Smaller EHR Vendors Face Meaningful Use Stage 3 Acid Test

MU stage 3 is so intricate, and the timetable so squeezed, that it could result in the consolidation of the ambulatory EHR healthcare industry.

Chances are, if you're running Epic, Cerner, Allscripts, or one of the bigger EHR technologies, you will get your stage 3-certified software in time to go live by the December 2017 deadline. But if you're running some of the less well-known software out there, it could be a bumpy ride.

The end of 2015 brings the end of the unusual comment period following the issuance of the final stage 3 rules, but perhaps a more important end-of-comment period arrives next week on December 31, when ONC accepts its final public comment on the test scripts for the software to be certified for stage 3 use. This software certification, known as the 2015 Edition, doesn't actually enter use until 2017 (as an option, if the EHR vendor is ready) or 2018 (in mandatory use by all providers).

Last week I spoke with Debra Harris, clinical product manager for AdvancedMD, an EHR aimed at small physician practices, which has been available for 20 years and garnered some good reviews during that time.

"The timeline CMS has set is still aggressive," Harris says. "Twenty-seven months sounds like a lot of time, but based on the objectives and the requirements, that is still unrealistic." Stage 3's emphasis on interoperability, clinical documentation, APIs, and structured data using SNOMED and LOINC terminology are all requirements.

"Realistically, in order for providers to be prepared to demonstrate meaningful use in 2018, vendors have to be certified in early 2017," Harris says. "That only gives a vendor not even a year to put these changes in place."

Lost in much of this timetable are the mounting pressures on small physician practices to upgrade to stage 3 at a time when they are already struggling, and potentially losing revenue, while trying to continue to deploy increasingly sophisticated EHR technology, Harris says.

In short, stage 3 will likely accelerate the consolidation of the ambulatory EHR healthcare industry. I doubt that was CMS' intent, but it looks increasingly like a continuing major effect.

In addition, numerous small practices, frustrated by meaningful use regulations, will simply shut their doors to Medicare patients, limiting the places to which those patients can seek care.

All of this is a continuation of trends started in stage 2, and it's ironic that physicians accepting Medicaid are exempt from meaningful use non-attestation penalties. Patients in dire economic need will continue to have a wide variety of physicians, but the elderly face a declining choice of physicians.

Focusing on Regulation Rather than Innovation

Technology by itself can do little to affect any of these macro-trends right now. And the longer companies such as AdvancedMD are focused on meeting the objectives of meaningful use stage 3, the less true innovation they will be able to bring to EHRs, a software category widely reviled in healthcare right now.

Another complication for companies such as AdvancedMD is that the accrediting bodies that certify software such as theirs to ensure it complies with the multi-hundred-page stage 3 certification requirements are not yet ready to deploy their testing suites yet.

In AdvancedMD's case, they are expecting such testing suites in the second quarter of 2016. "I went through the proposed rule, knowing that most likely the majority of the information in the proposed rule was going to be final, so we already put in place our development in meeting those requirements," Harris says. "APIs, we're good there, for the most part. We've better prepared this time than we have been in the past."

At the same time, some pieces of stage 3 are so intricate, Harris says AdvancedMD really needs two years to do the job right. Instead, it has less than 12 months.

Slowing down the accrediting bodies is the fact that ONC is taking feedback on test scripts through the end of 2015. That means clarifications on the test scripts will get to those accrediting bodies sometime early in 2016, which puts additional time pressure on accrediting bodies.

The HIMSS Electronic Health Record Association (EHRA) is also closely tracking these test scripts. Sasha TerMaat serves on the EHRA Executive Committee and is chair of the organization's Meaningful Use Workgroup. She is also director of certification and regulatory programs for Epic.

I asked TerMaat if the pressures on smaller EHR vendors might ultimately mean fewer EHR vendors, and a more limited choice than providers have today.

"I don't know if that's something that the association has really talked about," she says. "We welcome new members to our association."

As a trade association, EHRA offers its members education, conducted by volunteers, to share expertise on some of the intricate issues surrounding software certification and testing, TerMaat says.

"Also we have opportunities to do joint advocacy, so in items like certification test procedures, where it can be really helpful to listen to someone else say, 'here's what I was thinking about this test procedure,' " she says. "One participant might ask, 'Do you think step 2 really makes sense? Others might say, you know, I didn't think about it when I read it, but I see what you're saying.' That is confusing. If people read it two different ways, we definitely will want them to clarify that, so that the certification process can be efficient.

"Ambiguity, and something that two people could read different ways are definitely something we still watch for really closely, and we highlighted a few examples for ONC to consider clarifying in our feedback on the test procedures."

Until the EHR industry sees ONC's final 2015 Edition test scripts, it won't really be possible to know how EHRs will be evaluated, TerMaat says. But technical guides by HL7, referenced by ONC in its draft specifications, provide some help.

While the larger issues about meaningful use continue to fester, the success of ONC's software certification program will play a significant role in the ultimate success or failure of stage 3. I sympathize with AdvancedMD and its users, trying to survive and thrive in a challenging—perhaps even hostile—regulatory environment.