Will the pace of HIT innovation slow down?

With the future of meaningful use unclear, the path to value-based care uncertain, and the trend to more modular components, EHR and other software vendors re-evaluate their product development plans.

With the future of the meaningful use program up in the air and the industry’s transition to value-based payment rapidly approaching, health IT vendors are caught in middle.

They’re in the unenviable position of trying to anticipate the transformation of the MU program, at the same time working to ensure their products and services enable providers to keep pace with the regulatory changes and succeed in the new healthcare environment.

The impact of changes in the Meaningful Use program trickles down from vendors to the providers, who have to purchase, upgrade infrastructure if needed, test software and implement new changes. Vendor requirements to certify their products with the federal EHR program adds to the time and expense of developing products and getting them to market in time for providers to implement them. Current uncertainty over MU is likely to put vendor programs on hold until details become clearer, and could slow development efforts. More than 3,000 products are now certified for use by providers.

Electronic health record vendors have been particularly challenged by the succession of changes in the federal MU program. They’re on the hook to provide upgrades to customers, who then must be able to adopt new features in a timely fashion to comply with ever-evolving requirements. The uncertainty around where the Electronic Health Record Incentive Program goes from here is perhaps hardest on EHR vendors.

Users are challenging vendors on the inability of their products to meet industry needs, particularly in terms of usability and interoperability. At a January 26 town hall meeting in Seattle, AMA President Steven Stack, MD, complained that EHR technology and vendors "weren’t ready for prime time. [Products] weren’t elegant like they needed to be to allow us to be more effective and efficient in our practice."

Now, changes are looming for the MU program. Earlier this month, Andy Slavitt, acting administrator of the Centers for Medicare and Medicaid Services, declared that MU, "as it has existed, will now be effectively over and replaced with something better." While provider organizations were encouraged by the announcement, it puts new time and development pressures on the vendor community.

Even before Slavitt’s bombshell, the Electronic Health Record Association expressed serious concerns to CMS that substantial changes to meaningful use requirements, as a result of the implementation of the Medicare and CHIP Reauthorization Act (MACRA) and the Merit-Based Incentive Payment System (MIPS), could interrupt the ongoing work of EHR developers and negatively affect the timelines and associated assumptions made by CMS in its final Stage 3 rule.

"EHR developers have already begun development work based on the recent CMS and ONC final rules, which may turn out to be wasted, incomplete or insufficient effort if subsequent regulations or guidance make material changes to underlying needed functionality or measurement criteria for meaningful use," EHRA said in a December 15, 2015, letter to Slavitt as part of its comments on the Stage 3 final rule.

The trade association now is closely monitoring the industry conversation around Slavitt’s recent comments and the follow-up clarification on the future of the meaningful use program offered in a January 19 blog co-authored by Slavitt and National Coordinator for Health IT Karen DeSalvo, MD.

“We’re pleased that CMS is planning to take the opportunity to revisit the meaningful use program within the MACRA proposed rule, as this is a natural time to evaluate what’s working and what needs adjustment to best meet the needs of healthcare professionals and patients,” says Leigh Burchell, EHRA chair and vice president of government affairs for Allscripts.

For vendors, however, the uncertainty around the future of MU affects both them and their customers. "Given that our clients are still obligated to meet Stage 3 obligations and timelines, and we see no likely change to the expansive requirements of the 2015 ONC certification rule affecting our own development efforts, we will be continuing forward at our current rapid pace in order to support our clients," Burchell says.

Federal direction of the program, scant and conflicting as it is, seems to point toward continuation of some aspects of the program, she says, adding that, "We have no doubt that some form of functional requirements, whether as formulated under the existing program or as part of some future version of the program, will continue to be included even as the government moves toward creation and expansion of value-based reimbursement models."

What’s critical is that there is enough time for us to do what we need to do, and for our customers to do what they need to do.For now, EHRA—representing more than 30 vendors supplying the vast majority of EHRs to hospitals and physician practices—is focusing on what is known, namely ONC’s 2015 Edition Health IT Certification Criteria. All providers will be required to comply with MU Stage 3 requirements beginning in 2018, using EHR technology certified to the 2015 Edition final rule that was released in October. The challenge for developers is to quickly understand and interpret the regulatory requirements so that they can focus on product development that meets the aggressive Stage 3 timelines.

“What’s critical is that there is enough time for us to do what we need to do, and for our customers to do what they need to do,” contends Mark Segal, vice president of government and industry affairs for GE Healthcare IT. "If CMS makes major changes to the meaningful use program based on a proposed rule this spring and a final rule next fall, it will be important that they really take into account any additional time that we and other software developers need to make those adjustments."

According to Chris Emper, director of government and industry affairs for NextGen Healthcare, EHR developers need at least 18 to 24 months for development, installation and testing of software to meet requirements for significant rule changes.

However, CMS meaningful use rulemaking notwithstanding, ONC’s 2015 Edition certification rule is set in stone, Emper argues. And having certified healthcare IT is one of the requirements under MIPS for MU Medicare eligible professionals—25 percent of the composite performance score that determines a physician’s penalty or bonus payment will be based on meaningful use of certified EHR technology, Emper adds.

As CMS considers making changes to future meaningful use requirements based on MACRA/MIPS, EHR vendors continue to remain focused on the 2015 Edition certification rule that is tied to Stage 3, which is still slated to begin in 2018. "Until we hear differently, based on that timetable, we’re moving forward," Emper adds.

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