April 23, 2010 - Advocacy Corner

EHR Oversight Recommended by Policy Committee. Tracking safety errors associated with electronic health records (EHRs) was among recommendations of the Health IT Policy Committee meeting earlier this week. This information, to be tracked through creation of a national database, would be required for Stage Two of meaningful use. To analyze resulting reports and promote lessons learned, the recommendations also calls for the formation of a patient safety organization.

Committee members examined the advisability of having FDA track safety errors. Views differed on the affect such oversight would have on innovation. FDA Center for Devices and Radiological Health Director Jeffrey Shuren added that FDA has the authority to regulate health IT tools but has avoided doing so because EHRs often are connected to other products. Identifying the origin of the error and its relationship to the EHR is complex, particularly in the current stage of EHR maturity.

Opting to encourage innovation, the Committee then voted to: “recommend that the ONC work with the FDA and representatives of patient, clinician, vendor and health care organizations to determine the role that FDA should play to improve the safe use of Certified EHR Technology." In response, ONC’s Dr. David Blumenthal noted that ONC was already meeting with FDA on these issues.

In related news, the FDA recently published reports on adverse events—237 during the past two years--associated with CPOE. These events involved medical ordering software or programs that provide data on recommended drug doses and test results. Given that events were reported voluntarily, it was difficult to determine how often such problems occur.

Among other recommendations, the Committee addressed certification criteria, an issue of concern to providers evaluating their preparedness for meaningful use. The recommendation indicates that: “For each stage, certification criteria should be available at least 18 months prior to the beginning of the eligibility period.” Initially, the recommendation called for finalized criteria 18 months prior.

Additional topics include consideration of “traceability” of interface transactions to trace and analyze the source of problems; inclusion of a feedback button for clinician-users to immediately report any problems/concerns with information that appears on screens; require the RECs to provide HIT-related patient safety report training; and utilize the certification process to ensure that vendors provide safety alerts to their customers for improving patient safety. See the full text for details of the HIT Policy Committee recommendations in a letter addressed to Dr. Blumenthal.

Consumer Groups Urge Strong Meaningful Use Rules. Letters to ONC, CMS and Secretary Sebelius signed by over 50 groups representing seniors, business and family organizations, took issue with industry comments about a “one-size-fits-all” approach of the proposed rules. According to the letter, “assertions that the criteria are a ‘one-size-fits-all’ policy that ignores upfront cost, time and logistical challenges do not reflect the reality of the thoughtfully balanced proposal.” Pointing to the rules, the letter argues that there is sufficient flexibility to meet meaningful use deadlines, including allowing providers to choose the initial payment year and only having to demonstrate meaningful use for 90 days initially.

The groups support the HIT Policy Committee’s recommendation to provide additional flexibility by allowing providers to defer approximately 20 percent of some of the functional criteria. Drawing the line at further flexibility, however, the letter opposes the ability to defer quality measurement, and patient and family engagement or privacy and security requirements. Specific criteria that would be very helpful, continues the letter, are the following: include access to information within 96 hours; summary care records; electronic discharge instructions; an electronic copy of medical record within 48 hours; patient education materials so patients can make sense of and use the information in their record to improve their own outcomes; and reminders for patients to receive appropriate care.

As CMS and ONC weigh these comments and detailed industry input, they must balance legislative intent, practical implementation issues, and impact on patient care among many issues. At the same time, Congress can be expected to convene hearings to solicit feedback from the range of constituents affected by the proposed rules, further complicating the process and perhaps causing delay, adding yet another degree of uncertainty.

AHA Panel to Feature CIO Perspective on Adoption Strategies. Support for a building block approach to meaningful use, changes in the quality reporting requirements, and concern with the basic time compression for spelling out the certification process are all of great concern to CHIME members. In discussing these issues and related concerns of proposed rules at AHA’s Annual Meeting on Monday, Methodist Senior Vice President Pam McNutt will highlight the challenges facing CIOs in qualifying for meaningful use. As Policy Steering Committee Chair and former Advocacy Leadership Team Chair, McNutt is leading a team of CHIME members developing a response to the CMS and ONC proposed rules, the last of which on the Permanent Certification Rule is due May 10. Monday’s panel provides a good opportunity to probe ONC’s thinking on certification with Coordinator Dr. David Blumenthal rounding out the panel discussion.

For an additional discussion with McNutt on the meaningful use criteria, impressions of the proposed certification bodies and testing process, and readiness of vendors and providers, please see the HIStalk Blog of April 20.