McKesson Corporation Ann Richardson Berkey
One Post Street Senior Vice President, Public Affairs San Francisco, CA 94104-5296
McKesson comments on ONC Health IT: Standards, Implementation
May 7, 2012
Farzad Mostashari, M.D., ScM. Director
Office of the National Coordinator for Health Information Technology Attention: HITECH Initial Set Interim Final Rule
Hubert H. Humphrey Building, Suite 729D 200 Independence Avenue, S.W.
Washington, DC 20201
Re: Health Information Technology: Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology, 2014 Edition; Revisions to the Permanent Certification Program for Health Information Technology
Dear Dr. Mostashari:
On behalf of McKesson Corporation (“McKesson”), I am pleased to submit comments to the Office of the National Coordinator for Health IT (ONC) regarding the proposed rule for Health Information
Technology: Proposed 2014 Edition EHR Certification Criteria.
For 179 years, McKesson has led the industry in the delivery of medicines and healthcare products to drug stores. Today, a Fortune 15 corporation, we deliver vital medicines, medical supplies, care management services, automation, and health information technology solutions that touch the lives of over 100 million patients in healthcare settings that include more than 25,000 retail pharmacies, 5,000 hospitals, 200,000 physician practices, and over 10,000 extended care facilities and 700 home care agencies. McKesson delivers medicines to the entire Department of Veterans Affairs system, as well as to a significant number of Department of Defense and other government facilities. McKesson is also one of the nation’s largest distributors of biotechnology and specialty pharmaceutical products and services for providers and patients.
Our perspective on the proposed rule is based on our extensive experience with health IT and the improvements in quality, safety and efficiency that can be realized by hospitals, health systems,
physicians and pharmacies. We are one of the leaders in providing certified electronic health records. As a member of the Electronic Health Record Association (EHRA), we endorse the comments submitted by this organization.
Noted below are our recommendations on the proposed changes to certification, quality measures, certification requirements and transparency. Additional detailed recommendations requested by ONC are provided in the attached document.
Revised Certification Framework
McKesson applauds the proposed change to eliminate the requirement that providers must possess certified electronic health record technology (CEHRT) that has been tested and certified to all applicable certification criteria adopted for the setting (ambulatory or inpatient) for which it was designed. We appreciate ONC’s response to the comments received from the vendor and provider communities regarding the challenges posed by the need to possess a Complete EHR.
We also support the proposal to eliminate the requirements to test for security and privacy for Module EHRs.
Base EHR Certification
McKesson supports the concept of ‘Base EHR’ as a fundamental part of a provider’s CEHRT. We recommend that vendors be given the option to certify as a Base EHR. Additionally, we believe that ONC Accredited Certification Bodies (ACBs) should indicate on the Certified Health IT Products List (CHPL) the Base status of specific CEHRT. We also agree that the proposed ‘Base EHR’ should most appropriately include the security and privacy capabilities for the CEHRT for EPs, EHs and CAHs. In addition, ONC’s proposal that vendors certify the capabilities for “view, download and transmit” as part of the Base EHR certification far exceeds the fundamental capabilities of current EHR technology. Therefore, we recommend that “view, download and transmit” functions be removed from the Base EHR certification and, instead, modularized to support integrated patient engagement capabilities. In
particular, we recommend that certification for this function be explicitly modular, and that ONC work with industry to develop standards that would allow patients to choose their desired patient engagement system.
Timeframe for Implementation
McKesson is committed to the success of the Meaningful Use program. However, successful program implementation requires a clear and realistic timeline. Based on this premise, we do not agree with the ONC proposal requiring use of the 2014 Edition of the CEHRT for providers currently in Stage 1. Providers in Stage 1 during 2014 should be able to use 2011 Edition CEHRT at their discretion, including the 2011 Edition CQMs, but with updated specifications that are available for FY/CY 2014.
Only those providers interested in Meaningful Use Stage 2 in FY/CY 2014 should be required to have a certified 2014 Edition EHR. This delineation would reduce the burden on providers that may be just beginning Meaningful Use Stage 1 and allow them to focus on their workflow changes, system adoption and clinical transformation to achieve Stage 1 objectives.
In our corresponding comments to CMS about Meaningful Use Stage 2, we recommend that Meaningful Use Stage 1 objectives be retained as defined in the final rule, to encourage the use of health IT for information exchange and quality improvement at the point of care.
Incorporation of Quality Measurement in EHRs
The Meaningful Use Stage 1 program called for the rapid development of standards, specifications and processes for electronic clinical quality measures (eMeasures) in order to meet regulatory timelines. As with many new initiatives, these initial guidelines and processes contained features that inadvertently resulted in inefficiencies and inaccuracies. As we have experienced with Stage 1, time pressures can lead to substantial challenges and data integrity issues for eMeasure specifications. We consistently hear about the challenges that providers have experienced with the “hard-coding” of quality measure data elements into the EHR by vendors.
We are encouraged by ONC’s stated intention to provide a testing mechanism to verify the accuracy of measure calculations. Given the immaturity of eMeasurement specifications and the lack of robust implementation guidelines, verifying measures for Stage 1 has presented many challenges. We urge ONC to refer to the HIMSS eMeasures comments submitted to HHS in January 2012, which recommends that both controlled testing and field testing of the eMeasure specification should be part of the measure development and endorsement process. Controlled testing of the eMeasure specification should assure the feasibility, validity, and accuracy of each eMeasure when implemented in an EHR.
For example, during the development of the Measure and the associated eMeasure specification for use in an EHR, an assessment and validation is required to ensure that required data elements can be efficiently and accurately gathered in the healthcare provider workflow. If possible, data elements that are already collected and stored in the EHR in the natural course of the care process should be used. The assessment should also include the identification of any new data elements introduced by the eMeasure specification, as they would require the creation of new standard data types or formats which must be deployed and adopted by providers prior to use in measurement.
An additional challenge results from the lack of generally recognized and/or widely adopted standards for quality measure capture, export, incorporation and calculation. In the proposed rule, ONC asks
specifically about the readiness of the Quality Data Model (QDM) and the Quality Reporting Document Architecture (QRDA) category 1 or 2. McKesson believes that the QDM remains immature; therefore, we recommend an assessment of the QDM standard and its applicability to data capture and workflow requirements in an EHR. We support the QDM and its eventual adoption, but note that measure
developers engaged in Stage 2 specification development are actively wrestling with, and recommending changes to, the QDM, HQMF, and the Measure Authoring Tool (MAT). With active standards
development underway and balloting yet to occur, we do not believe the standard is ready to be used in certification testing in the proposed time period.
In addition, McKesson endorses the framework for aligned performance measurement. We strongly support alignment across federal programs and, more broadly, with the private sector by the use of the same or harmonized measures. We recommend further alignment of e Measures, including the identification of misalignments. For example, we support the use of common EHR data elements to address similar clinical concepts, along with the development of a library of standardized, endorsed “value sets” to be used by measure developers when creating/retooling endorsed measures. We offer some examples in our detailed comments in the attachment.
Finally, McKesson urges ONC and CMS to reconsider the proposed requirement that providers in Meaningful Use Stage 1 must meet all of the latest clinical quality measures defined for the 2014 version of CEHRT at FY/CY 2014. This requirement imposes a significantly greater burden on providers seeking to achieve Meaningful Use Stage 1 in CY/FY 2014 than on early adopters. Public testimony from
providers has consistently indicated that approximately 75% of the effort expended in reaching Stage 1 is associated with clinical quality measurement. This additional requirement will double the quality measures for EPs and result in a 60% increase in effort for the more complex EH/CAH measures in a much tighter implementation window.
Specifications for Certification Requirements Patient Safety Events
McKesson supports provider reporting of patient safety events, including those associated with health IT. Although it is technically reasonable to include a reporting tool or feature in most EHRs, there are a number of unresolved technical and policy issues associated with reporting EHR-collected data that make this feature problematic.
The AHRQ common formats that currently exist were not designed for reporting specific to an EHR. If these formats are eventually utilized, a collaborative effort to refine them should be undertaken.
Moreover, patient safety events are often manifested downstream from the initial care delivery point, such as a physician-generated order that could result in a patient safety event at a later point in time, when the order is actually carried out by the hospital staff. The EHR would be unable to capture this sequence of activities that could lead to an adverse event. Hospitals also generally have a separate risk management process for addressing patient safety issues which includes the documentation and reporting of such events. Requiring this reporting as part of EHR technology would disrupt hospital processes and pose many workflow challenges.
In summary, we do not believe that ONC should adopt such a certification criterion until a process for evaluating and reporting patient safety events is developed and tested.
Quality Systems
With regard to quality systems, we are concerned that ONC did not release a draft of its QMS document at the time that the proposed rule was issued. This document should be subjected to extensive industry and expert review and comments before it is finalized and released for use. If there is not sufficient time for such review, this proposed criterion should not be included.
Usability Reporting
HIPAA Accounting of Disclosures Rule
We do not believe that the certification element related to the HIPAA Accounting Rule should be changed from optional to mandatory or that any other changes should be made to the certification criterion. The optional category is appropriate now because the HIPAA Accounting Rule has not been finalized.
Certification Criteria that Exceed the Meaningful Use Objective
McKesson fully supports the ONC Health IT Standards Committee (HITSC) statement that it would not impose criteria for which there is not a generally recognized and/or widely adopted standard. Prior to the adoption of new objectives and standards, we ask ONC to consider the maturity of both the standards specifications themselves, as well as any terminology requirements referenced by those standards. Some standards may need to be enhanced or developed in their entirety.
Other certification criteria and/or meaningful use objectives may need to be deferred until supporting standards are established and adopted within the industry. Specifically, we recommend that the following be deferred:
Incorporation of discrete data related to the “Summary of Care”; currently, these lack widely adopted standards and the IHE specification that supports their incorporation is still in trial use. The requirement for the use of the “Infobutton” to support clinical decision support, which is not
currently used widely in EHRs.
The certification criteria “Clinical Information Reconciliation”, which far exceeds the associated CMS objective for Medication Reconciliation and is highly prescriptive in design.
The proposed certification criteria for the “transmission of electronic laboratory tests and values/results” to ambulatory providers, which have no corresponding CMS objectives. “Cancer” and “Other Registries” reporting, for which there is no one widely adopted or uniform
standard established to date.
“Family Health History”, “Care Plan” and “Care Team Member”, which are all new objectives with no current standard.
Please refer to the detailed comments for each requirement in the attached template.
We recommend that certification criteria be specific for Stage 2 and provide a long-term progression plan for providers and vendors now and through Meaningful Use Stage 3. Clear delineation of the certification requirements for each stage is critical to enable vendors to enhance their systems to meet specified future criteria. We also suggest that overly prescriptive specifications for criteria, such as “Clinical Information Reconciliation”, be avoided so as to allow for flexibility and innovation.
Transparency of Certification Testing and EHR Pricing Testing
We do not believe ONC should post certification testing results. Inclusion of testing data would not add value to the providers’ CEHRT selection process, as the certification process and most testing results are pass or fail. Providers simply need the testing result, which is available on the ONC’s CHPL.
Pricing
ONC proposes to require EHR technology developers to disclose only the full cost of a certified Complete EHR or certified EHR Module. It would be difficult to compare what is and is not included in the ‘full cost.” Certain sales may also include multiple components of complex software and other technology which would render this cost data misleading. An EHR technology developer may identify a specific system as CEHRT, although we are actually selling a complex mix of software and services to meet specific providers’ needs. For these reasons, we recommend the elimination of this proposal and encourage ONC to allow the marketplace to ensure competitive pricing.
Conclusion
McKesson appreciates the opportunity to provide comments to ONC and share our perspective on the proposed health IT standards, specifications and certification criteria for electronic health record technology, 2014 edition.
In order to successfully implement the 2014 edition and the Permanent Certification Program for Health IT, we recommend that the following be incorporated into the final rule:
Require only those providers seeking to achieve stage 2 in FY/CY 2014 to have a certified 2014 Edition EHR;
Designate “Base EHRs” as distinct certification options, aligned with the individual provider’s requirements;
Continue to address the challenges noted with electronic clinical quality measurement, including controlled and field testing of measure specifications;
Encourage greater recognition and adoption of standards for quality measure capture, export, incorporation and calculation;
Defer prescriptive testing and reporting for safety-enhanced design, quality systems and patient safety events until more extensive industry and expert review has occurred;
Eliminate any proposed change to the certification element related to the HIPAA Accounting Rule;
Align certification requirements with CMS defined Meaningful Use objective and requirements; and
Eliminate public posting of certification testing results or EHR pricing information as part of this program.
We hope these recommendations provide constructive insights as a final rule is determined. Should you have questions or need further information, please contact me at (415) 983-8494 or
Sincerely,
Ann Richardson Berkey
