Some thoughts on the IFR and NPRM published in January by ONC

Now that I have time to review the NPRM for Meaningful Use and the IFR for Standards and Certifications, I have developed several personal comments that are listed below.

1. One of the objectives of the ARRA sections on health care was to encourage clinician adoption of electronic medical records. Congress decided not to provide up-front funds to assist clinicians purchase and install systems. Rather, a method was developed to provide rewards for adoption and meaningful use of systems once they are being used. In my opinion, this was a flawed approach. The cost just to purchase an EMR is $40,000-$50,000 per clinician. The costs for annual maintenance and upgrades are not included. Most small practices are not staffed to handle maintenance of the software and infrastructure needed for the critical availability service needed in medical practice. The level of funding set aside for even the earliest adopters is not as large an incentive as it might seem at first glance.

2. The requirements for meaningful use are also problematic at multiple levels. My opinion is that those most likely to meet the demands of meaningful use are the clinicians and hospitals that have already adopted EMRs/EHRs rather than new adopters. The amount of time it takes to make a system selection, develop an implementation plan, change processes, perform the actual installation, and complete training aligns poorly for new adopters with the tight time schedules required by ARRA to realize the maximal incentives. Even those who are already using electronic records are going to be challenged to make the changes to their systems that will assure compliance with meaningful use requirements and achieve maximum incentive payment.

The certification program requirements have not even been released yet although some hospitals would need to start meaningful use of certified systems in the U.S. fiscal year starting in October 2010, only eight months from now. The infrastructure for the new requirements for certification of systems does not exist. This is extremely worrisome considering that the whole foundation of meaningful use is based on the use of certified systems. I do not think that it will be easy to develop criteria for certification of modules and self-developed systems used at many sites that represent some of the currently most advanced users.

Meaningful use reporting requirements are bloated measures, many of which do not have current electronic versions. I have great difficulty finding value to patients or the general public engendered in many of the types of reports required. I think administrators have gone way overboard in developing this area of meaningful use. As a clinician, I would be interested in utilizing measures that actually resulted in improved health care outcomes. Over emphasis on process measures just adds to the ever-increasing administrative overhead clinicians face. I must ask, why would a clinician spend the large amount of money need to install an EMR and then not use it? Failure to use an installed system would assume that clinicians were not convinced of the benefits of EMRs, especially increased patient safety and improved quality of care. Most current systems are hard pressed to provide the numerators and denominators required even for the stage 1 reporting requirements. The challenge is even larger for clinicians who practice in a number of facilities that may use different systems. Furthermore, the infrastructure needed for electronic reporting for the most part does not exist. Moreover, CMS is not prepared to receive electronically many of the measures now being proposed. I think there will have to be a whole new department at the federal level just devoted to collecting reports and making sure each system is meeting all the requirements to qualify for federal incentive payments.

The plan for the three phase implementation of meaningful use requirements is another major barrier to EMR adoption. This effectively guarantees at least every two year upgrades in software, needs for new training, and perhaps needs for new hardware that will not be welcomed by clinicians struggling falling revenues, increasing costs, and nearly impossible demands on time available in their daily lives.

3. There have been many industry-wide comments on the lack of specificity of published selected standards. One area of hot contention is the requirement to be able to process both CCD and CCR documents. Others have commented extensively on lack of clarity regarding the important information transmission standards. Finally, there have been many comments indicating that the selected privacy and security standards do not meet the needs of the health care industry.

Final Thoughts
I would have hoped for a plan that would have been more effective at encouraging new adoptions of EMRs. I would have wished for a concentration on standards that encourage true interoperability, especially of summary information, for a start. My final wish would have been for a very substantial commitment to development of the infrastructure for health information exchange. The state grants for health information exchange announced last week by ONC are barely a start for this important new resource.