EMR Certification: Government Warns “No Guarantee of Incentives”

ONC requires EMR vendors to “conspicuously” post the following disclaimer on all marketing material related to the certification status of their EMRs:

This [Complete EHR or EHR Module] is 201[X]/201[X] compliant and has been certified by an ONC-ATCB in accordance with the applicable certification criteria adopted by the Secretary of Health and Human Services. This certification does not represent an endorsement by the U.S. Department of Health and Human Services or guarantee the receipt of incentive payments. [emphasis mine.]

How ironic is that? Why is the government unwilling to make guarantees for a program that is government defined, government funded, and based on testing and certification conducted according to government specifications?

Could it be that ONC knows how difficult it will be for providers to actually achieve meaningful use and expects that many will fail? At its February 24, 2010, meeting—in the midst of the certification rule-writing process—the HIT Standards Committee went to great lengths to point out that certification only provides assurance that the capability for meaningful use exists, further clarifying as follows: “It will be up to the physicians to struggle to use the EMR to demonstrate meaningful use.” The government is abdicating its responsibility for having created an extremely burdensome and onerous program, and is attempting to shift responsibility for failure over to the physicians themselves.

The only people claiming to offer guarantees are the EMR vendors, and the required warning shows that ONC is concerned about their incessant marketing of deceptive promises. The following is just one example of the meaningful use “guarantees” that vendors have been promoting on their websites and in the proliferation of ads and webinars:

Federal Stimulus Bonus Payment Guarantee Program: This program guarantees that eligible physicians using our EHR, [product name], will receive their HITECH Act incentive payments for meaningful use.

Fine print buried on the website:

The Guarantee does not apply to any physician who fails to meet either of the following: (1) The standards under applicable privacy and security rules, and (2) specific required quality or administrative outcomes with specific performance goals. Both of these are outside of [vendor]’s control and can only be met by the individual physician. . . . Of course, in order to remain eligible for the Guarantee, each physician must actively use our solution to meet “meaningful use” criteria.

So why does ONC deny that certification is an endorsement by HHS? Tying $36 billion of government money to the use of particular products is about as significant an endorsement as there could be! The only explanation I can come up with is that ONC does not want to be responsible when many physicians—particularly the high-performance specialists—find, as they consistently have in the past, that these systems do not work in their practices.

As I have said in prior posts, “buyer beware!”

8 Responses to “EMR Certification: Government Warns “No Guarantee of Incentives””

  1. I believe that this is most unfortunate. I know that some physicians have changed to EMRs to be compliant. I know that there are still many “glitches” with EMRs and that many liability issues have risen because of improper use of EMRs. Doctors are faced with serious issues in an office setting. Costs are up, regulations have multiplied, there are no news of decrease in the cost of liability insurance. Tailing out can be quite expensive for physicians leaving practices in many urban areas. The equation is unbalanced.

    Thank you.

  2. That seems typical of the Federal Government and I strongly disagree that the physician must meet meaningful use… by his- or herself. The onus for meeting meaningful use falls with the EHR vendors NOT the physicians. That’s why there is a new certification process. A physician is engaged in the practice of medicine not as a programmer of informatics or analytics. They need to use an EHR as a tool just as they use a stethoscope or EKG machine. Remember patient safety, reduce costs, sharing patient information? How fast they forget. We have a list of preffered vendors that we recommend to our physician members but we have inserted a contract clause that the vendor must repay the physician if the product fails to meet meaningful use requirements and prevent the physician from receiving the incentive amount in any or all payment years. The vendor must agree to pay the incentive amount or provide another means of reparation. If the vendors want to stay in business, they better step up to the plate real soon.

  3. Evan, excellent article! I would never have picked that up. What we need is a lawyer to sue the HHS to make them choose either to endorse, or back off and pull the HITECH money once an for all.

  4. tony locastro September 30, 2010

    Very interesting reading. Not surprising

  5. Greg Buis September 30, 2010

    Nice article pointing out an unfortunate practice of government mandated regulations, standards, and certifications. It’s been the case with medical devices and FDA and aircraft and the FAA to name a few. Only the government has the option to excuse itself from the consequences of its actions. For all others, its “proceed at your own risk” and keep your lawyer at hand.

  6. Anil Kapoor September 30, 2010

    Certification is garbage. Let the doctor decide what is right for him/her. To begin with, the incentives are not all that. Second, the penalties are not going to force doctors, many doctors are not afraid of cutbacks. Good thing Evan brought this up.

  7. Agree it is garbage. All it is being accomplished is a consolidation across vendors to the point where the cost of software will skyrocket and the level of service will plummet. Forget about innovative solutions – what you will offered going forward is ‘state-of-the-art’ 1960ish ‘solutions’.

  8. James Meyers, MD, BSEE October 6, 2010

    I don’t find this critique to be thoughtful or informed. Meaningful use criteria include a number of things than can’t be guaranteed to work out of the box. For instance, “Incorporate clinical lab-test results into EHRs as structured data”. EMRs do this, they come with lab interfaces. Making it work in practice depends on a cooperative integration effort with the primary labs that service the practice. If a physician practice doesn’t make that effort, or won’t pay for that integration, it is not the fault of the vendor or the regulating agency.

    How about “Implement five clinical decision support rules, including diagnostic test ordering, along with the ability to track compliance with those rules.” The type of rules will depend on the practice type, obviously. My clinic might implement automatic reminders to order HgbA1C. An ophthalmology practice would choose differently.

    The EMR vendors should help to integrate and get these capabilities up to speed. Some will do this better than others. But if a physician practice doesn’t do their part, the vendor and the regulating agency can’t be held responsible, and shouldn’t be.

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