(Reissued with corrections on October 17, 2012)
The rules for both Meaningful Use and the new Standards and Certification Criteria went into effect October 4, after the requisite 30 days since first posting in the Federal Register have passed. The initial flurry of reactions have subsided and interested parties of all stripes are now wrestling with the myriad devils that continue to reside in the details, along with a lot of questions, mainly around Certified EHR Technology (CEHRT).
One certification program ended on October 4; another began. EHRs certified to ONC 2011 Edition criteria by the temporary program or the permanent program, now the ONC HIT Certification Program, can be used until federal fiscal year 2014 for hospitals or calendar year 2014 for eligible providers attesting to Stage 1. EHRs certified to the new 2014 Edition criteria may also be used to attest to Stage 1 but test methods for that program won’t be ready until the end of this year. EHRs certified to the new 2014 Edition must be used whether you are attesting to Stage 1 or Stage 2 in FY/CY 2014. But you won’t need 2014 Edition CEHRT until you start your 90 day attestation period. All of these new rules are relatively confusing for a provider who is focused on caring for patients while attempting to play by the rules. Here are a few key points to guide successful attestations, using appropriately certified EHR technologies.
- If you already have an EHR that was certified to ONC’s 2011 Edition criteria you may use it without changes or upgrades until the 90 day period that you intend to designate as your attestation period for either Stage 1 or Stage 2 in 2014. This means up until July 1, 2014 if you are a hospital or October 1, 2014 if you are an eligible provider. You will, of course, want to upgrade it to the 2014 Edition certification sooner to be sure that you have all appropriate workflows in place by those dates.
- Starting October 4, 2012, health IT companies could continue to apply to certify their EHRs to the 2011 Edition criteria. According to a FAQ (PDF) issued by ONC on October 11, 2012, the implementation of a permanent program requirement that requires public access to both testing results and to some indication of the “total cost of ownership” of that EHR technology has been postponed until testing for 2014 Edition criteria is available. And ONC will only enforce these requirements for EHR technology certified by ONC-ABCs to these new 2014 Edition criteria. When implemented, the price transparency requirement would, for example, require that if a module is certified, the “total cost of ownership” might include interfaces between that module and others that would constitute a “complete” EHR.
- The new process also requires a complete separation between the entity doing the testing and the entity doing the certification. While this “firewall” may exist within one organization, as it does within CCHIT, it is possible for a vendor to go to one organization for testing and another for certification. Note that the ONC authorized Certifying Body (ONC-ACB) is the entity that is responsible for assuring that the products are certified to all of ONC’s requirements.
- A number of EHRs may be piloting direct electronic submission of Clinical Quality Measures to CMS in 2013. This functionality will be required for 2014 Edition EHRs but will not be part of any 2011 Edition certifications.
- The HIT community is awaiting a number of test procedures that will be released by ONC in “waves” and used by all Accredited Testing Laboratories (ATLs) for 2014 certification. Until they are all available, go through a two week public comment period, are revised as appropriate, and released as final, testing and certification to the 2014 Edition cannot begin. It will not begin until vendors have programmed all of the changes and made sure their products are safe and stable.
While some modules, tested and certified to one or a few criteria, may be out soon after the ONC 2014 Edition program is available, it may take several months for robust, fully integrated, EHR systems to have their new 2014 Editions ready for market and even longer to get all existing EHRs upgraded.
- The ONC 2014 Edition itself is quite different from the one currently in use.
- Everyone, eligible Provider or hospital, needs “Base” EHR technology. It can be one product or it can be several products or modules, each certifying to individual or sets of criteria. “Base” EHR includes 8 privacy and security criteria and 9 others including Demographics, Problem Lists, Medication Lists, Medication/Allergy Lists, CPOE, CDS, Data Portability, and 2 criteria for Transitions of Care.
- Depending on intended stage of attestation, everyone will also need either a set of criteria to support core Stage 1 measures or a set of criteria to support the core Stage 2 measures. Again, these can be integrated into a single vendor’s base product or can be purchased as separate modules from multiple vendors which may ultimately need to be interfaced with other modules.
- Everyone will need CEHRT for whatever menu objectives and measures they choose for their attestation as a third consideration.
- While not considered “core,” providers must choose among and are required to report a limited number of Clinical Quality Measures from the 64 possible eligible provider measures, or the 29 possible hospital measures, for successful attestation. The certification process with respect to these measures will include whatever measures the vendor chooses to bring to certification and will be displayed on ONC’s Certified HIT Products List.
- Privacy and security testing will be conducted on the Base EHR criteria only. Of the 15 new criteria, only data portability was included in the base and will thus be tested for privacy and security.
Many questions remain as we await the testing procedures. We will keep you informed as we learn more. In the interim, we are appreciative of the extra time given to all of us — providers, vendors, and testing and certification bodies alike — in the final rule. The 90 day attestation period for FY/CY 2014 should give everyone the time necessary to clarify any remaining questions, program the technology effectively, get it certified, and implement the necessary clinical workflows necessary for successful attestation.
Karen M. Bell, MD, MMS
Chair, Certification Commission
Karen Bell, MD, MMS, is Chair of the Certification Commission for Health Information Technology (CCHIT®. Dr. Bell has wide and varied expertise in health information technology (HIT), quality assurance and clinical practice, in both the private and public sectors. Previously, she served as Senior Vice President, HIT Services, Masspro, the federally-contracted Quality Improvement Organization within Massachusetts, where she oversaw the development, implementation and distribution of products and services to support adoption of electronic health records (EHRs) within the health care system. Between 2005 and 2008, Dr. Bell was Director, Office of Health Information Technology Adoption, Office of the National Coordinator (ONC), U.S. Department of Health and Human Services (HHS), and, in 2006, served as Acting Deputy of ONC. She was ONC’s representative on CCHIT’s Board of Commissioners from 2006 to 2008.
Prior appointments held by Dr. Bell include Division Director, Quality Improvement Group/Office of Standards and Quality for the Centers for Medicare and Medicaid (CMS), and Medical Director of Blue Cross Blue Shield (BCBS) of Rhode Island and of Anthem BCBS of Maine.
She received her medical degree from Tufts University School of Medicine, Boston, and her master of medical science degree from Brown University, Providence, R.I. Dr. Bell has clinical experience as a board certified physician in internal medicine and also was an Associate Professor at the University of Rochester, and Clinical Instructor at Harvard University School of Medicine.