Who Is A “Meaningful EHR User”

You may have heard that the government is giving money away to encourage doctors to start using electronic health records (EHR) in the U.S.  For “eligible providers,” that is true if the provider (a) uses a certified-EHR, (b) in a “meaningful” way, (c) by a certain date (approximately 2015), and (d) is eligible under the Medicare or Medicaid program based on makeup of the provider’s patient panel.  So, I guess that is sort-of giving away money.

The point of providing money to eligible providers is that EHR technology is expensive to acquire, implement, and maintain.  In fact, that is probably true of most computer technology (ever had to call a computer guy to remove a virus from your computer?  I think they are starting to charge as much per hour as lawyers!)  In addition, while eliminating paper systems undoubtedly saves some money to a practice in the longer term, but at least in the short term, these savings will not be seen in physician budgets.  So it helps if Uncle Sam pitches in some taxpayer dollars to get things started.  In this case, several billion over the next five or six years for the early adopters out there.

Certification

But, just spending some money on a computer system is not enough to qualify for these incentive payments.  A provider must use a “certified” EHR.  Only certain EHR’s are certified.  The list is available online here.  There are a number of organizations, like CCHIT, that act as certifiers of EHR systems.  These certifiers evaluate EHR software packages to determine if they have the minimum technology and functionality to be useful for practicing providers.  So, if you hire your IT-savvy son-in-law to write you a database to keep track of patient copays, you probably won’t be able to get those incentive payments!

“Eligible Provider”

Have a certified system?  Great.  But are you eligible under the program to receive the incentive payments?  That depends.  There are two basic tracks towards eligibility: Medicare and Medicaid.  You can obtain incentive payments under the Medicare program if you are a physician (including doctor of medicine, dental surgery, podiatric medicine, optometry, or a chiropractor) 45 CFR 495.100.  However, be careful.  If you are a physician, the amount that you can receive in incentive payments is a percentage of your total allowable Medicare charges, up to $15,000 for the first year, and less for the subsequent years.  So, if you have three Medicare patients that you see for $500 of allowable services a year, don’t expect a very large incentive check from the Medicare program.  See 45 CFR 495.102(a).

The other track is through the Medicaid program.  More providers are eligible under the Medicaid program, including physicians, dentists, certified midwives, nurse practitioners, and physician assistants (that lead a rural health center).  In order to receive incentive payments, the provider must have a patient panel where at least 30% of their patients are Medicaid recipients (20% for pediatricians), or the provider practices at a federally qualified health center and has a patient panel of at least 30% are “needy individuals” (which are both uninsured and Medicaid-eligible patients).  See 45 CFR 495.302.

Meaningful Use

You have a certified EHR system and you are the kind of provider that can participate under Medicaid or Medicare.  Great!  But are you a “meaningful user” as defined by the relevant regulations?  Well, that requires more effort on your part.  Namely, you need to meet the objectives that are described in more detail in 495.6.  For eligible providers, you have fifteen objectives listed in 495.6(d) that are “core” or required objectives to be met.  In addition, you must also meet five of the ten possible “menu” objectives that are listed in 495.6(e).  If that seems like a lot, well, you might be right.  And this list comprises the “stage 1” objectives.  Stage 2 and Stage 3 objectives are currently on the drawing board, and are anticipated to become the meaningful use objectives starting in 2013 and 2015, respectively.

Can it be done?  With some effort.

Note: there are different rules for hospitals as compared to providers that work in an outpatient setting.  You can read the complete regulations here (sans the comments and explanations): EHR Final Rule no comments.

Proposed Stage 2 Meaningful Use Guidelines

The Health Information Technology Policy Committee (HITPC) published for comment its recommendations for stage 2 and stage 3 meaningful use guidelines in order for health care providers that are using a certified electronic health record to continue to receive incentive payments throughout the full five/six years of the incentive program.  A copy of these recommendations are here: MU Stage 2-3.

The Stage 1 final regulations were published last year.  Depending on the track and facility type, (whether through Medicare or Medicaid, and whether you are an eligible provider or eligible hospital), there are a number of “core” and “menu” requirements that must be met for an organization or individual provider to receive incentive payments for the first 2-3 years of the incentive program.  HITPC’s proposal would define the additional requirements that must be achieved by providers/hospitals in order to receive the balance of the incentive payments that are available.

In some cases, stage 2 and 3 goals are for the same thing (such as electronic prescribing), but the target is higher to achieve the goal (for example, in stage 1, an eligible provider is supposed to send prescriptions electronically at least 40% of the time, while stage 2 and stage 3 proposed goals are 50% and 80% respectively).  In other cases, HITPC has suggested that a “menu” requirement transition to a mandatory or “core” requirement for stage 2.  An example is the patient reminder that is on the stage 1 menu list for eligible providers at § 495.6(e)(4).  If patient reminders become a “core” or required objective, providers today should probably plan to try to comply with this menu item now if feasible, particularly if this is easier to implement as part of the core EHR package.

There are also some proposed new objectives for stage 2 and 3, such as the goal that 30% of patients have at least one electronic note in the EHR (which, if the practice has implemented the system in 2011, by definition, all patients seen would have one or more electronic notes in the system).

A simple google search on these proposals will turn up many comments and criticisms of these proposed stage 2 and stage 3 objectives.  Importantly, for those practices that wait until 2013 or later to implement an EHR, these practices will have to comply with the then-current meaningful use stage immediately to be considered a “meaningful EHR user” under section 495.6.  See § 495.314.  Based on the present HITPC recommendation, waiting to implement an EHR will make it harder to be a “meaningful EHR user” as compared to those practices that have implemented this year and have had a chance to work out the bugs with the system and their workflows.

Disaster Recovery Planning

I had the pleasure recently to present to a group of IT and business leaders on the topic of disaster recovery.  Based on some of the questions and feedback from the group, I thought I would add some comments on this topic on the blog.

First, a fair number of attendees commented that they were having a hard time explaining the need for disaster recovery, or obtaining the necessary resources (either staff time, money, or both) to implement a solution.  Of the attendees, only a handful reported they had completed the implementation of a disaster recovery solution.  I think these are common problems for many organizations that are otherwise properly focused on meeting the computing needs of their user community.  Disasters generally happen infrequently enough that they do not remain a focus of senior management.  Instead, most businesses focus on servicing their customer base and generating revenue, and addressing the day to day issues that get in the way of these things.

Second, one of the attendees properly emphasized that IT staff are an important part of the planning equation.  Without qualified and available staff, a disaster recovery system will not produce the desired outcome – a timely and successful recovery, no matter how expensive the system itself costs.

Third, at least one attendee indicated that they had implemented a solution with a service provider, but the solution was incomplete for the organization’s recovery needs.  This is also a common problem for organizations that have significant changes in their systems over time, but disaster recovery is not included in the new system acquisition process.

Disaster recovery as a concept should not be introduced as an IT project, in spite of the fact that there are important IT components to any disaster recovery plan.  Instead, disaster recovery is a mindset.  It should appear on the checklist of items to consider for organizational decisions, along with other considerations like “how will this project generate revenue?” and “how will this project impact our commitment to protecting customer data?”

Disaster recovery solutions are more than just another virtual server or service.  Disaster recovery is another insurance policy against the uncertainty of life.  Organizations routinely purchase liability insurance, acts and omissions insurance, and other insurance policies on the basis that unanticipated negative events will inevitably occur.  System failures, computer viruses, and other environmental failures are inevitable, even if rare.  Disaster recovery solutions are a hedge against these unfortunate events.

Risk assessments for information systems help organizations to quantify their exposure to the unknown, and to estimate the potential impact to the organization if a threat is realized.  Risk assessments also provide an orderly way to prioritize system recoveries, so that a disaster recovery solution focuses on mitigating the largest risks to the most critical information systems.  As was pointed out at the presentation, payroll systems often seem the most critical systems, but the mitigations for the unexpected failure of a payroll system may not be a computer solution at all.  Instead, the organization may elect to simply pay employees cash based on their last pay check, and reconcile payments once the payroll system is available again.

Meaningful Use – Some Thoughts

HHS and CMS have released the regulations as promised to help define the phrase “meaningful use” that can be found within ARRA and will determine which health care professionals have been naughty and will receive no incentive payments from Uncle Sam, and those that have been nice and will.  The regulations themselves are long.  I can’t be critical on length alone; the regulations reflect the complexity of the area they intend to regulate.  To date, the regulators have drafted the Stage 1 measures for meaningful use.  These measures will determine whether the relatively early adopters of EHRs will receive incentive payments under Medicaid or Medicare (if the provider otherwise qualifies).

This post takes a closer look at the Stage 1 criteria.  There are a number of requirements that are basic to any self-respecting EHR, such as §§ 495.6(c)(1) drug interaction checking, (2) a problem list for each patient, (3) a medication list, (4) an allergy list, (5) basic patient demographics, (6) basic vital signs, and (7) the patient’s smoking status.  Most systems will store this kind of data in discrete data fields and can make this information available to be queried for reporting.  Section 495.6(c)(8) mandates that lab data reported back to the provider be stored in a structured format.  This is also a basic dimension of an EHR, though it takes more effort to get this to work efficiently (including someone with the job of maintaining the mappings that take reported lab results and place them in specific data elements in the database).

Section 495.6(c)(9) mandates that the provider be able to generate a list of patients by disease state.  Assuming that patient diagnoses are stored in a structured format, this also should not be too difficult to address with most systems.  The medical staff would need to provide some data definitions (for example, the diagnosis codes 042 and V08 both mean HIV; a series of diagnosis codes that start with 250 mean diabetes, and so on).

Section 495.6(c)(10) mandates that there be five decision support rules that can be built into the EHR and that are specialty or priority-specific.  For example, all HIV patients in care should have an HIV viral load test performed at least every 4-6 months.  Some systems may not support these kind of point-of-service reporting tools (so that the provider is reminded when in the exam room with the patient), but presumably a reporting tool that generated reminders to patients to receive a particular test or service might meet this requirement.

However, the regulations take a turn at (c)(11) when they mandate the use of electronic eligibility data and the submission of electronic claims data.  These are both not the typical province of an EHR, but of a practice management system.  And while there have been ANSI standards for electronic eligibility data published for years, there are still some insurers that cannot produce useable data for eligibility verification.

Section 495.6(c)(13) calls for a medication reconciliation at each office visit with the patient.  I presume the intent here is to have the provider ask the patient to verify that all these pills listed in the EHR are really what the patient is taking.  I’m not sure asking this question at every visit will be practical with every patient – particularly with the patients at the most risk for interactions – those on a large number of different drugs.  Health information exchanges may help to tame some of this by presenting to the physician listings of drugs associated with the patient from multiple sources, but truthfully, this may quickly become bewildering for both the patient and provider.

Section 495.6(c)(14) calls for a record summary to accompany each referral for specialty care.  With the paper referral system today, this will increase the amount of paper shared between practices.  I would hope this requirement would push more providers into participating in an HIE so that this kind of thing could be shared electronically.

Section 495.6(c)(15) and (16) are addressed to sharing data with certain governmental agencies for tracking patient immunizations and reportable diseases that are surveilled by local health departments.  Presumably both of these would be better addressed by having the government agency participate as a recipient of data from an HIE, rather than building an interface directly from a provider to the agency requesting the information.  The issue here, however, is that the items to be reported are probably not likely to be initially available from the HIE because these data elements may or may not be consistently stored across EHR systems (particularly immunizations; reportable conditions are often keyed to a particular diagnosis code, such as the codes for syphilis or HIV, and problem lists are more often consistently stored as structured data).

And, even though risk assessments have been mandated since 2003 within the HIPAA security regulations, CMS felt that this specific requirement needed to be reiterated within the meaningful use regulations.  My guess: most providers don’t regularly perform risk assessments because they are time-consuming, and information systems change to frequently for the risk assessment process to keep track.

Section 495.6(d) provides another 8 requirements for providers.  Notably, the regulations mandate direct patient access to their health record chart electronically, and the ability to feed data to patients on request (for example, for patients with a personal health record that want to get a live feed of lab results and medications from their doctor).

Overall, the regulations are substantial.  Some of the requirements in the regulations will cause some consternation for providers and will likely lengthen the time to implement EHRs for some organizations that were focused on the basics of just getting the visit documented in the system.

Meaningful Use Gets A Definition

The Centers for Medicare and Medicaid (CMS) and the Department of Health and Human Services have released for public comment proposed rules that help, among other things, to define “meaningful use” in the context of electronic health records systems.  As astute readers will note, the federal government intends to start making incentive payments to qualifying providers in 2011 who can demonstrate meaningful use of a certified health record system.  2009 was spent trying to figure out just what that phrase means, and the proposed rules (available here) provide the first formal attempt at definition by CMS.

There are three stages of meaningful use, which must be demonstrated at various points during the incentive payout schedule, depending on when the provider adopts an EHR.  If, for example, a provider adopted an EHR in 2011, the provider would be required to demonstrate Stage 1 compliance in 2011 and 2012, Stage 2 compliance in 2013 and 2014, and Stage 3 compliance in 2015 in order to receive the incentive payments from the Medicare program.  (There is a helpful chart on page 46 of the draft regulations).  If a provider were instead to adopt in 2015, they would have to demonstrate Stage 3 compliance.  For those of you thinking about waiting a few years before adopting an EHR (apparently we “adopt” rather than “birth” these systems, though from the squeals of some users, I would think the pangs of birthing are a more appropriate metaphor), be forewarned: late adoption means the expectations are higher with regards to demonstrating meaningful use if you want to get an incentive payment.

Stage 1 requirements are described in the proposed § 495.6(c), and include the following items:

(c)(1) drug interaction checking

(c)(2) problem list

(c)(3) active medication list

(c)(4) active allergy list

(c)(5) basic patient demographics

(c)(6) record basic height, weight, blood pressure, BMI, and peds growth charts

(c)(7) smoking status

(c)(8) store lab results in structured data format

(c)(9) be able to produce a list of patients by disease condition

(c)(10) implement 5 clinical decision support rules based on provider specialty or priority

(c)(11) use electronic insurance eligibility

(c)(12) submit claims electronically

(c)(13) perform a medication “reconciliation”

(c)(14) provide a summary of care record for each referral, or “transition of care”

(c)(15) capacity to submit data to immunization registries

(c)(16) capacity to submit electronic surveillance data to public health agencies

(c)(17) comply with HIPAA security regs via risk assessment and mitigations

And if that wasn’t enough, section (d) gives some more rules to comply with:

(d)(1) use “computerized provider order entry”

(d)(2) send prescriptions electronically

(d)(3) report ambulatory quality measures to CMS

(d)(4) send patient reminders for preventive care

(d)(5) provide patients with electronic health record data on request

(d)(6) provide patients with timely electronic access to their health data

(d)(7) provide each patient a clinical summary at each visit

(d)(8) exchange data with HIE’s

There is a helpful chart of these requirements that starts on page 103 of the proposed regulations, and points out where the criteria vary depending on whether a hospital or individual provider is attempting to demonstrate compliance.  The regulations also propose measures to demonstrate compliance with each requirement in Stage 1, which is included in the respective requirement’s section.

Now, you probably are wondering what the Stage 2 and Stage 3 criteria are.  From my reading of the regulations, these have not yet been promulgated.  CMS is, however, working on it.  They even give you a teaser on page 109 of some potential Stage 2 requirements.

Many of these requirements are hardly a shocker (recording a patient’s name and their height, weight, and what medications they are on, for example).  These core requirements are essential to any system purporting to manage health.  There are, however, a number of very interesting requirements which may be much harder for systems to obtain.  For example, requiring that 80% of patient insurance information be verified electronically may be quite a stretch (and in many cases, this is not handled by a health record system but instead by a practice management system).

Also, providing patients with electronic access to their health data within 96 hours of its receipt may also require a wave of web site, firewall, and secure socket layer certificate purchases by providers, many of whom do not support this kind of access today to their health record systems.  And while it would be wise to perform a medication “reconciliation” at each visit, it is not clear how this would be accomplished from the regulations as written.

Stay tuned for additional postings on this very important topic!  And be sure to send in comments to CMS on these rules based on your experiences with EHR technology in your practice.

From My Pen to Your e-Record

Vernon Huang, an anesthesiologist, and his company, Shareable Ink, have created a pen that both writes on paper, and transfers your writing to an electronic health record system through the use of a tiny camera in the pen that keeps track of what you are writing.  (see article here)  Given that a majority of health care providers still use paper records today as a way to document patient visits, a pen that allows for conversion to paper’s electronic cousin is a welcome improvement in the health records environment.

Dr. Huang also notes that the pen allows for the conversion of data into discrete data elements as part of the import process to the health record.  So, for example, a medical assistant documenting a patient’s heart rate and blood pressure on paper with the pen can have those discrete data elements entered into the patient’s chart as individual data elements for reporting and analysis.

This invention is an interesting twist on EHR adoption issues.  One of the main problems that users complain about is the loss of speed (or the sense of loss of speed) that results from having to use a keyboard and mouse to document patient care.  This is particularly acute in practices that rely on high daily patient volumes to keep the doors open, such as the private practice of your family doctor, pediatricians, and some specialists (my dermatologist was done with me in 8 minutes flat, and that included me getting undressed).

There are other security concerns with a pen that makes entries into a database system (like non-repudiation – that we know who purports to be using the pen is really the person they say they are), but this invention may go a long way to moving resistant practices to an EHR.  Remember – Medicare and Medicaid will pay between $50,000 and $60,000 per qualified health care provider in incentives for those that adopt an EHR and demonstrate “meaningful use.”  Stay tuned.

The Quest for Meaningful Use

Section 4101 of the American Recovery and Reinvestment Act creates an incentives program for Medicare providers (and a penalty program after 2015 with regards to reimbursement) for EHR adopters.  See this article from June 2009 on “meaningful use.”  See also an earlier blog post on ARRA incentives here.

One of the provisions for receiving incentive payments is that the provider can demonstrate “meaningful use” of the EHR system.  The section also requires that this meaningful use occur on a certified EHR system.  The term “meaningful use” is not defined by the statute, except as follows: “(i) Meaningful Use of Certified EHR technology – The eligible professional demonstrates to the satisfaction of the Secretary, in accordance with subparagraph (C)(i), that during such period the professional is using certified EHR technology in a meaningful manner, which shall include the use of electronic prescribing as determined to be appropriate by the Secretary.”

The phrase is not defined by the statute, but presumably will be defined by the promulgation of a regulation by the Secretary of Health and Human Services.  The thinking today is that meaningful use would be defined by the achievement of certain milestones over time by providers using EHRs.  Initially, the focus would be on actually putting data into the system.  With time, the definition would expand to being able to look at data trends over time and evaluate this data for trends.  And eventually, providers would be required to have an actual impact on patient health outcomes.  There is likely to be a similar movement within the private insurance world for providers, as in a “pay for improved outcomes” model, moving beyond just reducing the number of times someone comes to the doctor’s office (the old, HMO model of quality).

In more practical terms, a provider that wanted to demonstrate meaningful use would need to buy some software, take it out of the box, and actually use it to put some kind of data into it.  Most likely, a more sophisticated system purchaser would give some thought to how that data would be organized within the computer system, with the goal of being able to get it back out again on demand.  In the paper health record world, this is comparable to having a paper note to document the visit, and a separate flowsheet that is maintained to track certain kinds of lab results over time.  The flowsheet is the manually created output which ultimately can be used to evaluate patient outcomes to treatment.  For example, an HIV patient is routinely checked for his or her HIV viral load.  A lower number (or an undetectable viral load count) is better than a higher one.  HIV care providers also keep track of the number of CD4 cells in a given blood sample: a higher CD4 count is better than a lower one.  Over time, these two values are related to each other, and also predict if a patient is doing better or worse with the disease.

An observant provider would educate the patient about these lab results and their implications for health, and demonstrate how close adherence to the schedule for taking HIV medications helps improve the patient’s health over time.  An HIV provider would also be watching for unexpected changes in these values to determine if the patient should be evaluated for resistance of the disease to the current regimen.  HIV is an expensive and high risk disease to manage; but it only gets more expensive if the patient’s condition is not managed appropriately (with lengthy hospital stays, complications and other health issues).  In addition, a patient’s quality of life goes down the tubes with the progression of the illness; usually the side effects of the medications to treat the illness are the lesser evil.

An EHR can help to improve the efficiency of this quality and management process for providers.  A well-designed and implemented system will place relevant lab values onto an electronic flowsheet which can be charted and analyzed over time, avoiding the time spent updating the paper forms and reducing errors in data entry.  In addition, an EHR can present multiple views to the data depending on the patient’s health condition, and can help manage care to accepted standards by reminding providers of tests or actions that are due (such as annual pap smears, 10 year tetanus boosters, quarterly viral load testing, STD screenings, etc.)  EHR’s can also cut down on duplicate tests being ordered (at least within a practice that uses the system) if a patient is seen by more than one provider over time, as all have access to the same information in the same format.

While not yet fully defined, meaningful use will likely lead our nation to more defined care standards, with incentives (and potentially penalties) for better outcomes.  But a word of caution – patients ultimately have to make decisions about their own health.  Not everyone is convinced that having a BMI over 30 is bad enough to warrant exercising an hour every day and cutting calorie intake by 25-50%.  Or consider smoking, which leads to a fair amount of bad health outcomes over time, yet how many Americans still smoke?  Penalizing physicians for the stupid choices that patients make is not fair, even though the health outcomes for these patients will be worse than if the patient had listened to their physician.  Expect the definition for meaningful use to be published soon, but also expect changes over time, particularly on standards for health outcomes.