ID: HHS-OS / RIN: 0991-AB92)

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1 April 24, 2014 Attention: 2015 Edition EHR Standards and Certification Criteria Proposed Rule Office of the National Coordinator for Health Information Technology Department of Health and Human Services Hubert H. Humphrey Building 200 Independence Ave. SW., Suite 729D, Washington, DC Subject: (Docket ID: HHS-OS / RIN: 0991-AB92) Voluntary 2015 Edition Electronic Health Record Certification Criteria: Interoperability Updates and Regulatory Improvements; Comments of the American College of Radiology On behalf of the American College of Radiology (ACR) a professional organization representing more than 35,000 radiologists, radiation oncologists, interventional radiologists, nuclear medicine physicians, and medical physicists we appreciate the opportunity to comment on the Office of the National Coordinator for HIT s (ONC) February 26, 2014 Notice of Proposed Rulemaking (NPRM) regarding the potential voluntary 2015 Edition EHR certification criteria and future considerations for the 2017 Edition. The following comments were compiled by ACR s IT and Informatics Committee-Government Relations Subcommittee. General Comments Complete EHR Product Certification Status The ACR supports ONC s proposal to eliminate the concept of Complete EHR certification status for products beginning with the 2015 Edition EHR certification criteria. We believe that modular certification of functionality is better suited to the regulatory definition of certified EHR technology (CEHRT) given the relatively recent flexibility added by the 2014 Edition final rule. We agree with ONC that having different certification statuses for Complete EHRs and EHR Modules does not correlate with the current CEHRT paradigm and likely leads to confusion. Base EHR Definition The ACR generally supports limiting the regulatory Base EHR definition to any criteria that represent the minimum EHR technology functionality required by law. We therefore support ONC s proposal to only require in the Base EHR definition the 2015 Edition CPOE criteria that correspond with the CPOE order types the EP needs. However, we are concerned that EPs would still need to cover at least one CPOE certification criterion even if those EPs are excluded by CMS from all three CPOE types. We understand that the underlying statute explicitly requires some manner of CPOE functionality in CEHRT, and that the Base EHR definition was more or less designed to reflect the minimum requirements in the statute. Our recommendation, therefore, is

2 that ONC offer an alternative/substitute CPOE certification criterion for functionality that supports recipients of orders, such as the ability to document received radiology/imaging orders from referring providers in CEHRT. Certified EHR Technology Definition The ACR supports ONC s proposal to allow eligible professionals (EPs) to use any combination of 2014 Edition and 2015 Edition EHR certification criteria to satisfy the regulatory definition of CEHRT. We believe that this proposal, combined with the recent flexibility in the CEHRT definition, would provide optimal customizability for program participants. Proposed 2015 Edition EHR Certification Criteria (a)(3) - Computerized Physician Order Entry (CPOE) - Radiology/Imaging The ACR has long recommended, and strongly supports, ONC s proposal to separate the order types in the previous CPOE certification criterion into three distinct certification criteria (medications, lab-tests, and radiology/imaging). A standalone certification criterion for CPOE of radiology/imaging will allow more specialized, robust order entry software to achieve modular certification for use in the EHR Incentive Program without having to add unrelated medication and lab-test ordering functionality. Additionally, the ACR continues to recommend that ONC explicitly require radiology/imaging order entry functionality to integrate appropriateness criteria-guided clinical decision support (CDS) for radiology/imaging orders. The CDS should be based on authoritative specialty society appropriateness guidelines, such as ACR Appropriateness Criteria ( ACR s Appropriateness Criteria guidelines are electronically specified and provided via web services for inclusion in EHR technology (see ACR Select for more information - Real world implementation has shown that robust radiology/imaging order entry systems with ACR Appropriateness Criteria-based CDS reduce inappropriate ordering behaviors, thereby improving patient safety (e.g. by reducing radiation exposure to patients), eliminating waste, and reducing health care costs. Moreover, provisions in the recently passed Protecting Access to Medicare Act of 2014 (H.R. 4302) will soon require health care providers to use said functionality for reimbursement of ordered imaging services. Finally, while we understand radiology/imaging CPOE in the EHR Incentive Program is currently focused on documentation within CEHRT, and not transmission of orders to the rendering provider, the ACR believes that future CPOE functionality should eventually be required to provide the rendering provider with a structured indication/reason for the order. The ACR is soon releasing a terminology set for radiology exams and indications, called ACR Commons, which could be leveraged for this purpose (a)(10) - Clinical Decision Support The ACR supports the end objective of the Health edecisions initiative, and we want to collaborate with ONC to include the relevant use cases needed to connect radiology/imaging appropriateness criteria CDS with the CPOE process. 2

3 As mentioned in our comments on the proposed certification criterion for radiology/imaging CPOE, ACR s Appropriateness Criteria guidelines are electronically specified and provided via web services for seamless inclusion in EHR technology (see ACR Select for more information - Moreover, provisions in the recently passed Protecting Access to Medicare Act of 2014 (H.R. 4302) will soon require health care providers to use said functionality for reimbursement of ordered imaging services. It would be helpful to ordering providers if ONC s related certification criteria at (a)(3) and (a)(10) explicitly require CPOE/CDS to include/enable this functionality (g)(5) - Non-Percentage-Based Measures Report The ACR recommends that the proposed (g)(5) exclude from the non-percentage-based measures report any CMS Meaningful Use (MU) objectives that merely require implemented or enabled functionality. The primary example of this is CMS MU objective for CDS. EPs are required to implement a minimum number of CDS rules/interventions in Stage 1 and Stage 2 MU; however, CMS does not require the implemented/enabled functionality to actually trigger a minimum number of times. Zero triggers could occur if the EP had minimal personal interaction with CEHRT, or if the enabled CDS rules/interventions required sufficiently rare or extreme circumstances to occur before triggering and alerting the user. ONC s proposed certification criterion at (g)(5) would go beyond CMS MU requirements for EPs in a manner that would negatively impact the accuracy of auditing program participants. Using the above CDS example, an auditor could review the non-percentage-based measures report and incorrectly conclude that the EP failed the CDS objective if none of the implemented CDS rules/interventions were triggered during the reporting period. The ACR understands that CMS and ONC are under considerable external pressure to verify participants compliance with the non-percentage-based MU measures. However, MU measures that merely require a given functionality to be implemented cannot be appropriately accounted for under the proposed criterion at (g)(5). To avoid auditing errors, auditor confusion, and the subsequent burden for the EP of follow-up and appeals, only non-percentage-based MU measures that require generation of a positive numerator (for example, the generate one patient list measure) should be included in the report (b)(1) - Transitions of Care The ACR believes that the criterion for transitions of care/referrals should be linked to the CPOE workflow when it comes to radiology/imaging orders, in that the radiology/imaging CPOE process should involve transmission of the Consolidated CDA from the ordering provider to the rendering provider, and that the C-CDA should include the structured reason for the order. Exchanging extensive patient data from the ordering provider to the rendering provider via the C-CDA would be critical for any non-patient-facing specialists, such as certain diagnostic radiologists, particularly if those specialists had no other reasonable method through which to collect the data needed for their own MU compliance Certification Packages of EHR Modules The ACR does not support the concept of certification packages of EHR Modules, particularly not beginning with the 2015 Edition EHR Certification Criteria. The added complexity and risk of 3

4 confusion would outweigh any practical use for EHR Incentive Program participants of EHR Modules being marketed in the proposed Care Coordination and Patient Engagement packages. Certification packages could potentially be helpful if they were geared toward specialty archetypes for example, a radiologist EP package that covers all Base EHR criteria and any other certification criteria most radiologist EPs would likely need to satisfy the CEHRT definition. Packages could be defined through guidance in collaboration with related national specialty societies and specialty HIT vendors. Considerations for 2017 Edition EHR Certification Criteria View/Download/Transmit Criterion and Images The ACR would like to respond to the questions for the 2017 Edition related to imaging and the view/download/transmit certification criterion: 1) Whether images for patients need to be of diagnostic quality; ACR response: While patients do not generally need diagnostic quality images for their own personal use, radiological images should be of diagnostic quality if transmitted to a physician/provider third party. 2) Whether they should be viewable and downloadable; and, 3) Whether cloud-based technology could allow for a link to the image to be made accessible. ACR response: Please see the recent recommendations of the HIT Standards Committee (HITSC)- Clinical Operations Workgroup for a look at standards and methods to enabling image sharing for various use cases ( tiers of need). Given the timing, we understand the HITSC Clinical Operations Workgroup s efforts on imaging standards likely concluded after the 2015 Edition NPRM went through the drafting process (but prior to publication). We therefore encourage ONC staff to revisit that work which was largely supported by the radiology informatics community to inform the future 2017 Edition EHR Certification Criteria rulemaking. 4

5 Non-MU EHR Module Certification Status The ACR does not support the establishment of a new ONC certification pathway for non-mu EHR Modules that merely borrows MU-related certification criteria and removes the automated calculation requirements. Developers of HIT products used by physicians should instead be actively encouraged by ONC to seek certification for any and all applicable criteria so that those products can be appropriately used by participants in the EHR Incentive Program. There is a prevalent misunderstanding within various specialty IT communities that ONC s certification program is reserved for comprehensive EMR products, when really the certification criteria were designed to be functionality-focused, architecturally agnostic, and conducive to modular combination. Unfortunately, certification of many specialized HIT products, such as Radiology Information Systems (RIS), is considerably rarer than it should be. A non-mu EHR Module certification status could potentially compound this problem by creating even more confusion in the specialty HIT industries and end-user communities. The ONC s proposal for this concept does not provide evidence of a practical use, significant market demand, or any other benefit for this certification status that outweighs the risk of additional confusion and missed opportunity. The ACR recognizes that ONC is permitted by statute to establish voluntary certification processes for HIT unrelated to the EHR Incentive Program. If ONC chooses to leverage this authority, the new certification processes should be unrelated to MU in other words, should not duplicate the existing ONC certification criteria and should be implemented via a separate rulemaking or 5

6 guidance. Such a certification status should focus on promoting interoperability and exchange. Most importantly, such a certification status should be reserved for software designed for nonphysician allied health professionals and patients. Developers of HIT solutions designed for physician end-users should instead be proactively encouraged by the agency to certify their products for use in the EHR Incentive Program. HIT Module Recognition The ACR generally supports the concept of improved or alternative certification criteria that better reflect the functionalities and standards needed in specialty HIT solutions. We do not, however, support the creation of HIT Module recognition for certified EHR Modules that are nontraditional EHR software/services unless there was a regulatory necessity for creating this sub-categorization scheme. A unique HIT Module designation could be useful if CMS created alternative MU compliance pathways for certain types of specialist EPs and ONC needed to likewise create different sets of certification criteria for functionalities to support those alternative MU compliance pathways. However, establishing an HIT Module category of certified EHR Module products without also establishing a corresponding set of alternative certification criteria would generate unnecessary complexity. The ONC s stated purpose of this designation i.e., marketing and purchasing clarity would be better handled with education and guidance for industry and consumers of nontraditional EHR technology solutions that have (or should have) obtained EHR Module certification. Conclusion As always, ACR welcomes the opportunity for continued dialog between the radiologist community and ONC on all things related to the EHR Incentive Program and HIT policy in general. Please contact Michael Peters, ACR Director of Legislative and Regulatory Affairs, at / mpeters@acr.org if you have questions or we can be of further assistance. Sincerely, Paul H. Ellenbogen, MD, FACR Chair, Board of Chancellors American College of Radiology Keith J. Dreyer, DO, PhD, FACR Chair, IT and Informatics Committee American College of Radiology 6