June 2014

Vendors Vent MU Frustrations
By Juliann Schaeffer
For The Record
Vol. 26 No. 6 P. 20

The mere mention of the stage 2 criteria may be enough to raise heart rates, but proponents say the higher standards should be welcomed.

Providers nationwide have been vocal with their complaints about integrating the federal meaningful use (MU) regulations into their daily routine for stage 1 (and now stage 2) attestation, with workflow-related concerns topping the list for many. However, EHR vendors also may be feeling some fatigue related to all the research, time, and resources required to update their products as they pursue testing and certification for the 2014 edition criteria.

Despite the ICD-10 deadline being pushed back, some vendors are making known their frustrations that there’s too much to do and not enough time to accomplish everything. But while easing the stage 2 timeline or requirements may appease certain vendors, would it be in the best of interest of patients? And what repercussions would changes have on patient care?

According to at least one vendor, as the Office of the National Coordinator for Health Information Technology (ONC) raises the bar by updating certification criteria, the process will weed out poorly constructed or ill-prepared EHR products from the market, which could end up benefiting patients more than anyone else.

The final rule with specifics of what will be necessary for eligible professionals, eligible hospitals, and critical access hospitals to attest for stage 2 MU was published in the Federal Register on September 4, 2012, with the Centers for Medicare & Medicaid Services (CMS) releasing a revised timeline in December 2013 with some extra wiggle room. “Under the revised timeline, stage 2 will be extended through 2016,” says Anthony Gil, director of EMR product management for Lumeris.

Despite the advance notice, some EHR vendors have been humbled by the scope of the MU program, says Amit Trivedi, program manager for health care for ICSA Labs, an ONC-authorized certification body, who adds that the huge undertaking is bound to breed at least some frustration.

“It is important to recognize the distinct components to the MU program,” he says. “You can categorize them as a technology component, including testing health IT products to ONC certification criteria, and a behavioral component, which is attestation by providers to CMS MU requirements and performing them on certified HIT products that they have implemented. When we begin to talk about frustration, in a large, complex project of this scope of health care reformation/transformation, there are bound to be many frustrated parties. There are many moving pieces, from the regulatory bodies to those administering the program to product vendors, purchasers, users, and patients.”

While certification may be daunting, Michael Brozino, president and CEO of simplifyMD, has little sympathy for EHR vendors that are behind the eight ball and crying foul. “Since we’re more than a quarter of the way through 2014, vendors should have already completed certification for meaningful use stage 2 [2014], as simplifyMD did earlier this year,” he says.

Because vendors had less time to prepare their products for 2014 MU certification testing than they did for stage 1, Brozino believes only the best will survive. “[The faster turnaround] is turning out to have a positive impact on the market because it is helping shake out the vendors that offer substandard EHR products,” he says. “Due to the less challenging requirements and added testing allowed for stage 1 certification, many vendors that never should have released their products on the market ended up earning certification. These vendors are learning through the 2014 certification update and testing that insufficient design and quality won’t be tolerated in the market anymore.”

Breaking Down Stage 2
One key factor in stage 2 is the data exchange requirements. “Stage 2 promotes interoperability by being able to securely share clinical data between practices,” Brozino says. “The goal is to establish a standard format. Further, patient interaction and engagement is a big push with stage 2. The regulations state that practices need to allow patients to connect with their care provider via secure patient portal and better tracking [of] their medications, labs and imaging orders, and results. The goal is to make the patient own and understand their health.”

“Along with the two main upgrades around patient engagement and education measures as well as electronically exchanging summary of care through standards-based interoperability, stage 2 also calls for an expansion of the use of clinical decision support tied to at least five clinical quality measures,” says Justin Barnes, vice president of industry and government affairs for Greenway Health and chairman emeritus of the Electronic Health Record Association.

“Incorporating lab results into the EHR as structured data has also become a core item in stage 2,” he continues. “Another functionality expansion in stage 2 is the rise of sending data to public health agencies and specific registries. In this instance, four measures divided between core and menu items are in the final rule. Certainly, sending data to public health and other registries is a function of interoperability, and here, too, health IT platforms need to incorporate and offer standards-driven data exchange.”

Whereas stage 1 was about capturing data in electronic format, Trivedi says stage 2 is more about the exchange of clinical data in an electronic format. “Stage 2 meaningful use is primarily focused on the advancement of clinical processes, which includes more rigorous health information exchange, increased requirements for ePrescribing and the incorporation of laboratory data, electronic transmission of patient care summaries across multiple settings, and a focus on more patient-controlled data,” Gil says.

2014 Edition Certification Process
Every company’s road to EHR certification for stage 2 will be unique, but Trivedi says all of them likely will keep the following phases in mind:

• product development, which encompasses the time it takes to review and understand the criteria, develop and test new functionality, and allocate resources for testing/certification;

• the sales cycle, including the time to market and promote the certified product; and

• the implementation cycle, which involves product selection, licensing and contracting, the implementation itself, and training.

“Stage 2 raises the bar in a number of areas, most notably the interoperability testing requirements,” Trivedi says. “There are some more robust requirements around vendor attestation that are also important to consider. Some of the attestation, like providing usability reports, takes time to develop and is not as simple as filling out a questionnaire. Since stage 2 focuses on data exchange, 2014 edition criteria focus on transport and specific message implementations for exchanging immunization information, public health reporting information, electronic prescriptions, lab results reports, and patient summaries.”

simplifyMD began by scouring the stage 2 specifics. “The first step in updating our product for 2014 certification was to review and analyze the highly detailed specifications published by the ONC and then follow the process described in the specifications,” Brozino says.

Next up was meeting with HIT consultants, who provided insight into the best way forward. During this time, Brozino says the company also gained customer input. “We surveyed our customers to determine which clinical quality measures they intended to capture for their stage 2 attestation,” he says. “Due to our diverse user base, we ended up selecting 25 clinical quality measures to certify against during our testing.”

Finally, after putting all the professional and provider insight into action, simplifyMD selected ICSA Labs to certify its product, an arduous process, according to Brozino. “An EHR system either satisfies all the certification criteria or fails—there is no grading scale,” he says. “Earning 2014 certification demanded a large time investment in 2013, and we devoted a significant amount of financial and personnel resources to the process.”

There was some flexibility around gap analysis built into stage 2 certification. And since many of the 17 core eligible professional measures remained in place from stage 1, albeit with increased percentages or threshold reporting, Barnes says the functionality already was in place for those criteria. “That, and the timeline extension of stage 1 as the stage 2 requirements were being finalized, allowed for time to focus on the best practices and options we saw to provide a low impact on provider workflows, which is a very important mindset to have going into meaningful use functionality,” he says.

In pursuit of 2014 certification, Greenway Health considered not only the specific requirements on its end but also what was necessary for provider attestation, particularly with regards to security. “And while this is an example of a specific MU requirement, it is also indicative of the future functionality assessments leading health IT suppliers need to advance around data security and patient safety,” Barnes says.

When it comes to data security, Barnes says EHR vendors should be looking at both meeting specific requirements and advancing collaborative and long-term security and safety solutions. “Whether it’s through certification, postmarket surveillance, or a combination, leading health IT firms will need to work with their provider and health care organization customers to collaborate on risk-based assessments to anticipate or meet requirements beyond meaningful use for patient safety and patient data security,” he adds.

Trivedi agrees, adding that health care leaders should think big. “Vendors should remember that certification requirements are a baseline, or minimum requirements necessary,” he says. “The best vendors and system developers will always be looking to go above and beyond to develop robust systems that anticipate their customers’ needs.”

Because stage 2 certification required such a large investment in development, simplifyMD decided to change how it introduced product updates. “Prior to stage 2, our release schedule was to deliver product updates to our customers approximately every 90 days,” Brozino says. “Due to the development demands of reconfiguring our technology for 2014 certification, we instead released a much larger annual upgrade to customers that included all the value-added product improvements we had developed over the year plus all the modifications necessary to successfully attest to stage 2 meaningful use.”

Vendor Thoughts
At ICSA Labs, the biggest challenge has been convincing EHR vendors that their products must meet all requirements regardless of whether they’ve been requested by customers. “Usually, many product updates are driven by customer requests and some measure of development efforts to return on investment,” Trivedi says. “In many cases, the requirements serve a specific purpose, whether it is incorporating a terminology or standard to facilitate data exchange or supporting a requirement for meaningful use. It can, however, be frustrating when a requirement doesn’t seem to apply to a population. It’s difficult to manage a one-size-fits-all approach with certification criteria.”

He says the ONC has made an effort to allow for flexibility and innovation while still trying to keep the end goal in sight, which is revamping the nationwide health care delivery system through HIT.

Vendor frustrations may echo providers’ biggest complaints about attesting for MU, especially when it comes to the amount of time and resources that must be devoted to the cause. However, progress is being made. “At the start of the 2014 edition program, there were some delays with test scripts and tools, but the process is fairly well-defined now and for the most part runs smoothly,” Trivedi says. “It is not easy, however, so for those vendors that are not keeping close track of things, it can be a shock in terms of the development efforts to meet the 2014 edition requirements.

“It is clearly a competitive advantage to stay engaged in the certification and testing process as it is being developed, and there are a number of forums to do that,” he adds, citing public comments, federal advisory committee meetings, and standards workgroups as valuable resources. In fact, the Health IT Policy Committee’s certification/adoption work group is scheduled to meet July 8 to discuss changes to the 2015 edition of certification criteria.

Gil notes that stage 2 requirements are more comprehensive than the preceding version, and preparing for ICD-10 (the most recent delay notwithstanding) doesn’t help matters. “The fact that we have back-to-back hurdles to overcome with meaningful use stage 2 requirements and ICD-10 is a lot to digest all at once,” he says.

A few aspects of stage 2 are proving to be tricky, Trivedi says. “Certain criteria, like those around clinical quality measures, have always been difficult requirements,” he notes. “A number of vendors are struggling with the attestation requirements and some of the prerequisite tasks that need to be completed prior to completing certification.”

Lumeris found the safety-enhanced requirements to be particularly cumbersome, primarily due to the lack of information provided about user-centered design practice.

According to Brozino, the biggest frustration among vendors that have completed stage 2 of 2014 certification is not with the guidelines “but rather with the other vendors who are now begging the government for more time so they can figure out how to certify their product.” He has little patience for vendors that “have the nerve to ask their own customers for patience because the system they created is a shoddy product that the vendor either doesn’t know how or isn’t willing to spend the money to fix.”

Further delay to the current certification timelines would be unnecessary, Brozino says, noting that EHR vendors serious about improving patient care will put in the time and resources necessary to update their product. Eventually, the diligent will be rewarded. “What we’re seeing right now is a shakeout of the products delivered by vendors who are failing to meet the needs of the market,” he says. “This is how this situation should resolve itself, not with an unnecessary government-imposed delay.”

Brozino realizes that the 2014 certification process was not easy, but if vendors had any specific problems, they had every chance to voice their concerns after the requirements were released. “A time comes, however, when they need to stop complaining and get to work,” he says. “That time passed months ago.”

While it’s difficult to predict vendor frustration levels, Trivedi says those struggling with the requirements may not have had time to supply public comments or help develop and validate test procedures and tools. “There is a tremendous amount of stakeholder feedback that is solicited and taken into account. That being said, it was predictable that vendors were going to struggle meeting the certification requirements initially, and there would be delays implementing systems,” he says. “There were extensions to the stage 2 timeline to help relieve some of those pressures, just like stage 1.”

For vendors struggling to update their EHR products for stage 2, Trivedi recommends seeking help sooner rather than later, even before they’re ready for testing. “If you know you are going to have your product certified, find an authorized certification body and accredited test lab to work with as early in the process as possible, as they can provide specific guidance,” he says.

Besides testing, ICSA Labs focuses on preparing vendors for the test itself, making sure all the requirements are clear and understood so that there are no surprises. “Many vendors delay working with a lab until they work out the requirements on their own, only to realize they have strayed far along the wrong path,” Trivedi says. “Working with an experienced test lab and certification body can save a lot of extra time and resources.”

With the CMS extending the attestation deadline until 2016, there’s still time for vendors to take the stage 2 leap. According to Gil, easing the requirements now would delay the significant benefits that the health care system is set to achieve when providers implement stage 2. “Allowing systems to communicate is a huge step forward and is a vital component in the patient’s transition of care, which leads to better care coordination,” he says.

Trivedi, who says frustration is part of the process, recommends vendors keep their eyes on the target, a strategy that will benefit them as well as the health care system as a whole. “Stage 2 is just starting, so we are not even at the halfway point yet,” he says. “In my opinion, there is no reason to ease any of the requirements. It is important to stay the course but at the same time listen to stakeholder feedback and concerns. There will always be a certain amount of frustration when navigating change on this scale. Keep the end goals in sight, as there has been tremendous progress made in the last few years.”

— Juliann Schaeffer is a freelance writer and editor based in Alburtis, Pennsylvania.