Are ONC’s Meaningful Use Requirements Workable?

Office of the National Coordinator (“ONC”) for Health Information Technology health IT policy committee voted on July 16, 2009 to accept its workgroup’s matrix of qualifications that will be used to define Meaningful Use.  Compliance with ONC’s definition of “meaningful use” is essential to reimbursement bonuses and avoiding penalties under the American Recovery and Reinvestment Act of 2009 (ARRA).  Bonuses will begin in 2011 (maximum bonus payments for the implementation of a qualified EHR can be collected where an EHR is implemented no later 2012) thereafter the amount of bonus payments will be reduced with each subsequent year.  Penalties will begin accruing 2017 for Medicare and Medicaid providers who have failed to implement a qualified EHR.  A qualified EHR under ARA is essentially an EHR that meets the Government’s tortured definition of meaningful useful.

One example from the “Meaningful Use Matrix” requires that a provider – “Ensure adequate privacy and security protections for personal health information.”  This requires compliance with HIPAA Privacy and Security Rules.  Unfortunately the HIPAA Privacy and Security Rules are currently in a state of flux.  Assuming regulations are promptly promulgated the best case scenario requires a massive implementation effort of an EHR solution in less than a year.  The meaningful use matrix specifically requires a “security risk assessment”.  An entity “under investigation” cannot receive stimulus payments until the issue is resolved.  Length of investigation could also potentially include a missed payment (even if found “not guilty”).  The intent of this requirement was to disallow participation in HIT incentives if confirmed HIPAA violation goes unresolved.  The revised wording recommends – “that CMS withhold meaningful use payment for any entity until any confirmed HIPAA privacy or security violation has resolved.”

Potential issues arising from the tortured definition of meaningful use include:

1. Whether a company complies with the meaningful use requirements for 2011 will the company have to comply with the meaningful use requirements for EHRs adopted in 2013;
2. Whether a “confirmed HIPAA violation” is limited to situations where HHS has determined that a covered entity is not compliant and the covered entity was notified of said infraction potentially including a corrective action plan, or will a complaint be sufficient to meet the definition of a confirmed HIPAA privacy and/or security violation;
3. Whether requirements for interoperability and use cases for the EHRs can be implemented quickly (if not otherwise available in the EHR system);
4. Whether there will be a substantive change to the US Healthcare system.  A radical change could alter the playing field; and
5. Whether there will be sufficient data to support computerized provider order entries tied to electronic medication administration records and targeted order sets for chronic diseases including smoking, diabetes and hypertensive patients by 2011.

The lack of certainty and the resources needed to meet the EHR system meaningful use requirements will likely discourage hospitals and other providers from risking limited resources on an early EHR solution.  Given the absence of specificity it would seem that some may conclude that a wait and see approach is the most reasonable strategy.  Here the program requirements have been designed by politicians opposed to software engineers – can we expect that a hospital with limited resources would risk the investment to implement a system that may not work and may not meet some yet to be published future requirements.  Can we expect that EHR vendors will invest the resources necessary to meet system requirements developed by politicians?  The failure to build meaningful use upon previous ground work is concerning.

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