Sunday, August 29, 2010

Medicaid EHR Incentives – A Learning Experience

By now almost everybody that has any remote interest in Health Care is aware of the much publicized incentives made available to health care providers for the adoption and meaningful use of certified EHR technology. The most quoted number is $44,000 to be paid by CMS to Medicare physicians. Practically every EHR vendor website is adorned with a Flash banner “educating” doctors on this cash windfall, and practically every HIT detractor is warning that the incentives are just a pittance compared to the real costs of ownership of a certified EHR. Very rarely does anybody go into the intricacies of the available incentives for Medicaid providers, which are almost 50% higher than Medicare and involve clinicians providing care to our most vulnerable citizens. However, there is much to learn from the structure of the Medicaid incentives program.

The HITECH statute sets forth a “net” average allowable cost for purchasing and implementing an EHR at $25,000 for the first year and $10,000 for subsequent years. Of this “net” allowable cost, the Secretary of HHS is authorized to pay Medicaid Eligible Providers up to 85% in stimulus incentives for a total of 6 years. It appears that the Government is about to pay you 85% of your EHR costs for the next 6 years, which is a pretty good deal. Looks, however, can be deceiving. As any early adopter of EHR knows, the total cost of ownership for an EHR over 6 years is well over the “net” allowable of $75,000 set forth in the HITECH Act, and Congress knew that too. This is why the statute instructs the Secretary of HHS to determine the actual average allowable costs of EHR:

“(C) For the purposes of determining average allowable costs under this subsection, the Secretary shall study the average costs to Medicaid providers described in paragraph (2)(A) of purchase and initial implementation and upgrade of certified EHR technology described in paragraph (3)(C)(i) and the average costs to such providers of operations, maintenance, and use of such technology described in paragraph (3)(C)(ii). In determining such costs for such providers, the Secretary may utilize studies of such amounts submitted by States.”

The Secretary indeed researched and studied the actual costs of EHR adoption and, in the CMS final rule, came up with an average allowable cost for purchasing and implementing an EHR of $54,000 for the first year and $20,610 for subsequent years, putting the average cost of ownership for 6 years at $136,440 per Eligible Provider. This is closer to reality, although some would question if the Secretary brought into account loss of productivity while calculating these numbers. At this point, confusion sets in for most folks. If Congress already decided that they would pay no more than 85% of $75,000, why is the Secretary calculating the actual costs and showing us how inadequate the incentive payments really are? The answer lies in the little word “net”.

In the unlikely event that somebody, presumably the tooth fairy, gives you some money to buy an EHR, that amount of money must be deducted from the $54,000 for the first year, and your incentive amount is calculated as 85% of the remainder: First year incentive = ($54,000 – Cash gift for EHR)*85% -or- First year incentive = $25,000*85%, whichever one is smaller. The same logic applies to subsequent years. The only question now is what constitutes a cash gift for EHR technology. Well, the CMS final rule is pretty clear on that. First, State and local government contributions do not count. General grants for improvements do not count either. If you are employed by a Federally Qualified Health Center (FQHC) or Rural Health Clinic (RHC) or anybody else, and your employer purchases an EHR for you, that doesn’t count as a cash gift for EHR, and neither do any in-kind donations from vendors or other entities. Basically, unless someone not mentioned above hands you a wad of dollar bills wrapped in a note stating “This cash is exclusively for your EHR, doctor”, and that wad of dollar bills is greater than $29,000, your stimulus incentive will not be reduced.

You do have to show CMS that you paid for at least 15% of the "net" allowable EHR cost with your own money ($3,750 in the first year and $1,500 in subsequent years), but here is the beauty of the final rule: all those contributions from State, local governments, employers and in-kind donors, which did not count for calculating your “net” allowable cost, can be used to augment, and entirely substitute for, your out of pocket 15%. This is one of the most magnificent examples of bureaucracy at its very best, since when all rules and exclusions are counted, it seems that practically everybody will be eligible for the maximum incentive of $21,250 in the first year and $8,500 in subsequent years. It is worth noting that these amounts don’t cover even half of the Secretary’s estimated average EHR adoption costs.

How about Eligible Providers who are salaried employees, either in a cost-based FQHC or RHC, or any other fee-for-service entity? Most of these doctors assume that they have to assign their incentive payments to their employer, who provided them with the EHR. The CMS final rule clarifies that you can voluntarily assign your incentives to your employer, but you most certainly do not have to do so.

“We believe that, in accordance with 1903(t)(6)(A) of the Act, an EP could reassign payment to a TIN associated with his or her employer or the facility in which she or he works. …  Any reassignment of payment must be voluntary and we believe the decision as to whether an EP does reassign incentive payments to a specific TIN is an issue which EPs and these other parties should resolve.”

Reassignment of incentives to an employer, or any other entity promoting EHR technologies, is left to the physician and his/her employer. There are multiple strong warnings throughout the CMS final rule that such reassignment must be voluntary and the “States must guarantee that the assignment is voluntary”. For anybody contemplating creative arrangements that will reduce payments to employed physicians, in an FQHC for example, to compensate for EHR expenditures, CMS clarifies that “Incentive payments are payments designed to promote the adoption and meaningful use of certified EHR technology and are not payments for medical assistance provided in the FQHC. We do not have the authority under this program to provide that these funds be the basis for the State to reduce its per visit payment to the FQHC.”

In summary, if you are a Medicaid Eligible Provider in private practice, you can expect $63,750 from Medicaid over the next 6 years. If you are an employed Medicaid Eligible Provider, you should clarify with your employer what the expectations are. There is probably nothing regarding incentives in your contract, and while you could allow your employer to collect your incentives, nothing in the CMS final rule mandates that you do so, and quite the opposite is true. You may want to consider that an EHR will most likely reduce your productivity initially, and perhaps for longer than you expect. If you are practicing within a cost-based facility, your income will be adversely affected by the EHR adoption process, and it may make perfect sense to retain your incentive payments as partial compensation for loss of income, even if your employer paid for your EHR.

Sunday, August 22, 2010

The Government EHR

No, you didn’t miss anything, there is no Government EHR. But should there be one? And if so, what should it look like?

The argument in favor of a Government EHR goes something like this: If we have 19 Billion dollars to spend on EHR adoption, why not spend a small fraction of that money and buy or build an EHR and make it freely available to all physicians and hospitals? Not a bad idea. I would add that, if we must, we could spend the rest of those billions on training and supporting physicians in their efforts to computerize their records. So how would a Government go about accomplishing such monumental task?

The first option would be a “fixer upper”. Buy something like Epic, which has both an inpatient and an outpatient EHR, hire a team of software developers and hordes of usability and medical informatics experts and set them down to work on the existing product. A slightly less expensive option, which is frequently mentioned, is to use VistA instead of Epic. After all the Government already spent boatloads of money on VistA and many of its users seem satisfied with the product even in its current state. Epic has many satisfied customers as well. Either way, it shouldn’t take more than a couple of years to have a fairly usable product, migrated to new technologies, scaled down for small hospitals and practices and scaled down even more for patients.

The second option is similar to the process by which the Pentagon acquires new fighter jets. HHS would publish a set of requirements and various vendors would create a prototype and bid for the contract. For an EHR, one would expect the likes of Microsoft, IBM, Apple or Google to lead the pack. For this scenario the Government would be free to specify requirements to facilitate all the data collection the Government may need, and probably base the entire project on a Federal Cloud with Internet access either through a downloadable smart client (e.g. TweetDeck) or plain browser (e.g. twitter.com), or both, as circumstances dictate. We should have something to look at in three years or so and could begin rolling it out in earnest in four.

Either option will overcome most impediments to achieving an EHR for every American. A Federal Cloud containing all medical records will obviate the need of reporting to CMS or any other government agency. A true multi-tenant Federal Cloud will be able to uniquely identify each patient, with a very high level of confidence, and automatically create a National Patient Identifier without all the legislative and bureaucratic hassle. Since all data is managed by one entity, assembling a longitudinal, complete record for each one of us, either persistent or on-demand, will become almost trivial. One database schema, one terminology and a unified user interface would practically guarantee abundant and high quality data points for clinical research. Privacy and security policies, all residing in one place, could be driven by the patient, or consumer, through their own longitudinal, comprehensive view of the medical record. There will be no need for intermediaries and push/pull addressing systems with all the associated complexity. Every doctor, clinician, hospital, insurer, researcher and consumer will be accessing the same data, through the same software, within the scope of various privacy & security policies. And it will all be free.

For all those pulling “1984” out and looking to see if medical records are mentioned there, relax, this utopian EHR is not on the Government agenda at this time. There are as many obstacles to building the Federal Cloud EHR as there are to providing a “Public Option” for health insurance and neither one is politically feasible at this time. There is a large and rather influential Health Information Technology industry which will be summarily killed off by a Government EHR initiative. The need for instant gratification and the greater need for political campaigning material preclude anything with a longer than four years time horizon. Americans have a historical aversion to centralized control and would much rather have multiple smaller corporations control smaller chunks of activities and information, regardless of the administrative costs and pitfalls of such approach.

And then, of course, there is the freedom of choice issue. What if I don’t like the Government EHR? What if I want to build my own, or buy one that suits me better? And what comes next, a Government Automobile? And the right to privacy of both consumers and providers is not far behind. Why should the Government have access to every minute detail of my business? What would lawyers do if the Government would require that all their dossiers be uploaded to a Federal Cloud? What do the Constitution and Bill of Rights have to say about such practice? Certainly this is not what our founding fathers had in mind.

Of all the billions of dollars available for EHR adoption, the Government is timidly allocating $60 million to EHR research activities in areas such as security, usability, clinical terminology and some peculiar concept of making EHRs more like iPhones. I have very little hope of anything tangible materializing from any of these research programs anytime soon. In the meantime, tax payers, physicians and various providers of health care services, are spending billions of dollars on “fixing”, deploying and interconnecting fragmented software systems perfectly matching our equally fragmented insurance and health care delivery system. With enough duct tape, strings and wires, we should be able to pull something together.  We’ll fix the rest later….

Sunday, August 15, 2010

One Day in the Life of a Meaningful User

All the laws have been passed and all the final rulings have been published. In the spirit of the times, you went out and got yourself an EHR. You did your due diligence and sat through many hours of vendor demonstrations. In the end they all started to blend together, so you talked to friends and colleagues and accepted the Hospital’s offer to pay a big chunk of your EHR costs if you picked the one they wanted you to pick.
Your biller quit in disgust, but other than that the implementation was uneventful and the Hospital folks helped a lot. After several hiccups, your Medicare payments are coming in regularly now and your office is adjusting well to the new software. The documentation templates leave a lot to be desired, but you type well and when you find some free time you may take a stab at customizing them a bit. Here and there you run into bugs and a couple of times the EHR was unavailable for a good two to three hours. Not sure exactly why. Maybe it was the Internet that was unavailable.
Anyway, if all goes according to plan, you will be retiring in 10 years and your much younger partner will be bringing in someone who is probably in Medical School right now. Everything seems under control. But today is different...

Today is January 2nd, 2011 and you are driving to work. Today has to be meaningfully different and your first patient is waiting in Exam Room 1.

Mrs. Kline is a pleasant 68 year old woman, who has been seeing you for ten years or so, for her hypertension (which is well managed), hyperlipidemia and a touch of arthritis. You bring up her chart on your EHR and begin your meaningful use (§ 495.6(d)(7)(i) – Record Demographics - Check). There is a little red sign on the screen saying that Mrs. Kline is overdue for a routine mammogram (§ 495.6(d)(11)(i) – Clinical Decision Support - Check). She says that she got a little postcard from your office the other day (§ 495.6(e)(4)(i) – Patient Reminders - Check) and will be making an appointment soon. You look at the BP recorded by the nurse and also notice that Mrs. Kline gained some weight and her BMI is now well over 30 (§ 495.6(d)(8)(i) – Record Vitals and BMI - Check). You chuckle as you notice that the nurse duly noted that Mrs. Kline does not smoke (§ 495.6(d)(9)(i) – Record Smoking Status - Check). As you listen to Mrs. Kline’s account of her knees “acting up” again and how it is now painful to walk Fluffy in the morning, you glance at her problem list (§ 495.6(d)(3)(i) – Maintain Problem List - Check) and medications (§ 495.6(d)(5)(i) – Maintain Med List - Check). She also mentioned some shortness of breath when walking Fluffy and you proceed to do an examination.

As you look over Mrs. Kline’s slightly swollen knees and check her wrists and elbows too, she tells you about her daughter Ellie and how she is now a third year Dermatology resident. Mrs. Kline is hesitantly wondering if her daughter could peek at her medical records once in a while. Sounds reasonable and you tell her to ask Mary at the front desk to set her up with access to the portal (§ 495.6(d)(12)(i) – Electronic Copy of Medical Records - Check). You explain to her that all her records are on the computer now and even today’s visit summary will be there before she gets home (§ 495.6(d)(13)(i) – Provide Visit Summaries - Check) and (§ 495.6(e)(5)(i) – Timely Access to Medical Records - Check). Her daughter in faraway California should be well informed from now on.

The exam was non eventful and the Lipid panel Mrs. Kline had last week looks good (§ 495.6(e)(2)(i) – Incorporate Lab Results - Check). You proceed to write a new prescription for Celebrex (§ 495.6(d)(1)(i) – CPOE for Meds - Check) and note that she is not allergic to anything (§ 495.6(d)(6)(i) – Maintain Allergy List - Check). The obligatory DDI pops up and you dismiss it as duly noted (§ 495.6(d)(2)(i) – Drug-Drug Interaction - Check). You adjust the BP meds and note that everything is on formulary (§ 495.6(e)(1)(i) – Formulary Check - Check). You ask Mrs. Klein which pharmacy she is using and promptly send all her scripts there (§ 495.6(d)(4)(i) – Electronic Prescribing - Check).  On your way out you talk to Mrs. Kline about the need to monitor her blood pressure carefully now that she is on new meds and to call you if anything changes before her next appointment. You say good bye and good luck to her daughter. Mrs. Kline stops by the front desk and Mary sets her up with a portal account, makes an appointment for her and hands her the BP home monitoring education materials you ordered (§ 495.6(e)(6)(i) – Patient Education Materials - Check).  Your next patient is in Exam Room 2.

As you walk over to your office, Mary mentions that the IT guy will be coming in later today to fill out some security survey (§ 495.6(d)(15)(i) – Protect Electronic Health Records - Check) and test the export function one more time (§ 495.6(d)(14)(i) – Capability to Exchange Clinical Data - Check) and he is certain that it will work this time. There is a new patient in the freshly cleaned Exam Room 1.

It’s after five o’clock and light snow is falling outside. You saw 20 patients today; some with chronic conditions, some very ill (one had to be admitted) and others with incidental scrapes and viruses, but pretty healthy otherwise. There was nothing unusual about today. On your way home you briefly consider that at this rate you should have plenty of data to report to CMS in 3 months (§ 495.6(d)(10)(i) – Report Quality Measures to CMS - Check) and Mary with the IT guy should figure out the rest when the time comes. That Christmas bonus was well deserved.

This was just one of the 3,653 days until your retirement. The extra three are for leap years.
Congratulations, you are now a Meaningful User of EHR technology.

All quoted section numbers are from the CMS Fina Rule on Meaningful Use

Sunday, August 8, 2010

What’s in an EHR?

One of the most promising uses of Electronic Health Records (EHR) is Research. As EHRs become more and more widespread and the clinical data previously held in silos of paper charts becomes fluid, exchangeable and duly collected, large clinical repositories should emerge and be made available to those engaged in research, presumably medical research. The results of such research are expected to help us identify cost effective therapies, health care trends and a myriad other quality improving, cost reducing strategies. With such lofty goals in mind, it may be beneficial to look at the actual contents of an EHR as they are today and as they may be tomorrow.

The clinical data captured in many of today’s EHRs, and in all future EHRs, contains a very rich structured and codified data set.
  • Diagnoses complete with dates of onset and resolution (if any) and characteristics such as improving or worsening over time
  • Medications and Allergies, including all historical changes and adjustments
  • Procedures and Immunizations, including diagnostic procedures, surgeries and treatments, all with dates and some with outcomes
  • Hospitalizations, ED and Office Visit dates and durations
  • Diagnostic Tests and Screenings, including labs, radiology, cognitive screenings, genetic screenings, etc. all with results and dates of service.
  • Complete vitals over time, such as height, weight, blood pressure, etc.
  • Family Histories of disease and outcomes all the way to aunts, uncles, cousins, nephews and nieces
On top of the clinical data, EHRs also contain demographics and socio-economic data sets.
  • Names, addresses, emails, phone numbers for patients and sometimes family members if appropriate
  • History of insurance coverage over time with effective coverage dates
  • Pharmacies and testing facilities used in the past
  • Ethnicity, preferred language, level of education, occupation and employment history
  • Academic performance, preferred areas of study, schools and camps attended
  • Safety measures in the home (fire safety) and on the road (seatbelts, helmets)
  • Family circumstances, including number of children, miscarriages, sexual orientation, habits and abusive or predatory history
  • Travel, hobbies, diet, exercise, alcohol, coffee and tobacco consumption over time
  • Very limited financial information, such as credit card numbers, bill paying promptness and necessity of payment plans or discounts
By all accounts, this is an exceedingly rich data set and should facilitate almost any type of research one can dream of. We could examine the effects of various therapies on disease progression and estimate cost effectiveness and various correlations with socio-economic circumstance. We could study disparities. We could assess quality of outcomes, sliced and diced by region and institution type. The sky seems to be the limit, or is it?

As anyone engaged in research knows, data points are only one side of the story. Data quality is another. The most publicized assault on the contents stored in our EHRs came over a year ago from the, now very famous, e-patient Dave who attempted to download his medical records from a hospital into his Google Personal Health Record (PHR), only to discover that his EHR was laden with inaccuracies. There were diseases he never had, missing dates, missing meds and tests results, visits that never occurred and all that from one of the most advanced hospital EHR systems in existence. If you look at smaller hospitals and ambulatory practices, you will find that some medical records are electronic but some portions of care are still documented on paper. Patients sometimes ask their doctors to not document certain things and, given the option, some choose to “hide” sensitive information. Physicians sometimes dispense sample medications or call in a script and make only a cursory note in the EHR, or advice patients to see a specialist with no particular follow up documentation. Clerical errors are a given. The possibilities of incomplete, corrupt and misleading, data sets are endless. If that’s not enough, EHRs barely communicate with each other and creating an accurate picture of the continuum of care for any given patient shuttled from doctor(s) to hospital(s) to specialist(s) is nearly impossible.

One solution suggested by so called e-patients is the self-maintained PHR. Patients who want their “damn data” in a computable format seem to think that they could clean it up and make it usable for all sorts of innovative applications. The question here is of course whether the average patient has enough knowledge and enough information to correct the data set and accurately supplement it. For personal use, it is plausible to assume that some of us would be motivated enough and capable enough to create a decent longitudinal medical record in a PHR. For clinical research purposes, such PHR edited data sets would not pass muster any more than the deficient and erroneous original EHR data sets would.

The inescapable conclusion is that, currently, EHR data is ill suited to  the customary rigor of clinical research, and has very little to offer above and beyond claim data which is already in use for general studies on broad trends, such as the famed Dartmouth Atlas Medicare expenditures studies. Looking ahead, it is feasible to assume that data quality will be improving and as paper is phased out and EHRs become more robust, user friendly and widespread, and as privacy and security issues are resolved, we may indeed end up with the proverbial mountain of pure gold for equally pure clinical research.
With lots of patience, determination and proper stewardship, the long term societal rewards from Electronic Health Records are very clear. Right now, we just need to do the right thing and we all, physicians, patients, entrepreneurs, government regulators, know exactly what the right thing is.

Sunday, August 1, 2010

The EHR Circle of Trust

Every day millions of Americans and billions of people around the globe are routinely accepting colorful pieces of paper in return for their labor and placing those hard earned possessions in modern glass buildings whose owners they do not know. It took a few hundred years to change how business transactions are conducted, but today, there is very little apprehension about depositing one’s wealth in a bank. Public trust in both the government issued paper and the financial institution’s ability to safely store the increasingly virtual representation of buying power had to be painstakingly created and watchfully maintained.

When people, for one reason or another, lose trust in government paper or banks, the entire financial system fails miserably. Public trust is a prerequisite to any national monetary system and public trust is a very delicate thing. Nations create laws and regulations around financial institutions specifically aimed at building public trust. People have to trust that paper and its virtual counterpart can be exchanged for goods and they need to trust that banks, while safely storing their funds, will always make them available to their rightful owner on demand. Banks have a legal and fiduciary responsibility to take good care of your possessions, thus very few folks feel the need to store their family jewels in a strong box under their floor boards.

The fast approaching era of Health Information Technology (HIT) raises the same dilemma faced by our forefathers trying to decide if they should take their gold coins to the bank, or stuff them in a secret compartment of their jacket, or maybe bury them under the cowshed. We need to decide if we want to make our Electronic Health Record (EHR) part of a Health Information Exchange (HIE), or carry them with us on a USB stick, or just leave them locked up in our doctor’s office. There are obvious benefits and risks to each approach.

As long as banks were easily robbed on a daily basis, and as long as nobody guaranteed that your money was safe in a bank, and as long as you didn’t travel much, the cowshed was the best option. For the frequent traveler, the lovingly sown secret pocket was the optimal choice. When bank robberies disappeared from our daily experience and boats, railroads, automobiles and eventually airplanes transformed us all into a society of modern nomads, banks became the most practical choice, particularly since government insured our deposits were safe. Having a critical mass of citizens elect to store their wealth in banks allowed the economy to flourish. Millions of small personal fortunes aggregated together served as the engine by which banks fueled growth of businesses, which in turn created more and better paying jobs and ultimately added much value to those disparate small personal fortunes. Everybody benefited.

In 21st century America, most of us travel and change residence frequently. It would be nice to have our medical records be as portable as we are. Most of us use computers every day and couldn’t imagine life without the Internet. We also recognize the benefits of aggregating millions of data points to bring about more medical knowledge, better research and ultimately better health outcomes for everybody. So why is it that most people surveyed are as uncomfortable with EHR and HIE as Farmer John was with banks two hundred years ago?

In Health Care today we are at the “daily bank robbery” stage. It seems that every day another laptop loaded with clinical data is stolen, or a hospital computer system is breached. On top of that there is very little government assurance (HIPAA) that those holding our medical records should act responsibly and not use our personal records for “getting rich quickly” schemes while possibly inconveniencing, or even harming, us in the process. So before Farmer John can bring himself to deposit his medical records with an HIE, he needs evidence that not every fifteen year old with a gun (hacker) can easily avail himself of any records he chooses to have. Security of electronic medical information must be of Fort Knox quality. This is not currently the case when all sorts of unencrypted laptops and portable storage devices are floating around in employees’ cars and homes, and most hospitals and clinics have nothing in place even remotely resembling the security of financial systems.

When you deposit your valuables in a bank safety deposit box, banks are prohibited from peeking into your box, making lists of your possessions and sharing that information, unless required by law. When it comes to medical records, aggregators may hire a person familiar with statistics to attest that sufficient data elements were removed from personal records before a sale of information takes place, so only a “very small” risk of identifying the owner remains (HIPAA § 164.514), and there is no requirement for public disclosure of these shady transactions. EHR data sets are very rich with personal, not just medical, information and are worth many billions of dollars. Selling records to marketers, employers, “wellness companies”, insurers, pharmaceutical and device corporations should be explicitly prohibited by enforceable legislation. Aggregators of medical records should be allowed to modestly profit from supplying data to non-profit research institutions, and just like banks pay interest to those facilitating bank profits, medical records aggregators should share profits with Farmer John, either directly or by reimbursing providers for electronic data collection. And no, free software is not nearly enough compensation. Furthermore, any and all dealings and data exchanges should be fully transparent to the customer who chooses to deposit records with a particular aggregator. If Farmer John does not approve of an HIE’s policies and transactions, he should have the ability to take his medical records elsewhere. We need to know that our records are properly guarded and that we are the ultimate decision makers when it comes to their utilization. Public trust will follow.

Trust is not built in a day and trust is not created in complete darkness and trust will not come about without concrete evidence that trust is possible. Asking people to trust their life records to an unnamed chain of software vendors operating with no legally enforceable regulations, while the headline news are chockfull of medical records robbery announcements, is very similar to Jesse James requesting Farmer John to deposit his life savings at the rickety bank he is about to rob. Talk is cheap and Americans are smarter than that.  Like Jesse James, I am from Missouri, so “Show Me” trustworthy conduct and I will trust.

Sunday, July 25, 2010

Not So Meaningful EHR Certification

Can you buy an ONC Certified EHR, or EHR module, and discover to your chagrin that no matter how hard you try, Meaningful Use is not within reach?

While the spotlights were shining brightly on CMS and ONC as the final definitions of Meaningful Use (MU) and EHR certification criteria were being released, NIST quietly posted its (almost) final definition of EHR testing procedures for certification. The procedures still need ONC’s stamp of final approval, but it seems that this is just a formality. In the past I expressed misgivings regarding the “lightness” of the draft version of the NIST testing procedures, so naturally I was curious to see the final documents. Although some problematic procedures were simply removed from the final version, others still remain.

Thus the answer to the opening question above is a resounding Yes. In an attempt to part ways with the heavy handed CCHIT certification model, NIST adopted a simplistic, narrowly defined set of testing procedures. Vendors, particularly small ones who never underwent CCHIT certification, will likely be happy with the latitude afforded by NIST. However, the lack of specificity may very well place unsuspecting physician buyers in a bad situation, and here is how.
  • §170.302(h) - Incorporate laboratory test results: The final ONC certification rule does not require a particular standard to be used by the EHR for receiving structured lab results. All comments submitted to ONC requesting standard specification have been rejected in the interest of flexibility. Adhering to the ONC ruling, NIST allows the EHR vendor to select any format they desire for certification purposes. A comma or pipe delimited text file will do.

    National reference labs, like Quest and LabCorp, as well as smaller regional labs and hospital labs, are all standardized on some minor version of the HL7 2.X standard for transmission of lab results. An EHR, or EHR module, passing ONC certification with anything but the industry accepted HL7 standards will be unable to connect to any laboratories. The “older” EHRs, which have submitted to CCHIT certification in the past, all have working HL7 lab interfaces. The concern is with brand new products, certifying for the first time.

    Assuming the EHR, or EHR module, has HL7 capabilities for lab results, there is still a major hurdle to overcome. National reference labs have long implementation queues and stringent testing and certification processes of their own. It may take 6 months or so, for a new EHR vendor to establish the first live interface with a reference lab. Any subsequent interfaces must also undergo testing and could also take months to create, depending on both vendor and lab availability of resources.

    For a physician contemplating the purchase of a particular EHR this translates into a need to obtain documented proof from both the EHR vendor and the Lab(s) that operational interfaces exist for the Laboratories used by the practice. It also requires that you factor in the additional time it will take to create your particular interface(s).
  • §170.304(b) - Electronically exchange prescription information: NIST has decided that for certification purposes, only the ability to send out a new prescription will be tested. The entire test procedure consists of generating NEWRX messages according to the SCRIPT standard and sending them to a vendor identified external system. Successful testing is decided based on the correctness of the generated message. An EHR, or EHR module, conforming to this particular test is not guaranteed to be able to satisfy the MU criterion. Not by a long shot.

    EHRs need to connect to the Surescripts network in order to send prescriptions electronically to pharmacies. Surescripts requires the EHR vendor to go through an arduous testing process prior to being allowed to use the network. The ability to send out new scripts is only a small part of Surescripts testing. The vendor must have the ability to also receive error response messages from Surescripts and the pharmacy, receive and respond to refill requests from the pharmacy and send renewal messages to pharmacies. Surescripts must also be satisfied that the EHR’s user interface conforms to Surescripts standards. Surescripts certification is a lengthy process and it is not unusual for it to extend well beyond eight months.

    In a nutshell, a physician aiming to become a meaningful user and collect Government incentives must ensure that the ONC certified EHR about to be purchased is also Surescripts certified. ONC certification for this core MU requirement is meaningless.
  • §170.302(d) - Maintain active medication list: The minimalistic NIST test procedure for this criterion will not affect Meaningful Use or stimulus incentives. It may, however, adversely affect patient care. This test procedure actually presumes that each time a prescription is modified, such as changing dosage or frequency, any and all previous history of said prescription is erased. For example, if a few weeks ago you prescribed Celexa 20mg and today you and the patient decide to increase the dose to 40mg, the medical record will show that the patient was started on Celexa today, and the dose is 40mg. There will be no visible trace of the 20mg regimen in the EHR.

    Again, “older” EHRs, having gone through CCHIT certification at some point, will probably retain correct medication histories. New EHRs and EHR modules, written to the NIST testing specifications, may not. Unlike lab interfaces and electronic prescriptions, there is no obvious third party verification to look for when shopping for an EHR. This type of problem will not be discovered by a prospective buyer until the EHR has been purchased, installed and used for some time. At that point, with histories lost, the only recourse would be to request the vendor to provide an enhancement to certified functionality.
These are just the most obvious problems. Generally speaking, the test procedures are so narrowly defined that recording such things as who modifies allergies, vital signs, medications or problem lists, or when these were modified, or why, are not a requirement for passing the tests. Presumably, these are all recorded in the audit logs, but there is no specific inspection of the logs and anyway clinicians are not going to consult audit logs on a routine basis. Many other test procedures are of similarly superficial nature, suggesting that NIST is not attempting to certify a product as much as it is trying to certify a technology framework which could be ultimately used to build a meaningful product.

Bottom Line: Physicians need to understand, and ONC needs to clarify, that although required by CMS, ONC EHR certification does not guarantee availability of all EHR features and functionalities required to achieve Meaningful Use.

Sunday, July 18, 2010

Why EHR?

The regulators have completed their work. CMS has defined how you should use technology in your practice or hospital (Meaningful Use) and technical requirements for EHRs have been finalized. CMS and ONC have removed all ambiguity regarding Government financial assistance to those purchasing EHRs, and ONC certified EHRs will start appearing shortly. A national network of federally funded EHR adoption assistance centers for underserved Primary Care docs is slowly beginning to take shape. Everything you need to know to start your “EHR Journey” is in place. The only open questions left, for physicians with inquiring minds, are why should I buy an EHR, and why should I buy it now. Below, we will try to explore the answers provided by Government regulators, payers, patients and even early adopting physicians who completed the EHR journey or are in the last mile of the Meaningful Use race.

The Government

I cannot remember a similar situation in the past, where an entire election and much political capital has been invested in the software buying habits of a particular segment of the economy. Of course, the Federal government has been engaged in oversight and best practice dissemination in multiple cases, such as farming, public roads and education to name a few. However, you don’t see any Federal mandates for all schools, public and private, to adopt software, become paperless and collect and exchange terabytes of data. One could argue that such effort will bring enormous benefits to our, not so great, education system, probably as much if not more than to our health care system. Education, just like health care, suffers from lack of funds, poor quality and extreme disparities. The only difference between the two is the sheer amount of money involved.  This observation leads us to the inescapable conclusion that the national EHR effort is first and foremost about reducing, or containing, health care costs. In these turbulent economic times, the Federal government is betting the farm on the promise that computerizing medicine will put a significant dent in our runaway health care costs. Improving quality and reducing disparities, the other two stated objectives, are window dressing, or “nice to have”. To be fair, this is not a bad gamble. Computer technology has been shown over and over again to be capable of cutting costs in many other sectors, and the identified cost cutting targets in health care (duplication of tests, care coordination, administrative simplification, error reduction and standardization on Evidence Based Medicine) lend themselves very well to technological assistance.

Back to the physician contemplating an EHR purchase, the Government wants you to buy an EHR so you can provide care for your patients at a lower cost. As simple as that. The EHR must reduce your overhead, thus reducing cost per unit of service, and must reduce the direct treatment costs, presumably by helping you identify waste and less costly options for achieving the same results (or close enough). With these goals in mind, and ignoring the moral/philosophical arguments, EHR shopping just became significantly more challenging. To be sure, there are no EHRs on the market today, that can actually deliver on all these goals, but some may be able to provide a good start, and once interoperability is widely established, we should see more meaningful gains in cost containment.

Note: There have been more than a few grumblings out there on how a national network of EHRs is really aimed at obtaining patients and physician data to be eventually used for financially penalizing doctors. While I have no doubt that various quality and performance measures will eventually be used for payment purposes by both private and Government payers, I just don’t see this sinister, and very expensive, government plot to either spy on docs or nationalize health care unfolding in the midst of a recession, and with both the 2010 and 2012 elections very much on the line.

The Patient

Notwithstanding the vocal minority of e-patients and patients turned consumers, the vast majority of folks seeking medical care are interested in quality of care, convenient delivery and easy access. For the uninsured, the increasing numbers of underinsured and those with complex out of pocket arrangements (i.e. almost everybody but the exceedingly wealthy), costs of services are quickly becoming an important factor as well. Interestingly enough, this particular patient interest is very well aligned with the Government objective. The avant-garde of e-patients also wants access to their medical records and ability to participate in their own care. While not widespread just yet, it is conceivable that in the not too far future more patients will come to appreciate the convenience of communicating with health care providers over the Internet.

In a nutshell, your patients want to you to buy that EHR so you can reduce the price of care and save them time (and money) by allowing them to manage their medical care in a manner similar to how they now manage their finances. Your patients are a bit more selective than the Government though, and they are placing a more stringent constraint on maintaining and even improving quality of care while you cut costs and increase convenience. They are also planning on holding you to your sworn promises, and will expect that you protect their privacy while computerizing your records. Of course, the many underserved and really sick people in rural areas and inner cities couldn’t care less about your EHR. They will be grateful to just see a doctor outside the ED.

The “Industry”

Corporations on the periphery of actual care for patients, most notably payers, pharmaceutical and device companies and data mining companies, are really and truly only interested in your data. Private payers are also mildly interested in your ability to lower both your overhead (so they can cut your payments) and the total cost of care (so they can keep a larger percentage of the premiums). However, since the new regulations are forcing payers to spend a minimum percentage of their premiums on patient care, it is arguably better to have more expensive care and larger premiums. So for private payers this will be an intricate dance around the Medical Loss Ratio (MLR). As usual, private payers’ interests do not necessarily align with either patients or the Government. Payers also want you to computerize your records in order to reduce their own administrative costs (and again, keep a larger percentage of the premiums). There is little need to discuss EHR vendors here, since their motives are blatantly obvious and fairly legitimate in a capitalist economy.

All in all, the “Industry” wants you to buy an interoperable EHR, so they can collect, buy, sell and mine the vast array of personal and clinical information residing in your medical records, and worth many billions of dollars.

Note: Recently, the safety of EHRs, particularly hospital EHRs and their CPOE modules, has been the subject of various studies and much heated debate with no conclusive results. The possibility of FDA oversight has been suggested, and hopefully such oversight will be implemented sooner rather than later. However, here we are discussing private practice EHRs which are much simpler and restricted in scope.

The Early Adopters

These are your fellow docs who bought the EHR years ago and managed to make the endeavor successful. Their common denominator is mostly a personal willingness to invest time in molding the EHR to their needs, or the availability of an equally committed practice resource who was willing (or tasked) to do so. It is interesting to note that their EHRs come in a rainbow array of sizes and prices, ranging from $50 per month to tens of thousands of dollars in upfront investments. It’s not really about the product. There are perhaps three dozen credible EHR offerings out there (not the mythological several hundred), and as long as one is motivated and he/she plans early and plans well, there is a very good chance that the purchase of an EHR will add convenience for the physician and staff, quality and accessibility for patients, and if coupled with a decent billing system, even a bit of financial benefit.

Your early adopter colleagues are suggesting that you buy an EHR because theirs was a positive experience and they are now in a comfortable position to deal with the rapidly changing health care landscape. These doctors, unless working for a vendor, have no ulterior motives in their recommendations.

Note: As you are well aware, there are also physicians who failed in their EHR implementations and are bitterly warning against buying EHRs. I would venture to submit that it is not the idea of EHR that failed these folks, but the planning and implementation of it. Theirs is a very important learning experience on how not to buy an EHR and it needs to be listened to carefully.

Conclusion

The Government, the taxpayers (of which you are one) and your patients are all interested in reducing health care costs. At its core, EHR adoption is all about the economy, both on a national level and a household level, and with the approaching wave of value-based health care reorganization, it is on a medical practice level too. Since computer technology has been able to bring about cost reductions in many instances, it is reasonable to assume that it can do the same for health care, particularly once a critical mass of interconnected systems is reached. Your early adopter peers have shown that it is possible to introduce an EHR in one’s practice with some initial effort and inconvenience, but with no dire consequences and in some instances with marginal productivity gains. Since the overwhelming health care expenditures are accrued per “doctor’s orders” during millions of visits every day, and since an EHR need not be detrimental to your financial health, perhaps you should consider lending a hand to help rein in the Nation’s health care costs. Perhaps it is simply the patriotic thing to do.