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March 06, 2015 12:00 AM

Draft Stage 3 rules for federal EHR program expected soon

Darius Tahir
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    Washington insiders expect the CMS to propose new requirements this month that will include the government's approach to fostering data-sharing in the use of electronic health records.

    In its submission to the White House's Office of Information and Regulatory Affairs, the CMS stated that the program was expected to save Medicare money because eligible providers and hospitals failing to meet the standards would have their reimbursement cut. Benefits stemming from “improved quality of care and better health outcomes,” the submission conceded, “are unable to be quantified at that time.”

    That's problematic, given that's a stated goal for the third stage of the incentive program, which was adopted under the 2009 American Recovery and Reinvestment Act to promote the adoption and meaningful use of EHRs. And it's leading some lawmakers to question the program.

    In a blog post on the website of the journal Health Affairs, a group of Republican senators—John Thune of South Dakota; Lamar Alexander of Tennessee, the chair of the Health, Education, Labor and Pensions Committee; Pat Roberts of Kansas; Richard Burr of North Carolina; and Mike Enzi of Wyoming—questioned whether the investment flowing from the stimulus law was worth it.

    “What have the American people gotten for their $35 billion investment?” they asked. “There is inconclusive evidence that the program has achieved its goals of increasing efficiency, reducing costs, and improving the quality of care.”

    The primary problem behind the mixed success of the stimulus program, they and other critics say, is the lack of data-sharing—or interoperability—between records.

    Dan Haley, vice president of government and regulatory affairs for EHR vendor Athenahealth, said the Stage 3 meaningful-use rules should require the actual sharing of records rather than merely set standards for how to accomplish interoperability.

    “A standard mandate does nothing to spur use of the standard,” Haley said. “The blockages to information-sharing in healthcare aren't technological. They are systemic and financial.”

    For example, Haley said, providers should be able to “see in one place a summary of a patient's longitudinal health history across the entire continuum of care, without the need to sign in to multiple systems.”

    Other critics, meanwhile, have been pressing the agency to chip away at other requirements with the final State 3 regulations. The American Medical Association has asked the agency to abandon the program's “pass/fail" structure, which means even providers who come very close to fulfilling the standards get the same reimbursement penalty as a one who doesn't try at all.

    Stakeholders want to see a variety of new standards imposed on IT vendors in tandem with the new meaningful-use rules. The AMA, for example, wants to see tougher standards around “usability.” A persistent complaint about EHRs is that they take more cognitive effort to use than they should. And, physicians charge, that leads to unsafe results. For example, a mentally tired physician might ignore an alert, or miscalculate the dosage of a drug because the provider believes the prescription is tailored to a different unit of measurement.

    Others want the CMS to add new technological bells and whistles. Pew Charitable Trusts wants to see more support for “unique device identifiers,” which serve as a way to identify and trace specific devices. That allows regulators and public health officials to track specific devices through the healthcare system.

    Another potential new standard for the technology would be the inclusion of “patient-generated health data" from devices like fitness monitors, which may help clinicians track the day-to-day life of a patient in a way that was not previously possible.

    Follow Darius Tahir on Twitter: @dariustahir

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