Via Electronic Submission @ www.regulations.gov
May 10, 2010
David Blumenthal, M.D., M.P.P.
National Coordinator for Health Information Technology
HHS/Office of the National Coordinator for Health Information Technology Hubert H. Humphrey Building, Suite 729D
200 Independence Avenue, S.W. Washington, D.C. 20201
Dear Dr. Blumenthal:
RE: Proposed Establishment of Certification Programs for Health Information Technology— Permanent Certification Program, RIN 0991-AB59
The Association of American Medical Colleges (AAMC) welcomes this opportunity to comment on the Office of the National Coordinator for Health Information Technology’s (ONC) proposed rule entitled “Proposed Establishment of Certification Programs for Health Information
Technology,” 75 Fed. Reg. 11328 (March 10, 2010). The Association of American Medical Colleges is a not-for-profit association representing all 131 accredited U.S. and 17 accredited Canadian medical schools; nearly 400 major teaching hospitals and health systems, including 68 Department of Veterans Affairs’ medical centers; and nearly 90 academic and scientific
societies. Through these institutions and organizations, the AAMC represents 128,000 faculty members, 75,000 medical students, and 110,000 resident physicians.
The AAMC supports the goal of improving patient care through improved information capture, utilization, and dissemination. Our members are committed to providing high-quality,
coordinated care with the aid of certified electronic health record (EHR) technology. Many academic medical centers have developed their own EHR technology to meet the unique needs of the academic patient care environment. The proposed certification program will greatly affect their use and development of these systems.
The proposed rule for the permanent certification program was developed to support meaningful use as proposed by the Center for Medicare and Medicaid Services (CMS) in “Medicare and Medicaid Programs: Electronic Health Record Incentive Program” (75 Fed. Reg. 1844) and provides the mechanism to evaluate EHRs and EHR Modules based on the certification criteria identified in the interim final rule (IFR) “Health Information Technology: Initial Set of
Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology” (75 Fed. Reg. 2014).
Definition of “Self-Developed” (page 11333)
The proposed rule states that a “self-developed” Complete EHR or EHR Module is one that “has been designed, modified, or created by or under contract for, a person or entity that will assume the total costs for testing and certification and will be a primary user of the Complete EHR or EHR Module.” ONC goes on to state, however, that the term “self-developed” may also refer to a “previously purchased Complete EHR or EHR Module which is subsequently modified by the health care provider or their contractor” to meet certification criteria.
Providers that purchase Complete EHRs and EHR Modules frequently adapt and customize those systems to meet their individual needs. This definition does not indicate the extent of the
modifications a provider may make without requiring the Complete EHR or EHR Module to be certified as a self-developed system. The AAMC requests that the ONC clarify how to
determine when modifications would require a previously-certified vendor EHR Technology to be separately certified.
Permanent Certification Program Application Process for ONC-ACB Status (page 11348-11350)
In the proposed rule, the ONC states that an ONC-ACB will be required to “provide ONC, no less frequently than weekly, a current list of Complete EHRs and/or Modules that have been tested and certified which includes, at a minimum, the vendor name (if applicable), the date certified, product version, the unique certification number or other specific product
identification, and where applicable, the certification criterion or certification criteria to which each EHR Module has been tested and certified.” The AAMC supports this proposal and appreciates the frequency with which this information must be updated. Providers need current knowledge of the state of product certification in the market, and this proposal provides such currency.
Separation of Testing and Accreditation (page 11349)
In the proposed rule, the ONC explains that the permanent certification program will separate the ONC-ACB’s role from the testing process. Testing would be conducted by NIST National Voluntary Laboratory Accreditation Program (NVLAP). The AAMC supports this option, because NVLAP is an internationally recognized testing laboratory accreditation program, and the separation will provide a more transparent process. The integration of NIST in the EHR
technology testing and certification process brings a level of rigor much needed in the HIT market.
Extent and Duration of Revocation under the Permanent Certification Program (pages 11350-11351)
The National Coordinator may revoke an ONC-ACB’s status for committing a violation of law or temporary certification program policies that threaten or significantly undermine the
program’s integrity. If revocation occurs, the ONC proposes that the certification status of improperly certified Complete EHR or EHR Module will remain in effect for 120 days.
Thereafter, the Complete EHR or EHR Module loses its certification, and certification can only be maintained by being re-certified by an ONC-ACB in good standing.
The AAMC has several concerns with this proposal. First, the AAMC believes that the
“certified” status of a Complete EHR or EHR Module should be distinguished clearly from the ONC-ACB’s status as an authorized certification body. Providers should not be put at risk for failing to qualify for HIT incentive payments due to the actions of the ONC-ACB, and EHR products should not lose their certified status without sufficient cause. Complete EHRs and EHR modules should only lose their certified status if there is a real, functional problem with that EHR. The ONC should implement a procedure by which no certification is revoked until the EHR in question is tested for proper functionality.
Second, the AAMC is concerned that 120-days is a very short period. An EHR user who acts in good faith should not be penalized severely for circumstances that are beyond its control. Four months is not nearly enough time for a provider to research, locate, and implement an alternative EHR product, or for a vendor to implement corrections. It is also not clear that another ONC-ACB would be available within 120 days to certify the Complete EHR or EHR Module for which certification was revoked. In a recent situation in which the Food and Drug
Administration (FDA) revoked approval of the STERIS System 1 sterilization product, the FDA gave providers 18 months to transition to legally-marketed alternative devices. The ONC should adopt a similar timeframe here, particularly given the extended length of time and extreme difficulty associated with replacing an EHR system.
Third, the AAMC is concerned about the False Claims Act implications of its certification revocation proposals. In applying for Medicare and Medicaid HIT incentives, providers will attest to the fact that they met program requirements, including the use of a certified EHR. Providers that have a good faith belief that they were using a certified system should not be subject to claims that they violated the False Claims Act, if they discover at a later date that their product was not properly certified. The ONC should not implement a policy that ultimately
would hold providers responsible for the failures on the part an ONC-ACB whose certifying authority was subsequently revoked.
Surveillance Results of Poor-Performing EHR or EHR Module (pages 11349-11350) The ONC requests comment on whether the National Coordinator should take steps such as “de-certifying” complete EHRs or EHR modules, if a pattern of unsatisfactory surveillance results emerges. If through the ONC-ACB surveillance process an EHR technology is discovered not to be performing as expected to meet certification criteria, the AAMC recommends that the ONC not “de-certify” the technology and potentially jeopardize a provider’s compliance with the meaningful use requirements. We raise the same concerns as in “Extent and Duration of
Revocation under the Permanent Certification Program” above, and suggest that the ONC-ACB be required to work with the EHR developer to identify and make corrections within a specified time period. If this is not possible, the ONC-ACB should notify the provider community of the issue, and ONC should provide at least an 18-month period of transition for providers to identify and implement an alternative solution.
Authorized Testing and Certification Methods - Secondary Testing (page 11350)
The proposed rule requires an ONC-ACB to have the capacity to test and certify at its facility as well as through a secondary means or at a secondary location. The AAMC appreciates the ONC’s proposal to require secondary methods of testing and certification including: (1) at the site where the Complete EHR or EHR Module has been developed; (2) at the site where the Complete EHR or EHR Module resides; or (3) remotely. These secondary methods of testing are critical for self-developed as well as currently-installed vendor systems. To require providers with self-developed systems to physically move their EHRs to another location for testing and certification would not only be burdensome but in many cases impossible. The AAMC strongly supports the ONC’s proposal that ONC-ACBs be required to provide secondary testing
opportunities.
Validity of Complete EHR and EHR Module Certification (page 11346-11347)
The proposed rule requires recertification on a two year schedule, based on meaningful use updates. Regardless of year and meaningful use stage at which eligible providers enter the program, certified EHR Technology would have to meet current certification criteria. Providers entering the HIT incentive program in 2013 or 2014 at CMS's "Meaningful Use Stage 1," for example, would thus have to use EHRs certified to the Stage 2 criteria, not Stage 1 criteria. If CMS adopts the proposed staggered approach in the final rule on incentive payment eligibility, requiring a higher bar for the EHR’s capabilities than the provider is required to meet under the
“meaningful use” definition may present an unrealistic goal for some providers, particularly those with self-developed systems.
Two options presented in the proposed rule would assist with the CMS staggered approach and would help throughout the life of the incentive program and beyond. These options are the use of differential certification and requiring recertification only when functional changes need to be made to meet meaningful use requirements. The AAMC supports these proposals as reasonable mechanisms to streamline the certification process and reduce the burden on providers.
The AAMC also encourages CMS to take whatever steps it can to ensure that vendors make clear to purchasers the certification stage of the EHR or EHR Module that is being purchased if, for example, a provider contracts for an EHR or EHR Module in 2012 to meet Stage 1, but by the time implementation occurs Stage 2 criteria must be met.
Additionally, the AAMC is concerned about the ONC’s proposal to require re-certification every time CMS enters a new phase of the meaningful use requirements. A provider’s
properly-certified Complete EHR or EHR Module should remain properly-certified until the meaningful use and standards criteria are changed in a way that would have a direct effect on EHR functionality and capabilities. If CMS simply increases certain percentage reporting requirements, for example, these changes would not require a change to the underlying EHR functionality. For these reasons, the AAMC does not believe a plan for recertification should be tied to a particular calendar year.
Differential Certification (page 11351)
In the proposed rule regarding the permanent certification program, the ONC suggests that ONC-ACBs could certify EHR Technology to the differences between the certification criteria adopted by the Secretary associated with one stage of meaningful use and a subsequent stage of
meaningful use, thereby reducing cost and expediting the certification process. The AAMC supports this approach of differential certification and suggests this method would align with our comments above regarding the limited re-certification of EHR Modules to only functional changes. Both the differential certification and limited re-certification of EHR Modules are in the best interest of providers, because they help avoid unnecessary administrative overhead and allow providers to focus their resources on patient care. The AAMC strongly supports
differential certification to reduce the burden on providers in maintaining their compliance with meaningful use.
Thank you for the opportunity to present our views. We would be happy to work with the ONC on any of the issues discussed above or other topics that involve the academic health center community. If you have questions regarding our comments, please feel free to contact Morgan Passiment at 202-828-0476 or at [email protected].
Sincerely,
Darrell G. Kirch, M.D. President and CEO
cc: Joanne Conroy, M.D., Association of American Medical Colleges Morgan Passiment, Association of American Medical Colleges
