EHR and CHIME: A Case Study

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College of Healthcare Information Management Executives, Public Policy Office 4300 Wilson Blvd., Suite 250 · Arlington, VA 22203

Phone: (734) 665-0000 · Fax: (734) 665-4922 · [email protected] · www.cio-chime.org April 28, 2014

Karen DeSalvo, MD

National Coordinator for Health Information Technology

Office of the National Coordinator for Health Information Technology Department of Health and Human Services

Submitted electronically at: http://www.regulations.gov

Re: Voluntary 2015 Edition Electronic Health Record Certification Criteria: Interoperability Updates and Regulatory Improvements

Dear Dr. DeSalvo:

The College of Healthcare Information Management Executives (CHIME) is writing in response to the proposed rule at 45 CFR Part 170, “Voluntary 2015 Edition Electronic Health Record

Certification Criteria; Interoperability Updates and Regulatory Improvements,” published in the February 26, 2014 Federal Register.

CHIME is a professional association representing more than 1,400 chief information officers (CIOs) and other top information technology executives at hospitals and clinics across the nation. CHIME members have frontline experience in implementing the kinds of clinical and business IT systems needed to realize healthcare transformation. Healthcare CIOs share the vision of an e-enabled healthcare system as described by the many efforts underway at the Department of Health and Human Services (HHS).

CHIME appreciates the opportunity to comment on the ONC Notice of Proposed Rulemaking (NPRM) and would like to offer thoughts that we believe have broader implications for hospitals and eligible professionals. They include the following proposed strategies: (1) definitions and changes to “Complete” EHRs; (2) Non-MU EHR Technology Certification proposals; (3)

Certification Packages for EHR Modules; and (4) select 2015 and 2017 Edition Certification Criteria. General Comments

CHIME applauds ONC for the innovative approach outlined in this NPRM to make more incremental changes to Certified EHR Technology (CEHRT) for the benefit of usability, interoperability and standards harmonization across federal agencies. Previously, CHIME has supported ONC’s “Edition” construct and we believe this further defines how ONC envisions an extensible certification policy approach that (1) addresses technological deficiencies in currently certified products, (2) incorporates findings and emerging standards, and (3) identifies areas for

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Phone: (734) 665-0000 · Fax: (734) 665-4922 · [email protected] · www.cio-chime.org

future software development work. While we acknowledge the need to produce periodic, even regular, updates to CEHRT Editions, we question the breadth of this NPRM and the

appropriateness of making a voluntary Edition subject to reference by mandatory programs.

For these and other reasons, CHIME recommends ONC reconsider its rulemaking schedule and scope to find ways to achieve the stated policy goals of this NPRM, without regulation. We recommend ONC move forward with plans to investigate 2017 Edition criteria further and reconsider the more incremental, periodic updates to CEHRT Editions envisioned in this NPRM after the 2017 Edition is deployed for Stage 3. The pace of

regulation in health IT policy has drastically increased in the last five years. This trend is resultant from the nearly $30 billion Medicare and Medicaid EHR Incentive Program, and its associated timelines – not necessarily in response to market failures or deficiencies in healthcare technology. Federal regulations and education materials produced by ONC suggests EHR certification, “provides assurance to purchasers and other users that an EHR system offers the necessary

technological capability, functionality, and security to help them meet MU objectives and measures. Certification also gives providers and patients confidence that the electronic HIT products and systems they use are secure and can work with other systems to share information.” 1_{While we} acknowledge and believe in the underlying purpose of federal certification of EHR technology, we question if the benefits of certification are being realized, or if finalization of this NPRM would make substantial progress towards those benefits.

Alternatively, CHIME recommends ONC severely limit the scope of voluntary 2015 Edition certification criteria to only those it considers urgent “bug fixes” to 2014 Edition CEHRT. Further, CHIME encourages ONC to develop a process to identify such “bug fixes” in the future through an open, transparent process, such as hearings held by the Health IT Standards Committee, which can be regularly convened to provide periodic updates less frequently than this NPRM proposes. The ONC’s Federal Advisory Committees should provide feedback before the

publication of an NPRM to help policymakers understand which standards are working, those that are not, and how best to integrate emerging standards/policy needs into a national certification program referenced by a mandatory reimbursement program.

Should ONC refuse our primary recommendations, we strongly urge ONC to dissociate pieces of this NPRM that are likely to be used by reference in other state/federal programs, unless such references are discussed openly among a transparent group of healthcare stakeholders. We believe one of ONC’s many policy goals associated with this NPRM is to help the federal government harmonize health IT standards, and we support ONC’s efforts to do so. However, we are concerned the voluntary nature of this Edition would become mandatory via reference, without a proper dialogue. For example, we could foresee state governments reference ONC’s “care coordination package” as prerequisite for participation in Medicaid, and while not

1_{U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information} Technology, Certification Programs & Policy: About Certification, Retrieved from http://www.healthit.gov/policy-researchers-implementers/about-certification, accessed April 22, 2014.

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inherently problematic, it complicates the goal of harmonization and would undoubtedly lead to more costs and confusion for providers.

The rapid pace of regulation since 2010 has created a constant cycle of deployment and go-lives across our nation’s hospitals, with several providers foregoing the necessary workflow and change management processes needed to optimize technology for the benefit of care delivery. For vendors, upon which providers have become increasingly dependent, this means implementation queues and multiple – sometimes drastic – technology patches. This paradigm exposes providers to increased costs, strained financial and personnel resources, and potential patient safety issues.

The constraints defined by HITECH should no longer drive ONC’s regulatory activity. Instead, we urge ONC to identify a more limited set of high-impact changes to 2014 Edition CEHRT and plot a course of CEHRT Edition updates, consistent with the needs of patients and their providers. Definitions and changes to “Complete” EHRs

Recommendation: CHIME recommends ONC focus its policy efforts to cultivate a modular approach to EHR development and certification. We believe the Base/Menu construct is appropriate for future Editions of CEHRT, while phasing out the definition for Complete EHR.

CHIME believes providers should have the ability to purchase only those EHR modules they need to satisfy core and menu requirements for Meaningful Use. Separation of EHR modules into a Base EHR that all EHs and EPs must possess, plus Menu EHR modules, would seem to have achieved this goal for the 2014 Edition. As such, CHIME recommends keeping the Base/Menu construct, while phasing out Complete EHR designations. However, we wish to underscore the need to ensure that providers have access to information and education materials in absence of demarking Complete EHRs.

CHIME also supports a CHPL requirement to disclose more information related to the technical /architectural approach /schema /compilation of CEHRT modules.

Non-MU EHR Technology Certification

Recommendation: CHIME supports the creation of a Non-MU certification track for products that do not require the counting functions necessitated by Meaningful Use thresholds. However, we strongly encourage ONC to require developers of Non-MU modules to state its applicability (or not) to MU requirements in marketing or

communication materials.

CHIME only foresees confusion among purchasers who are presented with two versions of the same product without any designation describing it’s applicability to Meaningful Use. It is unclear

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why such disclaimers would not be required by ONC to help purchasers navigate the marketplace for certified EHR products.

Certification Packages for EHR Modules

Recommendation: CHIME questions the need for such packages and does not support the grouping of certification criteria, beyond what ONC has done to differentiate and define Base EHR.

CHIME is concerned this kind of grouping would add more complexity to the purchase and maintenance of CEHRT, not less. ONC’s proposal to discontinue Complete EHRs seems

consistent to improve effectiveness and decrease burden; however, this suggestion seems to produce the opposite effect. We question why ONC would want to create packages for voluntary

certification through regulation if these packages would not fulfill federal program requirements. If the intent is to help Long-Term & Post-Acute care facilities, for example, determine which pieces of technology would enable them to “close the referral loop,” then why not let market forces produce such packages? If the intent is to prevent up-selling to LTPACs by bad actors, ONC should focus on educating other segments of the provider world on what would be technologically appropriate to be meaningful contributors to patients’ medical records?

2015 Edition EHR Certification Criteria “Create” and Patient Data Matching Quality

CHIME has three main recommendations for the patient matching capabilities proposed under the ToC certification criterion:

 CHIME strongly supports the inclusion of the proposed constrained specifications for last name/family name, suffix, date of birth, current address and historical address, phone number, and sex in the voluntary 2015 edition and the 2017 edition certification criteria as standardization of these elements will increase patient matching accuracy. We also

encourage the inclusion of historical address to help providers and hospitals identify patients that have moved locations.

 CHIME suggests a feature that easily moves outdated information to historical categories rather than deleting it when information is updated.

 ONC should leverage existing standards when possible for demographic information.

Developing a consistent strategy to match patients with their correct data has been a top CHIME priority for several years, thus we support the inclusion of proposed certification criteria in the 2015 Edition. Further, we recommend ONC take steps to validate and make mandatory these standards for the 2017 Edition.

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formats for first/given name and middle/second name (or middle initial). Additionally, CHIME supports standardization for data elements that do not change such as place of birth and maiden name. Similar to maiden name, CHIME would also suggest the inclusion of a field for “former name” as many patients change their names for purposes beyond marriage. We believe the inclusion of a few standardized “optional” fields (most importantly place of birth, maiden name, former name, and historical address) will help identify patients based on algorithms that are currently being used in the hospital setting. From a data standpoint, CHIME members feel that these additional fields would not overreach what registration staff can capture during the intake process.

Further, CHIME requests that additional research on the benefits of using additional demographic fields listed in the NPRM for patient matching be completed before those fields are mandatory for certification. These fields include: email address, “Direct address,” mother’s first and maiden name, father’s first and last name, driver’s license number, passport number, or eye color. While adding fields that are “not likely to change” can be helpful for patient matching, adding more fields for the sake of adding more fields may be costly and over burdensome on vendors and registration staff. In terms of using United States Postal Service (USPS) standards for current and historical address, CHIME finds it reasonable for the USPS to make available the use of this standard address format to be used in electronic health records. Consistent with our recommendation that ONC should leverage existing standards when possible, CHIME would support the use of these standards for current and historical address. And to reiterate, CHIME would support the inclusion of a feature that easily moves the primary address to the historical address category rather than deleting the information when the primary address is updated.

ONC has asked for comments on developing open source algorithms for testing purposes or use by EHR developers. CHIME believes an open source algorithm would be helpful for patient matching as it could give developers access to a standard algorithm if they do not want to develop their own, and it could also set a minimum standard for patient matching accuracy. However, CHIME does not recommend a mandatory algorithm. In response to ONC’s query about developing and/or disseminating options and training materials that improve data quality, CHIME suggests that these guides be created on a regional or local level. Communities across the country have populations with unique name patterns and CHIME believes that training guides should reflect regional nuances. Select 2017 Edition Certification Criteria

Duplicate Patient Records

CHIME supports the inclusion of user reports that detail potential duplicate patient records as well as merge and unmerge functions in EHRs in the 2017 edition for Stage 3. Merging and unmerging records has proved to be costly and time-consuming, while increasing the potential for patient safety issues related to health IT. Allergy lists are the biggest concern in the merge/unmerge process, as it could have grave implications for a patient if allergies are missed when medications are administered.

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ONC should require patient safety quality checks around this functionality. If an EHR could take snapshots of each record before and after two records are merged, this could potentially mitigate mistakes during the unmerge process.

We hope this feedback is helpful. CHIME appreciates the opportunity to provide comments and would like to be a resource to ONC and subsequent efforts to improve federal health IT efforts. If there are any questions about CHIME’s comments or more information is needed, please contact Jeffery Smith, Sr. Director of Federal Affairs, at [email protected] or (703) 562-8876. We look forward to a continuing dialogue with your office on this and other important matters.

Sincerely,

Russell P. Branzell, FCHIME, CHCIO

President and CEO CHIME

Randy McCleese, M.B.A., M.S., FCHIME, LCHIME, CHCIO

Chair

CHIME Board of Trustees Vice President of IS and CIO St. Claire Regional Medical Center