In 2014, ONC passed a rule that allowed providers to receive funding for EHR systems that did not meet the standards that were current at the time.
The funding program for Electronic Health Records (EHRs) in the United States is called the Meaningful Use program, because healthcare providers, mostly doctors and hospitals, are required to demonstrate that they have actually used EHR technology to benefit patients in a meaningful way.
There are three stages for funding in the EHR incentive program, and in 2014 many healthcare providers were supposed to upgrade from the first stage to the second stage of that funding program. Each stage requires hospitals and doctors to leverage more and more complex EHR software. EHR software that was certified to the 2011 standards was meant to be used by hospitals and providers to achieve Meaningful Use Stage 1, in 2011, 2012 and 2013. After that, doctors and hospitals were supposed to adopt EHR software that was certified to the standards released in 2014.
However, many hospitals and doctors protested that the EHR vendor community was not providing access to EHR software certified to the 2014 standards in a timely manner. This created a situation where providers “through no fault of their own” were unable to attest to Stage 2 of the Meaningful Use standards.
In order to ensure that healthcare providers were able to access Meaningful Use funds, ONC released a rule that allowed providers to receive Stage 2 Meaningful Use funds while using Stage 1 EHR software. However, Meaningful Use participants were only able to claim access to these grandfathered funds if they claimed that they had been able to fully adopt current certified EHR technology (or CEHRT) because some vendor did not offer, or improperly supported, the roll out the new 2014 certified EHR software. This grandfathering of funds is generally called the “flexibility rule” because it allows for hospitals and providers to have flexibility in which versions of CEHRT they attest under.
This was a very controversial policy decision at the time, and it is only with newly accessible data that we are now able to analyze the impacts of this policy on the EHR marketplace. We expect to be releasing more analysis on this issue, and before we do that, we thought it would helpful for us to release a short “required reading” list for those who are interested in this policy decision. This is in addition to our already released comparisons between the Meaningful Use overview for hospitals and Meaningful Use overview for providers.
Specifically we wanted to detail the rules for when this grandfathering was allowed, and when it was not. If you want to track the source policy documents for the flexibility rule you can find them here:
- Press release for the proposed flexibility rule
- The proposed flexibility rule
- Comments on the proposed flexibility rule
- Press release for the final flexibility rule
- The final flexibility rule
- This document details how you would use the attestation system to exercise the flexibility rule.
The final rule has specific responses to comments that clarify what counts as valid reasons for exercising the flexibility rule vs. those which do not.
The specific phrase that the final rule puts forward is:
Providers who choose this option must attest that they are unable to fully implement 2014 Edition CEHRT because of issues related to 2014 Edition CEHRT availability delays when they attest to the meaningful use objectives and measures.
and later emphasis
…we stress 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 which affected 2014 CEHRT availability, which then results in the inability for a provider to fully implement 2014 Edition CEHRT.
Specific reasons that are listed as acceptable under this criteria include:
- Waiting for the availability of certification of 2014 CEHRT.
- Waiting for installation of 2014 CEHRT.
- Waiting for updates or patches to 2014 CEHRT.
- Patient safety issues related to the adoption of flawed 2014 CEHRT.
- The attester has multiple software components, at potentially multiple sites, and some of them are incompatible with a 2014 edition CEHRT.
- A site was unable to reach the an interoperability goal because their referral partners did not have 2014 CEHRT.
The last one is especially interesting, because it allows a hospital or doctor to attest to use the flexibility rule because some other hospital or doctor was not using the right version of CEHRT.
The response to comments also lists specific reasons that would not qualify a hospital or a practice to use the flexibility rule:
- Financial problems (i.e. not paying for 2014 CEHRT or not paying to implement it).
- A provider waited too long to attest.
- Failing to meet a threshold for an 2014 attestation measure.
- Staff attrition.
As we perform our analysis on this data, it would be invaluable to know precisely why a specific provider or hospital represented that they were exercising the one of the options under the flexibility rule. It would be lovely if we knew, for instance, which sites A. had no CEHRT to install at all vs B. the CEHRT was available but it was flawed vs C. they were unable to exchange data because none of their peer sites were using CEHRT, etc. This information is apparently unavailable. During the attestation process, there was no requirement to categorize why the flexibility option was chosen, but only that it was due to “the unavailability of 2014 CEHRT”.
Providers are required to maintain documentation of their reasons for choosing the flexibility option, but this checkbox was all of the data that was gathered regarding the flexibility option. This documentation requirement was emphasized for the interoperability threshold issues:
However, the referring provider must retain documentation clearly demonstrating that they were unable to meet the 10 percent threshold for the measure to provide an electronic summary of care document for a transition or referral for the reasons previously stated.
Currently there are two different auditing programs that could theoretically check up on the reasons for choosing the flexibility option. The Office of the Inspector General audits the Meaningful Use program. Which is distinct from the Meaningful Use audit program by CMS itself, which is subcontracted to Figliozzi and Company. CMS also has guidance for which documentation hospitals and providers should expect to have available for a Meaningful Use audit.
If you are interested in even more detail than this, we found this article from Hostetler Management Group to be especially helpful as we were researching the qualifications for the flexibility rule, because they specifically quote sections from the final version of the flexibility rule to show what is and is not allowed. We also found that McDermott Will & Emery had an helpful overviews of the OIG auditing program and the CMS auditing program.