The Office of the National Coordinator for Health Information Technology at HHS will exercise the authority it was given by Congress and expedite the authorization of organizations for the certification of electronic health-records systems under the federal stimulus law.
ONC to expedite EHR certification
The ONC action, which came in the form of a proposed new federal rule released Tuesday, could ease a major bottleneck to a multibillion-dollar federal program to subsidize the purchase of electronic health-record systems by hospitals and office-based physicians under the American Recovery and Reinvestment Act of 2009, also known as the stimulus law.
David Blumenthal, head of the ONC, announced the release of the 184-page rule at the Healthcare Information and Management Systems Society convention in Atlanta. The new rule outlines a bifurcated EHR certification process, one temporary and one permanent. The document is dated Feb. 26.
One prong of the new process would establish one or more entities called an ONC-authorized testing and certification body.
The expedited process could permit EHRs and separate component parts or modules of an EHR to be certified by as early as this summer, according to Steve Posnack, policy analyst for the ONC. The final rule should be published this spring, Posnack said. Organizations seeking to become certification bodies can begin applying for recognition once the final rule is published, he said.
The temporary program would expire in the first quarter of 2012.
It would be replaced by the second prong of the process, according to the new rule, a permanent program in which certification organizations are accredited by an outside agency.
The permanent program would separate the responsibilities for performing testing and certification and also provide for testing of IT systems in addition to EHRs and EHR modules, such as personal health records and health information exchanges.
To be eligible for federal IT subsidy payments under the stimulus law, hospitals and so-called “eligible professionals,” chiefly physicians, must use “certified” EHR systems in a meaningful manner.
On Dec. 30, ONC issued an interim final rule on the EHR certification criteria. That same day, the CMS issued a proposed rule on meaningful use and the steps providers must take to qualify for IT subsidy programs under Medicare and Medicaid.
Two key unanswered questions remained, however, and those were: Who would test and certify EHRs, and, how would these certification organizations themselves be selected?
Under the stimulus law, Congress authorized the national coordinator, in consultation with the director of the National Institute of Standards and Technology, “to keep or recognize a program or programs” for certifying EHRs.
But late last year, Blumenthal declared he would not exercise that statutory authority and keep the Certification Commission for Health Information Technology, the nation's only active EHR testing certification authority, as a certification body under the stimulus law. CCHIT, a not-for-profit organization formed in 2004 at the call of David Brailer, who then headed the ONC. CCHIT has been certifying EHRs since 2006. In August 2006, HHS authorized CCHIT to certify EHR systems under a federal program of exemption from the Stark physician self-referral ban and anti-kickback safe harbor for those hospitals that offer subsidized IT systems to affiliated physicians.
The absence of an HHS-accepted certification body has been an increasingly hot topic of conversation in health IT circles in recent weeks and during the opening days of the HIMSS conference right up to the surprise announcement by Blumenthal on Wednesday.
In fact, Wednesday morning, at a HIMSS conference session with ONC officials, the first question posed to Jodi Daniel, a lawyer who serves as ONC's director of the Office of Policy and Research, was about the lack of an EHR certification program and the delay it could bring to the entire EHR subsidy program.
“We are very cognizant of the timing here and having a certification program up and running,” Daniel said in response.
Questioned later why the ONC hadn't exercised the authority granted to it by Congress to recognize CCHIT as a certification body, at least temporarily, Daniel said HHS was advised by its legal department that it had to go through the formal rulemaking process.
Asked why the ONC hadn't started sooner on the process, Daniel said the two other rules on meaningful use and certification criteria were produced at “fairly record speed.”
“All I can say, we have been working as quickly as possible to get out all of these regulations,” Daniel said.
Later that day, after Blumenthal announced the new rule, Posnack, the ONC policy analyst, said that the temporary rule process, once completed, would supersede the previous HHS recognition of CCHIT for certification of EHRs for Stark and anti-kickback waiver programs.
Under the new rule, an organization seeking to become an ONC-authorized testing and certification body must submit an application to the national coordinator to demonstrate its competency and ability to test and certify complete EHRs and/or EHR modules.
The National Institute of Standards and Technology is developing a method and infrastructure that will be used by testing laboratories in the testing component of both certification programs. The public comment period for the temporary certification program will be open for 30 days after official publication of the new rule in the Federal Register. The public comment period for the permanent certification program will be open for 60 days after publication.
Alisa Ray, CCHIT executive director, said in a prepared statement that “we feel confident about our prospects of becoming accredited,” adding that release of the new rule is “an important step that will reduce the uncertainty that the healthcare community has experienced while awaiting this additional information.”
Alana Ketchel, a consultant working with the California Health and Human Services Agency, who was one of perhaps 500 attendees crammed into a ballroom at the Atlanta convention center to hear Blumenthal, said the new rule “really filed the gap for providers.” Once the certification programs are up and running, providers will know “they'll have a product so they'll be able to get their incentive payments.”
Linda Kloss, CEO of the American Health Information Management Association, said the bifurcated authorization process sounded like a workable scheme “to get this rolling.” CCHIT, she said, “remains committed to contributing.”
Jamie Skipper, president of Skipper Congressional Strategies, a Washington-based policy advisory firm, said “it's encouraging to know this is not in the future now. It's definite. It still remains to be seen how timely the bodies can conform to these criteria and the vendors can meet these criteria to have products ready for their customers.”
Send us a letter
Have an opinion about this story? Click here to submit a Letter to the Editor, and we may publish it in print.