The Centers for Medicare & Medicaid Services recently announced a revised timeline for the implementation of Stage 3 “meaningful use” measures for the Electronic Health Records Incentive Programs, but did not extend the timeline for Stage 2.  Eligible providers who do not meet “meaningful use” requirements will be penalized with reduced Medicare reimbursements starting on January 1, 2015.  Additionally, the Office of the National Coordinator for Health Information Technology proposed a new regulatory approach to certification that is intended to allow certification criteria for EHR technology to be updated more frequently.

On December 6, 2013, the Centers for Medicare & Medicaid Services (CMS) announced a revised timeline for the implementation of Stage 3 “meaningful use” measures for the Medicare and Medicaid Electronic Health Records (EHR) Incentive Programs. On the same date, the Office of the National Coordinator for Health Information Technology (ONC) proposed to update on a more frequent basis its certification criteria under which EHR technology is certified as supporting meaningful use.  The Medicare and Medicaid EHR Incentive Programs provide financial incentives to eligible providers by demonstrating “meaningful use” of certified EHR technology.  The EHR Incentive Programs are staged in three steps with increasing requirements for participation.  Eligible providers who do not meet “meaningful use” requirements will be penalized with reduced Medicare reimbursements starting on January 1, 2015.

Under the revised timeline, Stage 3 will begin in 2017 for those hospitals, physicians and other eligible providers that have completed at least two years of Stage 2 of meaningful use.  These changes affect two groups of eligible providers: providers who started Stage 1 in 2011 and who are currently scheduled to start Stage 3 in 2016, and those providers who started Stage 1 in 2012 and who are currently scheduled to start Stage 3 in 2016.  The CMS announcement does not change when providers must start Stage 2, nor does it affect the requirement for eligible hospitals and critical access hospitals to upgrade to EHR technology that has been certified under the 2014 Edition EHR Certification Criteria in fiscal year 2014 to receive incentive payments for meaningful use, and for eligible professionals to upgrade to such technology in calendar year 2014 to receive incentive payments.  The CMS announcement also does not affect the timing of the reduced Medicare reimbursement penalties.

CMS and ONC stated that they changed the timing for Stage 3 to (1) allow CMS and ONC to “focus efforts on the successful implementation of the enhanced patient engagement, interoperability and health information exchange requirements in Stage 2” and (2) to “utilize data from Stage 2 participation to inform policy decisions for Stage 3”.  The change tracks CMS’s previous one-year rollback of the start date of Stage 2 for early adopters of EHRs, which similarly extended the length of Stage 1 by one year.  CMS believes this phased approach to program participation helps providers “move from creating information in Stage 1, to exchanging health information in Stage 2, to focusing on improved outcomes in Stage 3” and allows CMS to “support an aggressive yet smart transition for providers”.

According to a blog post by Robert Tagalicod, Director of CMS' Office of E-Health Standards and Services,  and Jacob Reider, ONC’s Acting National Coordinator for Health Information Technology, the revised timeline would offer several benefits, such as:

• More analysis of feedback from stakeholders on Stage 2 progress and outcomes

• More available data on Stage 2 adoption and measure calculations—especially on new patient engagement measures and health information exchange objectives

• More consideration of potential Stage 3 requirements

• Additional time for preparation for enhanced Stage 3 requirements

• Ample time for EHR software developers to create and distribute certified EHR technology before Stage 3 begins, and incorporate lessons learned about usability and customization

What the New Stage 3 Timeline Would Mean for Eligible Providers

Eligible providers who have completed at least two years of Stage 2 would begin Stage 3 in 2017.  It is anticipated that eligible professionals would begin in January 2017, at the start of the calendar year, and eligible hospitals and critical access hospitals would begin in October 2016, at the start of the federal fiscal year.

However, CMS did not delay the deadline for starting Stage 2 (which still begins in fiscal year 2014 for hospitals and calendar year 2014 for physicians).  Thus, for those providers who require more time to implement and test EHRs under Stage 1 criteria and are not ready to transition to Stage 2, the announcement did not provide any additional time.  Providers and vendors have raised concerns about the readiness of vendors to deliver EHR technology certified under the 2014 EHR Certification Criteria and about the ability of eligible providers to effectively transition to, implement and adequately test such Stage 2 technology within the compressed timeframe, without affecting patient safety, especially in the face of other information technology challenges facing the industry (e.g., transition to ICD-10, complying with the new HIPAA Rules, addressing health insurance and reimbursement changes under the Affordable Care Act, etc.).  The current Stage 2 implementation timeline may not provide adequate time for vendors to develop EHR technology that meets the 2014 EHR Certification Criteria, and for eligible providers to adequately test the functionality and interoperability of such complex mission-critical technology (within their unique environments), adjust workflows and train users.  The current Stage 2 timeline is also challenging for eligible providers still in the process of implementing EHR technology certified under the 2011 Edition EHR Certification Criteria under Stage 1 because they must upgrade to the 2014 Edition Certified EHR technology in 2014 even if they are still at Stage 1.   

Expected Timing for Rulemaking

CMS expects to release proposed rulemaking (NPRM) for Stage 3 in the fall of 2014.  Corresponding ONC NPRM for the 2017 Edition of the ONC Standards and Certification Criteria will be released in the fall of 2014, which will outline further details for this proposed new timeline.  The final rule with all requirements for Stage 3 would follow in the first half of 2015.

Changes to Certification Process

ONC proposed a new regulatory approach to certification that is intended to allow certification criteria for EHR technology to be updated more frequently.  This approach is ostensibly designed to:

• Provide public input on policy proposals

• Enable ONC’s certification processes to more quickly adapt to include newer industry standards that can lead to greater interoperability

• Add more predictability for EHR technology developers

It is anticipated that this new approach would spread out over a longer time period the certification requirements to which EHR technology developers have previously had to react.

ONC’s first step under this new approach would be to publish a proposed rule for a 2015 Edition EHR Certification Criteria that would be intended to improve on the 2014 Edition EHR Certification Criteria in several ways: the 2015 Edition would be responsive to stakeholder feedback, address problems found in the 2014 Edition, and reference updated standards and implementation guides that are expected to continue momentum toward greater interoperability.  ONC expects to propose that the 2015 Edition EHR Certification Criteria would be “voluntary” in that providers participating in the EHR Incentive Programs would not have to upgrade to 2015 Edition EHR technology and no EHR technology developer who has certified its EHR technology to the 2014 Edition would need to recertify its products.  ONC’s intention would be for the 2014 Edition to remain the baseline certification criteria edition for meeting the Certified EHR Technology definition.

The author would like to thank McDermott partner Daniel F. Gottlieb for his valuable contribution to this article.