October 31, 2011
Farzad Mostashari, MD, ScM
Office of the National Coordinator for Health Information Technology
U.S. Department of Health and Human Services
200 Independence Avenue S.W. Suite 729-D
Washington, D.C. 20201
RE: Implementation of Meaningful Use 2 and re-implementation of Meaningful Use 3
Dear Dr. Mostashari,
The American Clinical Laboratory Association (ACLA) is an association representing clinical laboratories throughout the country, including local, regional, and national laboratories. Several members of our association are actively engaged in the Standards and Interoperability Framework Initiative (S&I Framework). ACLA agrees with the strategic direction of having a standardized HL7 results message to improve interoperability and selecting terminology to help drive structured data.
We want to bring to your attention our concern about the roll-out schedule for the S&I Framework that is staggered through Meaningful Use (MU) Stages beginning with Stage 2 (MU2) and continuing into the future. Laboratories have dedicated staff in place to handle normal business needs, but because the schedule for Eligible Professionals (BPs) to qualify for incentives is based on a calendar year, we anticipate a serious and on-going barrier to MU implementation, unless the Office of the National Coordinator considers changing the definition of “payment year” and / or the qualifying year/years for incentives.
In order for EPs to qualify for incentives, they must adopt and meaningfully use electronic health records (EHRs). The certification requirements for such EHR systems and for qualifying for incentives change with MU2 and can be expected to change for future stages. However, before an EP can meaningfully use an EHR that undergoes certification changes to accommodate MU2 and future stage requirements, the laboratory interface must be re-validated in accordance with the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
Validation of interfaces is a manual task that we anticipate will create a bottleneck of implementations with the adoption of MU2. That bottleneck will be exacerbated by the implementation of MU3, which will mean yet a third round of validation of laboratory interfaces. While EPs with certified EHRs will want to re-certify to qualify for CMS incentives, they cannot meaningfully use their EHRs without timely installation of the latest EHR versions, followed by validation that the EHR receives laboratory results for MU2 and laboratory orders for Meaningful Use Stage 3 (MU3).
Interfaces for EPs who already have certified EHRs must go through a validation process to ensure they meet relevant CLIAJCollege of American Pathologists (CAP) requirements. The validation process can take four to six weeks during periods of normal workload, even if the EP’s office is actively engaged in the process. With MU2, all existing interfaces would need to be re-validated before being placed into production. Re-validation of MU2 interfaces would be in addition to implementation requests received from normal business efforts. Thousands of EPs will be seeking to validate their systems at the same time for MU2 and later for MU3 so that they may qualify for the next payment year. Such peaks in demand can push waiting times to many months. Therefore, some otherwise-ready certified ERRs will not be re-validated in time for the EP to qualify for the next payment year — both for MU2 qualification and for MU3.
It is important to note that laboratories are not compensated for making changes to their systems to provide the data in the format needed by EPs to certify compliance with meaningfUl use criteria, nor are laboratories paid for validating or re-validating laboratory-ERR interfaces. Yet the complexity of the task and the number of re-validations required in a compressed time frame will require laboratories to prioritize implementations since they will not have additional funding to offset the additional expenses to comply with the changes required for ERRs.
We are writing to bring this impending problem to your attention. We believe that an appropriate solution would be for the “payment yea?’ to be based upon the date the interface has been validated / re-validated because of the likely bottleneck caused by thousands of interface revalidation requests. Taking this approach, EPs would certify to meaningful use for the year / subsequent years from the validation / re-validation of their interfaces, rather than on a calendar year basis. This would give laboratories time to re-validate interfaces without penalizing individual EPs who would otherwise be using their ERRs, but must wait fo the re-validation of the interfaces. Finally, another approach that would help address the problem would be to reimburse clinical laboratories for performing these validations or re-validations as part of MU. While this approach won’t completely resolve the issue, it would help address manpower needs.
Thank you for considering the issue outlined above and our specific proposals to alleviate the unintended consequences for clinical laboratories as a result of the implementation of MU.
Vice President, Government Affairs