Tuesday, August 23, 2011

CMS Owes an Apology to Meaningful Users

According to the July 2011 data from CMS there are over 75,000 clinicians currently registered for the various Medicare and Medicaid Meaningful Use incentive programs. A tiny fraction of these, 2246 to be exact, has successfully attested to meeting all Meaningful Use criteria (or claimed allowed exclusions), and about half have gotten the much coveted incentive checks. Considering that these figures include Nurse Practitioners, Dentists and Optometrists, it seems that the physicians that expressed interest in the incentives by registering with CMS are the same 6.9% that were identified by CDC in 2010 as using fully functional EHRs back in 2009. Even if we assume that the second half of 2011 will bring a surge in attestations to meaningful use of certified EHRs, it is still unlikely that a majority of those registered will go through attestation.

There are three broad reasons for these low numbers. First, there are those working their way through the 90 days attestation period as we speak, or are planning to start any day now. These folks have their ducks in a row and will attest in 2011. Second, there is a group that went ahead and registered with CMS “just in case”, but made no commitment to investing the energy and time needed to fulfill Meaningful Use requirements. These physicians are still debating whether they should upgrade their EHRs to a certified version, or if they already have a certified EHR, whether they are ready to begin documenting all the additional information in the specified formats as required for attestation. With less than 6 weeks left before the absolute last day for starting to measure, there is practically no chance that this group will be able to attest this year, and many registered with a clear intent to postpone Meaningful Use to 2012 anyway. Third, there is a significant number of doctors whose plans and efforts are being frustrated by shortcomings of EHRs and EHR vendors. This last group warrants a closer look.

Judging by press releases and earning reports from publicly traded EHR vendor companies, business is booming and EHRs are selling like hot cakes. The flip side, of course, is that waiting times for software installation are steadily increasing for both new purchases and upgrades. Since ONC certification bodies have no requirements stating that the certified software should be in actual use by customers, many vendors were able to certify EHR versions that were not ready for general deployment. Some vendors deemed it necessary to charge significant fees for functionality required for Meaningful Use in addition to the ongoing maintenance fees which should have entitled their existing customers to a free upgrade to the certified version. Adding it all up results in many unhappy customers having to wait in long lines for something that should have been forthcoming, and having to spend large sums of money on something that should have been free. And when they finally reach the front of the line and pony up the various extortion fees, they may still end up right back where they started.

Over a year ago, on this blog, I posed a very simple question: “Can you buy an ONC Certified EHR, or a package of EHR modules, and discover to your chagrin that no matter how hard you try, Meaningful Use is not within reach?” After a close look at the certification criteria for EHR software, my conclusion was that “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.” Of course physicians did not understand and ONC did not clarify and here we are today fully engaged in damage control. The problems range from rampant software defects to impossible workflows to plain missing functionality. How is that possible?

If you ever dabbled in software development, you should know that successfully testing a few predetermined isolated function points in a large software package is never an indication that the software works as designed. To use our beloved car analogy, starting the car once, turning the lights on once and activating the wipers once provides no solid indication that the car is not going to explode after two minutes on the highway, let alone that both wipers and lights will keep on working as you proceed out of the dealer parking lot. Now imagine that the car seller is allowed to performs all these tests while you are standing aside, observing the final result only. So a hotwire instead of an ignition key, a string attached to the wrist to pull the wipers back and forth, and a bunch of little flashlights instead of brake lights are all possible. That’s the essence of Meaningful Use EHR certification testing. Sometimes you get lucky and sometimes the thing you just bought smokes, and barely limps along sputtering motor oil and antifreeze.

But nothing is more misguided and inappropriately tested as the various requirements for interoperability. There are several Meaningful Use measures requiring that the EHR has the capability of exchanging information with other facilities, and that the user performs just one test of that capability to qualify for incentives, and the test does not even have to be successful. Sounds easy when you sit in a conference room overlooking blossoming cherry trees on the Potomac. Returning to cars, imagine that the requirement is that the vehicle is able to tow another car, or a U-Haul little trailer, or a boat. During certification, the vehicle presents with a lovely towing package installed; the tester attaches a cardboard car model to it and the entire assembly is shown to be able to advance one inch from where it was originally located. Hence, the vehicle is now certified for towing cars. The first thing you discover after you purchase the certified vehicle is that the various towing packages don’t come standard with the car. You will have to pay for each one and pay to have it installed. To add insult to injury, the towing packages have only been tested with cardboard models and there is much work to be done before they can be tested with real boats, cars and trailers. And there are several hundred customers in line ahead of you. Perhaps you should call again in a few months, or better yet don’t call us; we’ll call you.

To qualify for Meaningful Use incentives a physician must perform at least one test of submitting either public health data or immunizations data to a public agency. Exclusions apply to those who do not administer immunizations and to those who practice in a State where there is no public agency capable of accepting such data. There are less than a dozen agencies where one could submit public health data, but many more immunizations registries up and running. A typical very large EHR vendor will have operational interfaces to less than a handful of immunization registries that are readily available for purchase, usually in States where health information exchange is very advanced. Everywhere else money can’t buy you an immunization interface. It can buy you a place in line, if the vendor is working on an interface with your State registry. Otherwise a rain check is the most you should expect.

There is no way physicians could have anticipated this problem when they purchased a fully Certified EHR. There is nothing physicians can do now, or could have done earlier, to address this problem. And there is no way for EHR vendors to create over 50 working interfaces to State registries and deploy thousands of those interfaces to their customers before the clock runs out on 2011 reporting periods. By ignoring the reality on the ground, CMS erred in its requirement and ONC erred in its certification process. The only thing left to do now is for CMS to officially allow exclusion of public health measures across the board. An apology wouldn’t hurt either….

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