Guest post by Amy Leopard, partner, and Kevin Alonso, associate, Bradley Arant Boult Cummings LLP.
On Sept. 4, 2014, the Centers for Medicare and Medicaid Services (“CMS”) published a final rule that, effective Oct. 1, 2014, implements changes to the Medicare and Medicaid Electronic Health Record Incentive Program in light of industry-wide difficulties in transitioning to EHR technology certified to the 2014 Edition EHR certification criteria (“2014 Edition CEHRT”) during calendar year 2014 for eligible professionals and fiscal year 2014 for eligible hospitals and critical access hospitals. CMS makes no changes to the existing 2014 reporting periods or the requirement in future reporting periods to report for a full year. This final rule also extends Stage 2 for an additional year for those providers first demonstrating meaningful use in 2011 or 2012. Instead of starting Stage 3 in 2016, those providers will now start Stage 3 in 2017. The timeframe for Stage 3 implementation by providers that first demonstrated meaningful use after 2012 is unchanged by this final rule.
Prior to these changes, providers were required to use 2014 Edition CEHRT to demonstrate either Stage 1 or Stage 2 meaningful use in 2014. The shortened 2014 attestation periods implemented in the 2012 final rule were aimed at helping providers make the transition from 2011 Edition CEHRT to 2014 Edition CEHRT, but delays affecting the availability of, and the ability of providers to implement, 2014 Edition CEHRT meant that many providers still might be unable to demonstrate meaningful use, despite their best efforts.
To provide some additional flexibility, CMS will now provide three alternatives routes to demonstrate meaningful use in 2014 for providers facing such difficulties: (1) using 2011 Edition CEHRT only, (2) using a combination of 2011 and 2014 Edition CEHRT, or (3) using 2014 Edition CEHRT for Stage 1 objectives and measures in 2014 for providers scheduled to begin Stage 2. These alternatives will also provide some flexibility in the objectives and measures that providers must meet to demonstrate meaningful use, as summarized in the chart below.
|State being demonstrated in||Attest using:|
|2014:||2011 Edition CEHRT||Combination of 2011 & 2014 Edition CEHRT||2014 Edition CEHRT|
|Stage 1:||2013 Stage 1 objectives and measures.†, ‡||2013 Stage 1 objectives and measures. †, ‡||2014 Stage 1 objectives and measures.**|
|2014 Stage 1 objectives and measures. †, *|
|Stage 2:||2013 Stage 1 objectives and measures. †, ‡||2013 Stage 1 objectives and measures. †, ‡||2014 Stage 1 objectives and measures. †, **|
|2014 Stage 1 objectives and measures. †, *||Stage 2 objectives and measures.**|
|Stage 2 objectives and measures. †|
|† Available to providers that could not fully implement 2014 Edition CEHRT in 2014 due to delays in 2014 Edition CEHRT availability.|
|‡ “2013 Stage 1 objectives and measures” are those Stage 1 objectives and measures under 42 CFR 495.6 applicable for 2013. If a provider elects this option, the provider must report clinical quality measures (“CQMs”) according to the Stage 1 final rule.|
|*“2014 Stage 1 objectives and measures” are those Stage 1 objectives and measures under 42 CFR 495.6 applicable for 2014. If a provider elects this option, or to use a combination of 2011 and 2014 Edition CEHRT for Stage 2 objectives and measures, the provider must report CQMs for 2014 according to the Stage 2 final rule and subsequent rulemakings.|
|** A provider using only 2014 Edition CEHRT must report CQMs for 2014 according to the Stage 2 final rule and subsequent rulemakings.|
This is not a free pass for providers to fall back on their existing EHR systems for the rest of the year. A provider may only use one of these alternative attestation methods if the provider can attest that they are unable to fully implement 2014 Edition CEHRT “because of issues related to 2014 Edition CEHRT availability delays.” Even if a provider that is slated to begin Stage 2 in 2014 attests using 2011 Edition CEHRT with 2013 Stage 1 objectives and measures, as detailed in the chart above, that provider still will be required to attest to a full year at Stage 2 using 2014 Edition CEHRT in 2015.
CMS makes clear that the delay in 2014 Edition CEHRT availability “must be attributable to the issues related to software development, certification, implementation, testing, or release of the product by the EHR vendor.” CMS does not provide an exhaustive list of circumstances that would make a provider “unable to fully implement 2014 Edition CEHRT,” but it does provide some instructive examples of what does not constitute an inability to fully implement 2014 Edition CEHRT, including financial issues of the provider, inability to meet the meaningful use objectives and measures despite the availability of 2014 Edition CEHRT (with limited exceptions), staff changes and turnover, and the provider’s own inaction or delay. In a nutshell, “[t]he basis for using one of the CEHRT options stems from a problem with first getting the software installed because of EHR vendor delays, and then fully implementing (including training, workflows, and related activities) 2014 Edition CEHRT in time for a full EHR reporting period in 2014.”
These changes will provide some welcome clarity and relief to providers who are struggling to implement 2014 Edition CEHRT because of vendor delays. The lack of a bright-line rule for when it is appropriate to demonstrate meaningful use in 2014 using one of these alternative methods will require providers to document their path toward implementation of 2014 Edition CEHRT meticulously, including dates when the EHR vendor provided 2014 Edition CEHRT and required software updates and timelines for system testing after installation, staff training, development of workflows, etc. Providers must not only be able to document a delay on the part of their EHR vendors, but they must also document how this delay has or will prevent their full implementation of 2014 Edition CEHRT to report for a full EHR reporting period. In the event of an audit, such documentation would be vital, as a failure to back up the attestation that the provider “is unable to fully implement 2014 Edition certified EHR technology for an EHR reporting period in 2014 due to delays in 2014 Edition certified EHR technology availability” could result in repayment of any incentive payments received for a 2014 attestation and the imposition of a payment reduction in 2016.
 Providers in their first year of meaningful use must use any continuous 90-day period. Providers who have attested previously under Medicare must otherwise use data from a calendar year quarter (in the case of eligible professionals) or a fiscal year quarter (in the case of eligible hospitals and CAHs). Under the Medicaid program, providers must attest using a continuous 90-day period (or 3 months at the option of the state).
 For providers attesting to meaningful use under Medicaid, note that CMS has revised the definition of “adopt, implement, or upgrade” for 2014 to apply only to 2014 Edition CEHRT, so as not to incentivize the purchase of a system that cannot be used to demonstrate meaningful use in subsequent years. 79 Fed. Reg. 52913.
 29 Fed. Reg. 52914.
 29 Fed. Reg. 52914.
 79 Fed. Reg. 52921.
 79 Fed. Reg. 52921-22.
 79 Fed. Reg. 52922.