Summary of Proposed Rule Certification Programs for Health Information Technology

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1 Summary of Proposed Rule Certification Programs [RIN 0991-AB59] TABLE OF CONTENTS Introduction... 1 Temporary Testing and Certification Program... 1 Permanent Testing and Cerfication Program... 5 Regulatory Impact Analysis... 6 Health Policy Alternatives, Inc.

2 Summary of Proposed Rule Certification Programs [RIN 0991-AB59] Introduction On March 4, 2010, the Office of the National Coordinator (ONC) for Health Information Technology (HIT) put on public display at the Office of the Federal Register a proposed rule specifying both temporary and permanent programs for testing and certifying electronic health record (EHR) technology. This action came one day after the posting of a different version of the proposed rule (one providing for a Federal Alternative Certification Program), which was subsequently withdrawn. The proposed rule put on public display on March 4 is essentially identical to a version of the proposed rule released by ONC on March 2 nd. The proposed rule is scheduled to be published in the March 10, 2010 issue of the Federal Register (one day later than originally planned). Meaningful use of certified EHR technology is required to qualify for Medicare and Medicaid EHR incentive payments authorized under the American Recovery and Reinvestment Act (ARRA). Comments on the proposed temporary EHR testing and certification program are due by April 9, 2010 (30 days after publication of the proposed rule). Comments on the proposed permanent EHR testing and certification program are due by May 10, 2010 (60 days after publication of the proposed rule). ONC anticipates issuing separate final rules for the temporary and permanent EHR testing and certification programs. Temporary Testing and Certification Program Under the temporary program, EHR testing and certification would be combined and performed by one or more organizations known as ONC-Authorized Testing and Certification Bodies (ONC-ATCBs). The temporary program is seen as a way of making certified EHR technology available more quickly than would be possible under the permanent program. The proposed rule states that testing describes the process used to determine the degree to which a Complete EHR or EHR Module can meet specific, predefined, measurable, quantitative requirements. In contrast, certification describes the assessment (and subsequent assertion) made by an organization,

3 Summary of Proposed Rule Certification Programs P age 2 once it has analyzed the quantitative results rendered from testing along with other qualitative factors, that a Complete EHR or EHR Module has met all of the applicable certification criteria adopted by the Secretary. The proposed rule goes on to state that such qualitative factors could include whether a Complete EHR or EHR Module developer has a quality management system in place, or whether such developer has agreed to policies and conditions associated with being certified (e.g., proper logo usage). ONC proposes to accept and hold all applications for ONC-ATCB status received prior to the final rule effective date and to process these applications in the order in which they are received. ONC assumes that there will be no more than 3 applicants for ONC-ATCB status. Applicants for ONC-ATCB status (which may be a single organization or a consortium of organizations) must request in writing an application from ONC. They may seek approval to test and certify Complete EHRs (including EHR Modules) or solely one or more types of EHR Modules. They will need to demonstrate their conformance to International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC) Guide 65:1996 (Guide 65) and ISO/IEC 17025:2005 (ISO 17025). Guide 65 specifies the general requirements for bodies operating product certification systems and ISO is the international standard that specifies the general requirements for competence of testing and calibration laboratories (how testing should be performed using standard methods, non-standard methods, and laboratory-developed methods). The ONC-ATCB application process would involve two parts, the second of which would involve completion of a proficiency examination to be developed by ONC with assistance from the National Institute of Standards and Technology (NIST). ONC proposes to review and assess part one of an application (and communicate with the applicant regarding deficiencies or matters requiring clarification or minor corrections) and would not review part two until part one is satisfactory. ONC requests public comments on whether ONC-ATCBs should be required to test and certify that any EHR Module from one EHR developer would properly work (i.e., integrate) with another EHR Module from a different EHR developer, and whether ONC should permit ONC-ATCB applicants to seek authorization to test and certify Complete EHRs for use only in the ambulatory or inpatient setting (or require them to test and certify all Complete EHRs, whether designed for ambulatory and/or inpatient settings). ONC proposes that ONC-ATCBs would be required to test and certify all EHR Modules to the privacy and security certification criteria unless one of the following applies: The EHR Modules(s) are presented as a pre-coordinated, integrated bundle of EHR Modules, which could otherwise constitute a Complete

4 Summary of Proposed Rule Certification Programs P age 3 EHR, and which would be tested and certified in the same manner as a Complete EHR (rather than testing and certifying each Module), unless the coordinated bundles of EHR Modules include EHR Module(s) that would not be part of an eligible professional or eligible hospital s local system and under its direct control (e.g., a patient portal EHR Module that is not hosted and maintained). The EHR Module developer demonstrates that it would be technically infeasible for the EHR Module to be tested and certified in accordance with some or all of the privacy and security certification criteria (e.g., in the case of an EHR Module that does not store or maintain any health information). The EHR Module developer demonstrates that the EHR Module is designed to perform a specific privacy and security capability (not all of them). ONC requests public comment on whether there are additional alternatives to the ones proposed above and other circumstances where an EHR Module should be tested and certified to none, some, or all of the privacy and security certification criteria adopted by the Secretary. An ONC-ATCB must have the capacity to test and certify Complete EHRs and/or EHR Modules at its facility and through at least one of the following secondary means: (1) at the physical location where the EHR technology has been developed; (2) at the physical location where the EHR technology resides (e.g., at a hospital); or (3) remotely (i.e., through other means such as through secure electronic transmissions and automated web-based tools, or at a location other than the ONC-ATCB s facilities). For example, ONC expects that an ONC-ATCB would evaluate a hospital s self-developed Complete EHR either at the hospital or remotely. ONC requests public comment on whether an ONC-ATCB should be required to perform any of the secondary methods in addition to testing and certifying EHR technology at its facility. The proposed rule also speaks in more detail about another issue, revisions to code sets previously adopted by the Secretary as a minimum standard (e.g., the Logical Observation Identifiers Names and Codes or LOINC ). ONC describes a process under which the Secretary would determine whether a code set revision is significant and represents a modification, rather than maintenance or a minor update of the code set and consequently, when a code set version should not be permitted for testing and certification above the minimum adopted by the Secretary until additional public comment can be obtained. The proposed rule identifies two methods for undertaking such a determination (which ONC admits are not mutually exclusive): (1) allowing any member of the general public to notify ONC about a new version of an identified minimum standard code set; and (2) having the Secretary proactively identify newly published versions of adopted minimum standard code sets. In either case, the Secretary would make a determination

5 Summary of Proposed Rule Certification Programs P age 4 about the character of the update (whether significant or minor). Further, once the Secretary has granted permission for a new version of an adopted minimum standard code set to be used, any ONC-ATCB may test and certify EHR technology according to the new version, certified EHR technology may be upgraded to comply with the new version without adversely affecting its certification status, and ONC-ATCBs would not be required to test and certify EHR technology according to the new version until the Secretary has updated the incorporation by reference of the adopted version to a newer version. ONC proposes to publish on a quarterly basis any Secretarial determinations that have been made with respect to minimum standard code sets. ONC notes that it is likely that ONC-ATCBs will not exist until May or June 2010 and only if all the requisite regulatory and administrative steps are accomplished efficiently. ONC proposes to make publicly available at the name of each ONC-ATCB, the date each ONC-ATCB was authorized, and the type(s) of testing and certification each ONC-ATCB is authorized to perform. Each ONC-ATCB would also be required to prominently and unambiguously identify on its website and in all marketing and communications statements the scope of its authorization. ONC also intends to make a master certified HIT products list (both Complete EHRs and EHR Modules) available on its website. The proposed rule lays out the circumstances and process under which an ONC-ATCB s status would be revoked by ONC, either for Type-1 violations (that is, violations of law or certification program policies that threaten or significantly undermine the integrity of the certification program) or for failing to respond to, or satisfactorily address, an ONC notification related to a Type-2 violation (that is, inappropriate conduct by an ONC-ATCB, such as failure to attend mandatory ONC training programs, failing to meet specified reporting requirements or misrepresenting the scope of its authorization). The proposed rule also notes that ATCB revocations for Type-1 violations also have the potential for affecting the certification status of EHR technology previously certified by the offending ONC-ATCB. More specifically, if ONC determines that the EHR technology in question has been improperly certified, the certified status of impacted EHR technology would remain intact for 120 days after ONC publishes a notice of its determination. After that period of time, the certification status could only be maintained by having the product re-certified by an ONC-ATCB in good standing. ONC proposes to sunset the temporary certification program when at least one ONC-Authorized Certification Body (ONC-ACB) has been authorized under the permanent testing and certification program (see below). ONC-ATCBs will be able to review any pending applications for EHR testing and certification that they will have received prior to the termination date of the temporary certification program, and complete the certification process for them. ONC requests public comment on whether a specific sunset date, such as 12/31/2011, should be established instead of basing termination on the approval date of the first ONC-ACB. An ONC-ATCB

6 Summary of Proposed Rule Certification Programs P age 5 would be required to retain all records related to the testing and certification of EHR technology for the duration of the temporary certification program and provide copies of these records to ONC at the sunset of the temporary program. Permanent Testing and Cerfication Program Under the permanent program, EHR testing and certification would be separated. NIST, through the National Voluntary Laboratory Accreditation Program (NVLAP), would be responsible for accrediting testing laboratories and determining their competency. Little more is said in the proposed rule about this key component of the permanent program. With respect to EHR certification, ONC would first approve a single accreditor (an ONC-Approved Accreditor or ONC-AA) and assumes that only two organizations would apply to become the ONC-AA. Organizations interested in serving as an ONC-ACB (which may be a single organization or a consortium of organizations) would first have to be accredited by the ONC-AA and then could apply to ONC for designation as an ONC-ACB. And ONC-ACBs would only be permitted to accept test results from NVLAP-accredited testing laboratories when evaluating EHR technology for certification. Applicants for ONC-AA status would have to conform to ISO/IEC 17011: 2004 (ISO 17011), which specifies the general requirements for accreditation bodies accrediting conformity assessment bodies, such as certification bodies (in this case, the ONC-ACBs). ONC-ACBs would be required to conduct surveillance activities (that is, evaluate and reevaluate previously certified EHR technology to determine if such technology performs in an acceptable manner in the field) and to submit an annual surveillance plan to ONC. ONC anticipates issuing annual guidance for ONC-ACBs prior to submission of their annual surveillance plans in order to identify ONC priorities. ONC believes it will take between 8 and 16 months to implement the permanent certification program, and its goal is to have ONC-ACBs authorized under this program by or before the beginning of calendar year 2012 (later in the proposed rule, ONC notes the possibility that they could be authorized as soon as late 2011). ONC estimates that there will be no more than 6 applicants for ONC-ACB status. Many of the proposed policies under the permanent program are the same as or very similar to those discussed above for the temporary program, including provisions relating to privacy and security certification criteria, capacity to use secondary certification means, code set revisions, and certification body

7 Summary of Proposed Rule Certification Programs P age 6 revocation. Similarly, issues on which ONC invites public comment with respect to the temporary program are also relevant for comments on the permanent program. The proposed rule also discusses the issue of differential certification (that is, whether an ONC-ACB could focus only on newly adopted certification criteria when evaluating a previously certified EHR technology rather than the entire set of certification criteria), and invites public comment on whether ONC should require ONC-ACBs to offer differential certification. ONC-AA status would expire after 3 years and would need to be renewed, although ONC invites comments on other possible terms, including 2 or 5 years. An ONC-ACB would be required to renew its status every two years (by submitting a renewal request to ONC 60 days prior to the expiration of its status), and must retain all records related to certification of EHR technology for a minimum of 5 years, which ONC considers to be an industry standard. The proposed rule acknowledges that a single organization (which may comprise subsidiaries or components) could perform both testing and certification functions under the permanent program if it were accredited by an ONC-AA (for certification purposes) and by the NVLAP (for testing purposes). ONC notes that the permanent program could ultimately include the testing and certification of other types and aspects of HIT, such as personal health records and networks designed for the electronic exchange of health information, and invites comment on the need for additional HIT certification. The proposed rule also notes that if certification criteria for HIT beyond EHRs were adopted, a current ONC-ACB would have to submit an addendum to its original application to request authorization to certify this other type of HIT. Regulatory Impact Analysis Much of the regulatory impact analysis focuses on the costs that ONC expects ONC-ATCB, ONC-AA, and ONC-ACB applicants to incur and the Federal costs of processing their applications. ONC believes that about 93 commercially-developed and open source Complete EHRs and 50 EHR Modules will be tested and certified under the proposed temporary certification program. ONC also estimates that about 8 self-developed Complete EHRs or EHR Modules designed for an ambulatory setting (by larger physician group practices) and about 30 hospital-developed Complete EHRs or EHR Modules could be submitted for testing and certification. Under the permanent program, ONC estimates that a total of 167 EHR products would be presented for testing and certification under Stage 2 meaningful use criteria (88 commercial or open source Complete EHRs, 60 commercial or open

8 Summary of Proposed Rule Certification Programs P age 7 source EHR Modules, and 19 self-developed complete EHRs or EHR Modules). Finally, ONC estimates that a total of 170 EHR products would be submitted for testing and certification under Stage 3 meaningful use criteria (84 commercial/open source Complete EHRs, 72 commercial/open source EHR Modules, and 14 self-developed Complete EHRs and EHR Modules). In making these estimates, ONC assumes that Complete EHR developers would continue to consolidate due to mergers and acquisitions, that the cost barrier for EHR Modules to enter the market would be much less than for Complete EHRs, and that the number of eligible professionals and eligible hospitals that incur the testing and certification costs for their self-developed Complete EHRs and/or EHR Modules would fall significantly over time. ONC bases its estimates of the costs of EHR testing and certification on those developed by the Certification Commission (CCHIT). These costs are estimated to range from about $30,000 to $50,000 for Complete EHRs and from about $5,000 to $35,000 per EHR Module.

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