With the clock running toward the start of a tougher stage of the electronic health-record incentive program, the government is struggling to hold up its end on testing and certifying the next generation of EHRs.
The federal incentive program, created under the American Recovery and Reinvestment Act of 2009, has doled out $10.7 billion to more than 190,000 hospitals, physicians and other eligible professionals. But the stimulus law called for HHS to dial up the rigor of the program over time. The more stringent Stage 2 meaningful-use criteria go into effect Oct. 1, 2013, for hospitals and Jan. 1, 2014, for physicians and other professionals. Stage 2 applies to those providers that have been paid for at least two years, and possibly three, at Stage 1.
“We're a little more than nine months away,” warned Michele “Mickey” McGlynn, chair of the Electronic Health Record Association, an affiliate of the Healthcare Information and Management Systems Society. McGlynn said her group's 41 members, makers of EHRs for hospitals and office-based physicians, are being stymied by the programmatic glitches. “Our customers are soliciting our help on a daily basis,” she said.
On Jan. 22, the trade group sent the Office of the National Coordinator for Health Information Technology an eight-page letter detailing technical problems with the ONC-led EHR testing and certification regime. To press the urgency, the association asked ONC to reply in five days.
The letter said software developers can't get their systems approved for use in Stage 2. That's because the EHRs can't be tested and certified against the 2014 Edition Certification Criteria. Compliance with the 2014 Edition criteria indicates that an EHR has the right stuff to enable providers to meet their meaningful use targets under Stage 2. But the five ONC-approved independent testing and certification bodies can't do their jobs because several essential testing “tools”—custom-made software programs government contractors developed for the ONC—have not been completely debugged.
The EHRA letter focuses on a tool called Cypress, for use in testing EHRs on the accuracy of their calculations of Stage 2 clinical quality measures. The letter also touches on some buggy, faux patient data used in the testing process. The EHRA letter called Cypress “insufficient,” saying the data, if used, “would lead to inaccurate test results.”
“All of those things are hindering our ability to do what we should be doing, helping our customers understand what they have to do and developing our software and getting it into their hands,” said McGlynn, senior director of strategy and operations at Siemens Healthcare, Health Services.
In the EHRA letter, signed by McGlynn and seven other association leaders, they say the issues threaten the timely certification of quality measures for their products. The association asked that either testing for certification go forward without Cypress, or that the ONC and the CMS “fix the identified errors and the test data, and employ a thorough quality assurance, validation process to ensure its readiness.”
On Jan. 23, Carol Bean, director of the ONC's certification office, sent a memo to the testing and certification bodies, acknowledging problems with a different tool, the program's Transport Test Tool. That tool, developed for ONC with help from the National Institute of Standards and Technology, is designed to test EHRs on Stage 2 requirements for exchange of patient-care summaries and other secure messages, important first steps under the program in a long march toward EHR interoperability.
“They need more help with that than they've gotten so far, and we're trying to respond to that request with documentation, technical assistance, training and webinars,” Bean said in an interview.
The government earlier pushed back several deadlines for compliance with technological standards, including a one-year delay, already in place, on the start of Stage 2.
Asked whether the ONC is considering another delay, Bean said, “These dates are set in legislation and regulation, and we're trying to do everything we can” to meet the current timeline.