GE Healthcare questions ONC authority to change MU

Agency would get broad powers to review HIT, says firm’s government affairs VP.

A large healthcare information technology vendor has posted an immediate reaction to provisions in a recently proposed federal rule, saying that it would give the Office of the National Coordinator for Health IT more power than Congress had intended.

GE Healthcare filed 35 pages of comments on April 28, only one day after the Centers for Medicare and Medicaid Services published a proposed rule on new Medicare payment processes for physicians.

The proposed rule included suggested changes to the electronic health records meaningful use program, including provisions that would enable ONC to review certified healthcare information technology.

That’s worrisome for GE Healthcare, which instead supports providing more oversight responsibilities to ONC-Authorized Testing Labs that test HIT modules, and offering stakeholders more information about the continued performance of health IT already certified by ONC-Authorized Certification Bodies.

In the rule, ONC says it wants the ability to respond to potential systemic or widespread issues, which could include interoperability and data exchange woes that the agency wants to rectify, as well as problems that pose a risk to public health, safety, security or privacy.

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However, GE Healthcare is concerned that ONC is proposing a substantial increase it its authority that goes beyond what Congress intended in the HITECH Act and is moving toward a separate certification program, says Mark Segal, vice president of government affairs and policy at GE Healthcare IT.

In essence, the company contends that ONC would be able to arbitrarily determine the basis for saying which vendors are out of conformance with its own determination of key rules. That means “we could be responsible for issues with no actual certification criteria,” he contends, adding that ONC is proposing an expansion of its authority without developing new certification criteria.

The big worry is that ONC could suspend or terminate a vendor’s meaningful use for a product, part of a product, or a single quality measure within a product, until a particular issue is fixed.

ONC’s intent is to be able to quickly handle a variety of urgent situations, but GE Healthcare believes that ONC should focus on the most urgent safety concerns of currently certified software “because that’s what they have authority on,” Segal says.

Another worry is ONC’s contention that it can extend its reviews beyond certified capabilities, such as to billing and other revenue cycle management functions. But billing has never been certified, and these types of reviews could result in decertification of an entire EHR, according to GE Healthcare.

While the company believes the goals are laudable, “we just want to make sure there is no overreach of authority,” Segal says.

CMS and ONC published the 962-page rule on April 27, proposing new Medicare payment processes for physicians. It is accepting comments for 60 days on the rule.

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