As the Health IT Policy Committee continues to develop the stage 3 meaningful use criteria, providers are questioning the evidence policymakers are using to justify the new regulations.
The November 2012 request for comment on draft stage 3 recommendations, issued by the Health IT Policy Committee (HITPC) and convened by the Office of the National Coordinator for Health IT (ONC) to devise meaningful use policy suggestions, "doesn't have a discussion that would review the literature on these items and provide evidence from pilot studies or discuss the cost versus the benefit," said Chantal Worzala, director of policy at the American Hospital Association (AHA). "It simply says, 'We think we should do this next,' and we think that's a problem."
Worzala said this kind of approach to rulemaking is an issue because it could represent a missed opportunity for the health care system, and could even create risks to patient safety. She said the majority of health care professionals recognize that IT tools, such as electronic health records, have the potential to greatly improve care quality. However, providers need to know for sure that the systems they implement have been proven to produce these benefits.
Policy needs to derive from evidence. A decision to say, 'We'll just ask for comment and see,' is a very different approach than looking at the research, understanding what works and what doesn't work.
director of policy, American Hospital Association
Furthermore, implementing unproven technology could lead to unintended consequences, Worzala said. For example, certain meaningful use criteria require physicians to use their electronic health record (EHR) systems to maintain up-to-date medication lists and use decision support systems to determine medication doses. However, some providers have already seen these systems provide dangerous recommendations, jeopardizing patient safety.
"There are a number of places where [the Health IT Policy Committee] came up with really quite interesting ideas that could be helpful and are absolutely ripe for investigation and development, but perhaps are not yet ready to be a regulatory requirement," Worzala said.
The HITPC plans to continue analyzing the input it received on its request for comment throughout the first quarter of 2013, with specific proposals to follow.
In its response to the HITPC's request for comment, the American College of Physicians (ACP) pointed to specific measures that lack sufficient evidence to support their inclusion. Criteria requiring physicians to implement 15 clinical decision support interventions related to high-priority health conditions, to access imaging results electronically for 10% of patient imaging tests, and to provide electronic summary of care documents in 30% of care transitions all lack sufficient evidence-based justification, according to the ACP's comment letter.
"The concern that the ACP had was that an increasing number of items were being expected for entry and that those were not necessarily clearly associated with the outcomes we're expecting, which are better clinical processes and improved quality of care," Michael Zaroukian, M.D., chair of ACP's medical informatics committee and author of the comment letter, told SearchHealthIT.
He added that many of the measures included in the Health IT Policy Committee's request for comment could leave physicians feeling like they are being required to collect and report data simply to satisfy regulations, rather than as part of an obvious effort to improve treatment outcomes.
An ONC spokesman said in an email to SearchHealthIT that some of the criticism is premature. The request for comment should not be taken as actual policy proposals. The committee will continue to review the comments they received, as well as relevant clinical evidence, before delivering final stage 3 recommendations to the ONC.
But for Zaroukian, the problem of meaningful use criteria lacking a strong basis in evidence didn't just rear its head with the stage 3 request for comment. He said the program's requirements have been drifting in this direction for some time.
He said he and his colleagues had few problems with the stage 1 rules. They were largely based on things that most physicians would agree are good for the patient, such as recording demographic data, allergy information and problem lists. However, stage 2 started pushing requirements into areas where there is less of a consensus, such as requiring physicians to get a certain percentage of patients to access records online. Zaroukian said the ONC showed less willingness to dial back controversial measures in the stage 2 rulemaking process than it did in stage 1. He said he is worried the input of commenters will be even less influential in stage 3.
"Very few of the [stage 2] measures appeared to reflect the input of those who provided comment, so there is a concern going into stage 3 that any input would be taken into a proposed rule," Zaroukian said.
Even if policymakers do consider feedback during the rulemaking process, it still may not be enough to satisfy everyone. Worzala said building consensus among the provider community is not the same as basing policy on verifiable evidence, particularly as the rules start venturing into emerging areas, such as patient engagement and mobile health. Until the meaningful use criteria are based on evidence, Worzala sees the process remaining flawed.
"Policy needs to derive from evidence," she said. "A decision to say, 'We'll just ask for comment and see,' is a very different approach than looking at the research, understanding what works and what doesn't work, looking at the cost versus benefit and making a proposal."