/
ABA Health eSource
April 2010 Volume 6 Number 8

Blumenthal Releases Proposed Certification Rule at HIMSS 2010

By Emily R. Langdon, Esq., Parsonage Vandenack Williams LLC, Omaha, Nebraska

AuthorThe anticipated notice of proposed rulemaking on certification was released by David Blumenthal, M.D., the National Coordinator for Health Information Technology (“National Coordinator”), on March 2, 2010. The release took place at the Healthcare Information & Management Systems Society (“HIMSS”) 2010 annual conference. The certification proposal is one of three rules mandated under the Health Information Technology for Economic and Clinical Health Act (“HITECH Act”), part of the February 17, 2009 American Recovery and Reinvestment Act (“ARRA”).

The certification rule proposes the establishment of two certification programs for purposes of testing and certifying health information technology (“HIT”). 1 The first proposal would establish a temporary certification program in which the National Coordinator would authorize organizations to test and certify Complete electronic health records (“EHRs”) and/or EHR Modules. This would make it possible to obtain the Certified EHR Technology distinction before the date on which health care providers can begin establishing “meaningful use” of Certified EHR Technology.

The second proposal would establish a permanent certification program to replace the temporary program. The permanent certification program would separate the testing and certification duties. It would also institute accreditation requirements, require certification bodies authorized by the National Coordinator to carry out surveillance in regard to Certified EHR Technology, and include the capability for certification bodies authorized by the National Coordinator to certify other types of health information aside from Complete EHR and EHR Modules.

Defined Terminology

Under the proposed rule, “Certified EHR Technology” means a Complete EHR or a combination of EHR Modules, each of which: 1) meets the requirements included in the definition of a Qualified EHR; and 2) has been tested and certified in accordance with the certification program established by the National Coordinator as having met all applicable certification criteria adopted by the Secretary of Health and Human Services (“Secretary”).

“Complete EHR” means EHR technology that has been developed to meet all applicable certification criteria adopted by the Secretary.

“EHR Module” means any service, component, or combination thereof that can meet the requirements of at least one certification criterion established by the Secretary. 2

Incentives and Certification

Title IV, Division B of the HITECH Act establishes incentive programs under Medicare and Medicaid for eligible professionals and eligible hospitals that meaningfully use Certified EHR Technology. The certification programs under the proposed rule are necessary in order to ensure that such eligible professionals and eligible hospitals are able to adopt and apply Certified EHR Technology in their effort to qualify for the meaningful use incentive payments.

The HITECH Act amended section 3001(c)(5) of the Public Health Service Act (“PHSA”) to provide the National Coordinator the authority to establish and maintain a program or programs for the voluntary certification of health information technology that would comply with applicable certification criteria adopted by the Secretary. 3 Such authority provides the basis for the proposed certification rule.

Temporary Certification Program

The temporary certification program sets forth the process by which an organization would become an ONC-Authorized Testing and Certification Body (“ONC-ATCB”). 4 ONC-ATCBs would be authorized under the temporary program to perform both the testing and certification of Complete EHRs and/or EHR Modules. 5 Under the temporary certification program, the National Coordinator would take on many of the responsibilities that other organizations will fulfill once the permanent certification program is implemented.

An organization who wants to become an ONC-ATCB would need to complete and submit an application to the National Coordinator to establish its competency and ability to test and certify Complete EHRs and/or EHR Modules. An organization applying under the temporary program must be able to perform both the testing and certification functions for Complete EHRs and/or EHR Modules. There may be several organizations that qualify and are approved to become ONC-ATCBs.

The National Coordinator has proposed conditions and requirements applicable to the testing and certification of Complete EHRs and EHR Modules. Under the temporary program, the National Coordinator would accept applications to become an ONC-ATCB any time. The temporary certification program would sunset as soon as the permanent certification program is established and the National Coordinator has authorized at least one certification body.

Permanent Certification Program

Under the permanent certification program, several of the duties and responsibilities taken on by the National Coordinator under the temporary certification program would be assumed by other organizations. The National Coordinator would attempt to move many of the temporary certification program’s processes to the private sector, as appropriate. The permanent certification program sets forth the process by which an organization would apply for and become authorized as an ONC-Authorized Certification Body (“ONC-ACB”). 6 The authorization to become an ONC-ACB would be valid only for certification. Such authorization would not be valid for testing. Also, an applicant for ONC-ACB status must be accredited before submitting an application to the National Coordinator. 7

Accreditation would also be required for testing organizations under the permanent certification program. The National Coordinator’s authorization would no longer be valid for purposes of testing Complete EHRs and EHR Modules. Rather, the National Institute of Standards and Technology (“NIST”) would be responsible for accrediting testing laboratories and assessing their competency through the National Voluntary Laboratory Accreditation Program (“NVLAP”). 8 The NIST would be the only organization responsible for supervising activities related to testing laboratories. Under the permanent certification program, ONC-ACBs would only be allowed to accept test results from NVLAP-accredited testing laboratories during their evaluation process for certification of Complete EHRs and EHR Modules.

As is the case for the temporary certification program, the National Coordinator has also proposed conditions and requirements that would apply to the certification of Complete EHRs and EHR Modules in the permanent certification program. However, unlike the temporary certification program, the permanent certification program would require ONC-ACBs to renew their status every two years. 9

Distinction between Testing and Certification

 It is important to clarify the distinction between “testing” and “certification” for purposes of the proposed certification programs. In the proposed rule, “testing” means the process used to assess the degree to which a Complete EHR or EHR Module can meet predefined, quantitative requirements. Such results would be able to be compared and evaluated according to predefined measures.

On the other hand, “certification” means the assessment and declaration made by an organization once it has analyzed the quantitative results obtained from testing in conjunction with other qualitative factors, that a Complete EHR or EHR Module has met all of the applicable certification criteria adopted by the Secretary. Examples of qualitative factors could be whether a Complete EHR or EHR Module developer has implemented a quality management system, or whether the Complete EHR or EHR Module developer has consented to the policies and conditions associated with being certified (i.e., proper usage of a logo). Certification goes beyond testing and normally promotes confidence in the quality of a product and the vendor that produced such product. Moreover, certification provides assurance that the product will perform as described, and makes it easier for EHR consumers to distinguish products that have met specific criteria from those that have not.

Accreditation

 The National Coordinator has proposed that ONC-ATCBs under the temporary certification program would be authorized and required to carry out both the testing and certification of Complete EHRs and/or EHR Modules to achieve timelier certification at the program’s onset. The National Coordinator would take on a position similar to an accreditor and would analyze an ONC-ATCB applicant’s competency to perform both testing and certification before granting the applicant the ONC-ATCB status.

However, under the permanent certification program, the accreditation responsibilities would be shifted to other organizations in the private sector who are better equipped to respond effectively and efficiently to changes in the HIT market and who would have the ability to more scrupulously oversee the certification bodies they accredit.

In order for an applicant to become an ONC-ACB under the permanent certification program, it would need to be accredited by an “ONC-Approved Accreditor” (“ONC-AA”) for certification. 10 The accreditation requirement is in addition to meeting the National Coordinator’s other proposed application requirements. Accordingly, the proposed certification rule contains a process whereby accreditation organizations can request approval to become an ONC-AA. 11

Comments on the Proposed Rule

During the release of the proposed rule, Blumenthal emphasized the need for HIT leaders to step forward and provide feedback for the proposed rules. The document includes questions directed at HIT leaders and requests for feedback. “We want you to continue to be leaders and we will follow your lead,” he said. The release of the proposed rule shifts the HIT focus from policy to moving forward with the process of implementation.

Interested parties will have 30 days after the proposed rule’s publication in the Federal Register to comment on the proposed temporary certification program, and 60 days to comment on the proposed permanent certification program. The 30-day comment period on the temporary certification ends April 9, 2010, while the 60-day comment period for the permanent certification proposal will end May 10, 2010.

Comments may be submitted electronically at www.regulations.gov .


1 Dept. of Health and Human Services, Proposed Rule for 45 CFR Part 170, RIN 0991-AB59 (Feb. 25, 2010) (“Proposed Rule”).
2 Terms as defined in 45 CFR § 170.102.
3 Title XIII of Division A and Title IV of Division B of ARRA (Pub. L. 111–5). The HITECH Act amended the PHSA and created “Title XXX – Health Information Technology and Quality” (“Title XXX”) to improve health care quality, safety, and efficiency through the promotion of HIT and electronic health information exchange.
4 Proposed Rule 45 CFR § 170.401.
5 Proposed Rule 45 CFR § 170.402.
6 Proposed Rule 45 CFR § 170.501. It is important to note that an “ONC-ACB” in the permanent certification program is different than an “ONC-ATCB” in the temporary certification program.
7 Proposed Rule 45 CFR § 170.520(c).
8 Such accreditation would be made in accordance with section 13201(b) of the HITECH Act.
9 Proposed Rule 45 CFR § 170.540(c).
10 Proposed Rule 45 CFR § 170.520(c).
11 Proposed Rule 45 CFR § 170.503.

The ABA Health eSource is distributed automatically to members of the ABA Health Law Section . Please feel free to forward it! Non-members may also sign up to receive the ABA Health eSource.