The Department of Health and Human Services has sent to the Federal Register two notices of proposed rulemaking for Stage 2 of the electronic health records meaningful use program. The rules will be available on Feb. 23 on the Federal Register Public Inspection Desk, and within days officially published.

The proposed rules have a 60-day public comment period following publication. Federal officials hope to publish final rules in mid-summer. One rule sets the policies and criteria for achieving Stage 2 meaningful use; the other rule would adopt standards, implementation specifications and certification criteria to ensure EHRs support Stage 2 objectives.

National HIT Coordinator Farzad Mostashari, M.D., says the main message in Stage 2 proposed rules is “stay the course.” Much of the meaningful use objectives in Stage 2 are familiar, as the Office of the National Coordinator adopted recommendations of the HIT Policy and Standards advisory committees “in very very large part,” he notes.

But there are significant changes and new flexibility in the proposed rules, compared with the Stage 1 meaningful use program. Stage 2 includes specific emphasis on data exchange, Mostashari says. “We can’t wait five years to get standards-based exchange.” That goal, he adds, will be reached when the next phase of meaningful use starts in October 2013 for hospitals and January 2014 for eligible professionals. The proposed rules require use of the Direct Project protocols for secure e-mail, although optional certification of the SOAP approach is permitted. There are specific standards--no longer a menu of options--for lab results and vocabulary.

Further, demonstrating compliance with data exchange means the actual exchange of data across organization and vendor boundaries. That means sending a summary of care to a recipient with no organizational affiliation for more than 10 percent of referrals and transitions of care.

Other significant areas of emphasis in Stage 2 cover patient engagement and patient safety, particularly on medication management, with required levels of use of an electronic medication administration record. On engagement, for instance, patients must have the ability to view, download and transmit their records, and the certified EHR must support secure messaging among patients and providers.

But the proposed rule also demonstrates a commitment to President Obama’s executive order that government agencies reduce regulatory burdens and increase flexibility wherever possible, Mostashari says. For example, the proposal for “gap certification” means EHR vendors only need to get new capabilities mandated under stage 2 certified. They do not have to recertify existing capabilities already certified under Stage 1. A new provision, which received loud applause, is that providers don’t have to buy a new EHR that includes functions not covered under meaningful use. They can meet meaningful use by using a Complete EHR, a modular EHR or a combination of Modular EHRs.

Clinical quality measures in Stage 2 will align with other reporting programs, including, among others, PQRS, ACOs, medical homes, NCQA and Joint Commission. Group reporting of quality measures--not individual but including all physicians in a practice, for instance--is permitted under the proposed rule.

Stage 2 as proposed includes 17 core objectives and three of five new menu objectives for eligible professionals, and 16 core objectives with two of four new menu objectives for hospitals.

Other objectives and provisions in the proposed rules for Stage 2 include:

* Ongoing electronic submission of public health reporting when departments can accept it;

* The viewing of images as an optional menu objective;

* More than 50 percent of patients being provided access to a summary of their treatment within four days with more than 10 percent of patients actually viewing, downloading or transmitting the information;

* More than 40 percent of diagnostic medical scans and images being accessed through certified EHR technology as a menu objective;

* Electronically submitting to a cancer or specialty registry as a menu objective; and

* Secure messaging of ambulatory physician notes as a new objective.




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