care can leave a person temporarily or permanently disabled, or even lead to death. There is an article (http://www.msnbc.msn.com/id/30628634) describing how people are forced to ignore medical advice and to forgo recommended treatment because they just do not have money to pay for it. Basically, this is about us, as a society, being ready to provide healthcare to every legal resident, regardless of his or her ability to pay, and to make contributions to the appropriate fund(s) mandatory, just like Social Security Tax.

The Wikipedia article “Health care reform in the United States” (http://en.wikipedia.org/wiki/Health_care_reform_in_the_United_States) cites a number of publications and contains lots of information on the subject. One of the findings is that there is absolutely no evidence that public healthcare in all other developed nations, in which everybody has equal access to services, is more expensive, creates more waste and has worse outcome statistics than the system we currently have. That does not mean that it is ideal. But it is definitely better if we are serious about not leaving millions of Americans out due to financial reasons or pre-existing conditions. Patients can be less concerned about their health records being available to all providers they get care from, since there will be no reason to hide anything there out of fear that their insurance premiums will go up. Free market is not always THE solution. Let us address the issues that we know exist in public healthcare, but not reject it because of them.

TAMING HEALTHCARE COSTS

Looking for information on the breakdown of healthcare costs in the U.S., I came across a recent publication by the McKinsey Global Institute (MGI), titled “Accounting for the cost of U.S. health care: A new look at why Americans spend more”. The report contains some statistics and predictions, based on the current trends, which I personally found very alarming. For example, healthcare costs grow at a faster rate than GDP. In 2006, they accounted for 16 percent of GDP, and, according to the Department of Health and Human Services, will post “annual average growth of 6.7 percent over the next decade”. The Congress Budget Office projects that the share of healthcare spending will increase to 25 percent of GDP by 2025.

MGI analyzed healthcare spending patterns in 13 OECD countries and came up with a measure they call “Estimated Spending According to Wealth” (ESAW), which reflects the fact that countries with higher GDP per capita tend to spend larger portion of their GDP on healthcare. But even adjusted for wealth, in 2006, our combined healthcare expenses were $2.1 trillion, or $643 billion above ESAW.

MGI did not find any proof that we get a better value for the extra money we spend. Among the reasons why the current system keeps driving healthcare costs up well above their fair share of GDP, they mention several economic factors, which I interpret as follows:
· Relatively low and flat out-of-pocket expenses for insured patients
· Large number of uninsured Americans (16%). I believe that creates an incentive for providers to pass on un-compensated costs to those, who pay, in the form of higher prices
· Diagnostic procedures and treatment strategy are often chosen on the basis of maximum profitability for the provider
· Lack of statistical data from healthcare institutions, in part, due to patient privacy protection, keeps payers in the dark as to available treatment options for different conditions. They basically pay the asking price, and pass on the buck to their customers, raising premiums later on

It comes at no surprise that ambulatory surgery (ASC) and diagnostic imaging centers (DIC) are two fastest growing areas of healthcare, being extremely profitable. Sometimes, providers may seem obsessed with MRI or CT scan for almost every single encounter, but it also has obvious economic grounds. One of the solutions we could consider is to adopt the law that would require healthcare providers to switch to a CCHIT certified electronic medical record (EMR) system within, say, 3 years. The government should provide grants to public and community clinics and hospitals, delivering care to Medicaid and Medicare recipients, as well as to uninsured or under-insured patients, to assist them with the implementation of such a system. The patient must have the right to get all his or her medical information, collected or created during the encounter, in the electronic form on portable media, free of charge. EMR systems should be able to display that information, regardless of which of them was its origin. Insurance companies, if we keep our multi-payer system intact, or a single payer, whoever it may be, should create incentives for patients to request and share their medical records, by giving discounts or credits/rebates, respectively. The technology to support this already exists in the form of interoperability standards. It just needs to be utilized to stop the medical inflation from getting out of control.