1.) Recognize and reward the pathology and laboratory community s informational, operational, and financial contributions toward the MU of EHRs

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1 April 28, 2014 National Coordinator for Health Information Technology Department of Health and Human Services Office of the National Coordinator for Health Information Technology Attention: 2015 Edition EHR Standards and Certification Criteria Proposed Rule Hubert H. Humphrey Building, Suite 729D 200 Independence Avenue, SW Washington, DC Re: Voluntary 2015 Edition Electronic Health Record (EHR) Certification Criteria; Interoperability Updates and Regulatory Improvements (RIN 0991 AB92) I am writing on behalf of the American Society for Clinical Pathology (ASCP) to provide comment on the proposed 2015 Edition EHR Standards and Certification Criteria. The ASCP is a 501(c)(3) nonprofit medical specialty society representing more than 100,000 members. Our members are board certified pathologists, other physicians, clinical scientists, certified medical technologists and technicians, and educators. ASCP is one of our nation s largest medical specialty societies and is the world s largest organization representing the field of laboratory medicine and pathology. As the leading provider of continuing education for pathologists and medical laboratory personnel, ASCP enhances the quality of the profession through comprehensive educational programs, publications, and self-assessment materials. ASCP appreciates ONC s continued efforts to enhance the widespread use of interoperable electronic health record (EHR) technology and health information exchange (HIE) via the ongoing establishment of regulatory standards, certification criteria, and implementation specifications. Though pathologists are unable to participate in the Meaningful Use (MU) program, the pathology community is responsible for inputting more than 50 percent of an EHR s contents which drive nearly 70 percent of all medical decision-making. Accordingly, on behalf of our patient community, ASCP is grateful to ONC for seeking to regulate the timely and reliable order of laboratory test results, their secure transmission to and from EHRs, their accurate and structured incorporation into the patient s health record, and their meaningful use in guiding the most appropriate treatment protocol and/or effectively monitoring patient condition. The Society also appreciates the opportunity to provide feedback to the ONC regarding current barriers, challenges, and opportunities faced by the pathology and laboratory community when seeking to facilitate secure, accurate, meaningful, and efficient exchange of laboratory test results across provider entities. In response to ONC s Proposed Rule, the Society recommends the following to facilitate and accelerate the widespread interoperability of standards-based HIE across providers, settings of care, consumers/patients, and payers: 1) Recognize and reward the pathology and laboratory community s informational, operational, and financial contributions toward the MU of EHRs 2) Increase the frequency of federal rule-making to obtain updated stakeholder feedback, keep pace with advances in industry standards, and extend more flexible/incremental compliance options 3) Transition away from site-neutral certification requirements at the (EHR) system-level to sitespecific certification requirements at the health information technology (HIT) module-level 4) Ensure effective and efficient interoperability through the development of HIE/HIT standards that align and integrate with existing standards for other quality improvement and reporting initiatives 5) Enhance patient and provider access to accurate, robust and meaningful patient health information via geographically boundless, yet secure data portability 1

2 1.) Recognize and reward the pathology and laboratory community s informational, operational, and financial contributions toward the MU of EHRs As previously mentioned above, pathologists are unable to participate in the MU program and are therefore ineligible to receive MU incentive payments. This is because current MU program requirements do not align with pathologists scope of practice, typical interaction with patients, and laboratory-specific information technology used. For example, in lieu of EHRs, pathologists typically utilize laboratory information systems (LISs) and anatomic pathology information systems (APIS) to receive test orders, track test status, report test results, and provide interpretive reports. Once the test results and interpretive reports are generated within the LIS or APIS, they are then typically transmitted by interface to the EHR. Accordingly, a significant barrier to pathologists achievement of MU is that pathologists have little control over whether there is Certified EHR technology (CEHRT) at their practice location because they do not directly input laboratory result data into an EHR. As such, since the definition and use of EHRs in a physician practice is out of the control of the laboratory, pathologists have been granted exemption from having to participate in the MU program which focuses specifically on the implementation and meaningful use of EHRs. Nonetheless, as the MU program advances, the significant informational, operational, and financial contributions of the pathology and laboratory community become both more apparent and more essential. Until recently, pathologists were often expected to fund EHRs for referring clinicians in exchange for referrals. This enabled referring clinicians to qualify for incentive payments that were intended to help offset investment in CEHRT. The Secretary of the Department of Health and Human Services recently estimated that the cost of an EHR per clinician is approximately $54,000 for the first year and $20,610 for subsequent years. Worse yet, these prices do not include the cost of each EHR interface, estimated at roughly $5,000 each. For laboratories providing testing to multiple clinician practice settings and diverse EHRs, the cumulative cost of LIS-EHR interfaces can be substantial. All the while, pathologists are not only incurring these real costs, they are also incurring roughly $40,000 in opportunity cost due to their inability to participate in the MU program through no fault of their own. Moreover, while ASCP was extremely pleased that EHR gifting was deemed a violation of the Stark and Anti-kickback laws in December, a more recent advisory opinion posted by the Office of the Inspector General in April clarifies that laboratories are still permitted to offset the cost of EHR interfaces for referring clinicians. Accordingly, while laboratories have been prohibited from paying compensation (i.e. donating an EHR) to the referring clinician in exchange for referrals, they are still permitted to relieve clinicians from financial obligations and are therefore absorbing the vendor s interface transmission fees on behalf of the referring clinician in exchange for status as the clinician s in-network laboratory. This designation of preferential laboratories actually limits interoperability to in-office and/or in-network laboratories supported by a donor-specific interface. Moreover, even though EHR interfaces are required to be interoperable, the donor-specific interface functions only if specimens are referred to the donor s laboratory, rendering the patient information inaccessible to other health care providers within a patient s continuum of care. Hence, this sort of donor lock is contradictory to ONC s belief that the EHR gifting safe harbor will actually facilitate interoperability. ASCP requests that ONC work within its authority to close this interface funding loophole so that the creation of in-network laboratories will no longer inhibit robust HIE interoperability across all settings of care based on patient, not provider, preference. Similarly, ASCP requests that ONC work with the Center for Medicare and Medicaid Services (CMS) and Congress to eliminate anatomic pathology services from the in-office ancillary services (IOAS) exception to the Stark law as soon as possible. Anatomic pathology services are inappropriately included under the IOAS exception based on the false assumption that they can be provided, with results read, during the clinician office visit. As such, the inappropriate inclusion of these services under the IOAS exception wrongfully affords the clinician the ability to self-refer for these services. Since the referring clinician then has a financial stake in the provision of referral-based anatomic pathology services, this 2

3 results in dramatic overutilization of these services which increases costs for Medicare beneficiaries and taxpayers while potentially harming patients by exposing them to unnecessary invasive tests. Moreover, the clinician s ability to self-refer for anatomic pathology services, inhibits the development of interoperable HIE outside of the clinician s virtual office by limiting system interface interoperability solely to financially affiliated entities. Finally, CMS and ONC s inability to include pathologists in the MU program fails to acknowledge that pathologists were perhaps the first specialty type provider to electronically record and use patient information. Accordingly, the pathology and laboratory community has contributed significantly to the data and operations underlying the meaningful use of EHRs since even before the MU program s onset. Below are some examples of a pathologist s/laboratory s uncompensated, yet essential, responsibilities in support of the MU program: Populate summary of care information in a standardized format to provide a more comprehensive view of patient health throughout transitions of care across multiple (un)affiliated provider entities Securely and accurately integrate laboratory test result information into EHRs in a compatible, meaningful, and directive format; Validate secure and accurate transmission and receipt Generate clinical summaries and patient-specific education materials in order to empower patients to better manage their own health and enable them to easily share their information with relevant third parties Generate standardized clinical decision support interventions to guide provider decision-making and direct the most appropriate, affordable, and effective treatment decisions Accordingly, given the above examples among many others, the pathologists specialty-specific hardship exemption is beginning to more accurately translate to exemption from receiving an incentive payment resulting from significant program contributions rather than exemption from a payment adjustment resulting from failure to contribute to the MU program s goals and objectives. Moreover, ASCP anticipates that the role of the pathologist/laboratory will only continue to expand as the role of laboratory test results is increasingly leveraged and included in MU program requirements. As such, ASCP continues to call upon ONC and CMS to recognize the important role of the pathologist in securing and financing, the accurate, timely, comprehensive, meaningful, and directive incorporation of diagnostic information into a patient s EHR. 2.) Increase the frequency of federal rule-making to obtain updated stakeholder feedback, keep pace with advances in industry standards, and extend more flexible/incremental compliance options ASCP supports ONC s transition to more frequent communication with stakeholders, but urges ONC to extend flexibility to stakeholders regarding compliance with more frequent regulatory updates. More frequent rule-making could be used as an instrument to provide providers and vendors with greater and earlier visibility into ONC s regulatory direction before compliance is required and to allow more time for public input on policies proposed. In aligning its regulatory process with the ever-evolving industry of HIT innovations, ONC would be able to communicate and solicit comment on newer industry standards as they become available, spur innovation, open new market opportunities, and provide more choices. As such, ASCP urges ONC to leverage this more frequent communication to solicit feedback on the clinical utility and feasibility of new industry standards. More frequent insight into providers current HIT capabilities would allow ONC to communicate more realistic compliance dates in advance. Conversely, more frequent rule-making should not be used as a mechanism for rapid imposition of updated regulatory requirements. 3

4 Moreover, as a demonstration of its understanding that provider groups vary in their selected vendors HIT capabilities, ASCP supports ONC s proposal to offer and reward the voluntary certification of HIT modules prior to the mandatory compliance date. Similarly, the Society supports ONC s intentions to communicate which voluntary HIT updates are eligible for gap certification if their related requirements remain unchanged under the next mandatory certification criteria edition. This will ensure that providers advancing HIE and interoperability at faster paces than others will continue to lead the industry rather than halt advancement to align with slowed program implementation and/or less advanced provider entities. 3.) Transition away from site-neutral certification requirements at the (EHR) system-level to sitespecific certification requirements at the health information technology (HIT) module-level ASCP is increasingly aware of emerging gaps between ONC s ideal certification criteria and that which is currently feasible for all provider specialty types across the vast number of possible care settings. The Society believes that these gaps are a result of ONC s initial one-size-fits-all approach to the certification and standardization of EHR systems. Accordingly, just as it is inappropriate for different specialty-type providers to offer a one-size-fits all treatment plan across all care settings, it is equally inappropriate for ONC to offer a one-size-fits-all solution for advancing the HIE of specialty-specific patient health information across all care settings. ASCP strongly encourages ONC to recognize and account for the varying rates of HIE advancement, the diverse selection of (non-ehr) information systems, and the unique needs of providers across all possible health care settings when establishing HIT and HIE certification and interoperability standards. As such, ASCP is pleased that ONC is considering broadening the scope of the MU program to acknowledge and potentially regulate the vast array of non-ehr HIT tools that serve as the data input source for many specialty providers. The incorporation of patient information into EHRs via these tools is essential for the development of a comprehensive picture of patient health and the recognition of these tools via the Meaningful Use program is crucial to the program s ability to capture a comprehensive picture of data input and output throughout a patient s entire care continuum. ASCP strongly supports ONC s movement away from complete EHR certification and toward the certification of EHR and non-ehr HIT modules. Through the strategic establishment of uniform yet modular standards, ONC has the opportunity to regulate the meaningful use of new and old HIT products while providing the flexibility to (specialty) providers to select and implement the (non-)ehr (HIT) modules most applicable and beneficial to the needs of their specific practice. The modular certification of EHR/HIT standards means that required updates will affect only the relevant component of the standard, and will not require changes to the entire standard. Accordingly, if one EHR/HIT component is advancing in the market at a faster rate than another component, ONC can update its specific standard at a more granular level in order to reflect this variance in technological advancement. As such, modular certification not only facilitates implementation flexibility, but also enhances the efficiency behind EHR implementation and HIE advancement. In example, the modularization of EHRs/HIT enables providers to target investments at the EHR/HIT features and functions necessary to fulfilling the needs of their specific practice. Moreover, it allows vendors to swap out or replace EHR/HIT components, as needed, as module-level standards continue to evolve at varying paces. Lastly, this level of granularity in the development and implementation of EHRs/HIT aligns with the level of granularity in the regulation of EHRs/HIT. Accordingly, in decoupling two different EHR/HIT functions within a single criterion, ONC can assure that providers will not have to certify an EHR/HIT function that supports a measure for which they qualify for an exemption just because it is coupled with a separate HER/HIT function that is applicable to their practice. 4

5 In demonstration of ASCP s support for ONC s proposed movement toward the modular certification of EHR features and functions, the Society supports the following provisions within this Proposed Rule: CPOE: The division of the computerized provider order entry certification criterion into three separate certification criteria, with each criterion focused on one of the three order types. CDS: The distinguishing of laboratory values/results data from vital signs and medications data when assessing and requiring info-button capabilities in support of clinical decision support; Note: ASCP still strongly advocates for a more feasible approach to pulling laboratory data in the development of a CDS Knowledge Artifact standard ToC: The decoupling of transport and content within the single Transitions of Care certification criterion recognizes that these two separate capabilities may require unique HIT support and may be adequately provided by two separate systems. In establishing separate certification and testing for these functions, ONC is enabling more transport-specific services to be certified and affording providers a broader selection of electronic health information exchange services. 4.) Ensure effective and efficient interoperability through the development of HIE/HIT standards that align and integrate with existing standards for other quality improvement and reporting initiatives As HIE and data interoperability evolves via the development of highly distributed and diverse HIT modules, it is essential that ONC readily establish standards to assure the secure transport, format compatibility, accurate integration, and meaningful use of patient information within and across these separate products and services. As such, ONC may want to consider the following options for developing and implementing HIT/HIE standards: Establish certification requirements for patient health records to facilitate standardization and cross-provider utilization Enable secure and reliable identification verification processes to confirm the identity of the patient/third party representative that is requesting patient health information as well as the appropriate patient-level health record Require compliance certification of EHRs and the HIE systems to reduce variability of system exchange standards and the cost of implementation Require adherence to HIE infrastructure standardization to enable bidirectional information exchange and eliminate the need for multiple interfaces Foster open source software development that includes ONC-approved and tested standards Align health care administration and clinical standards across HHS programs and initiatives in support of standards-based HIE interoperability Additionally, in allowing for the certification of both EHR and non-ehr HIT modules, ONC would not only be enhancing the flexibility behind participating in the MU program, but also opening doors for the use of HIT modules in support of other programs and initiatives. Accordingly, ASCP supports ONC s proposal to certify (non-)mu EHR and HIT modules in support of other quality improvement and reporting initiatives. The Society values ONC s role in regulating HIT modules to support the specific requirements of the MU program and believes its regulatory authority could be equally valuable in assuring HIT modules support the requirements and align with the standards of other equally valuable quality promoting initiatives. Accordingly, ASCP supports the standardization of data elements via alignment with electronic Clinical Quality Measures (ecqms) and regulatory requirements aimed at improving the quality of patient care. 5

6 CLIA Requirements: Given the rapid adoption and advancement of HIT across the health care sector, ASCP believes that the alignment of EHR and, more broadly, HIT functionality with Clinical Laboratory Improvement Amendments (CLIA) regulatory requirements is becoming increasingly essential. More importantly, it has the ability to yield a positive dual impact on patient care, as it both enhances interoperability and assures compliance with CLIA regulations which are intended to promote quality and efficiency both within and beyond the laboratory. Accordingly, ASCP supports the inclusion of CLIA-specific requirements in the following standards: Laboratory orders: Current CLIA regulations governing the accurate communication and receipt of test orders and results require that each laboratory establish, and support via written policies and procedures, an ongoing mechanism to monitor, assess, and, when indicated, correct identified problems. Accordingly, ASCP supports ONC s proposal to update related certification criterion to enable the HIT support necessary for the fulfillment of these CLIA requirements and assure the accurate, reliable, and timely ordering and reporting of laboratory test results. Transmission of electronic laboratory tests and values/results to ambulatory providers: ASCP supports ONC s proposal to enhance certification requirements for this EHR functionality so as to better align with CLIA requirements and subsequently improve the consistency in how laboratory tests and values/results are sent, received, and displayed. Electronic incorporation of lab results: ASCP supports ONC s proposal to enhance certification requirements for this EHR functionality so as to better align with CLIA requirements and subsequently improve the consistency in how laboratory tests and values/results are displayed and better comply with related CLIA requirements. While ASCP promotes the continued alignment of EHR certification criteria with CLIA regulatory requirements, we urge ONC to work with vendors to assure the widespread availability of these enhanced EHR capabilities prior to imposing updated mandatory certification criteria on providers. ASCP encourages further integration of Logical Observation Identifiers Names and Codes (LOINC) into every possible program as the best method to increase the interoperability and electronic exchange of laboratory test results. This could be achieved via the mapping of other standards to LOINC and/or the revision of CLIA standards to require laboratories to send results using LOINC. Accordingly, the ONC Laboratory Reporting Implementation (LRI) guide, as mandated by the 2014 Standards and Certification (S&C) Final Rule, requires most laboratories to incorporate updates/upgrades to their LISs to accommodate LOINC codes but is not directly reimbursed via the MU program. As such, it is not just the interfaces themselves that will require funding, but there is also a need for additional monies and education for laboratories and providers/ehr users on LOINC and SNOMED CT encoding and mapping of laboratory test results. Nonetheless, there is efficiency and cost-savings to be gained in this process if ONC supports the converging on one standard for multiple, related, and integrated HIT functions. For example, it would make sense to require laboratories to incorporate updates/upgrades to their LISs to accommodate LOINC codes for the ONC Laboratory Orders Implementation (LOI) guide, in addition to the LRI guide. However, integrating LOINC into every possible program does not automatically assure standardized use of clinical vocabularies. Rather, due to the variability of coding and site-specific licensure restrictions, LOINC coding does not adhere to a standard definition. Hence, ASCP requests that ONC work with laboratory organizations to provide guidance about terminology mapping best practices to ensure that laboratory test results 6

7 are mapped to codes that are as specific as possible to provide downstream users as much information as possible about laboratory tests and their values. In summary, ASCP anticipates that the electronic enabling of many of the capabilities required for CLIA compliance, such as the laboratory s requirement to test each LIS-EHR interface, will be very resource and time-intensive. Accordingly, ASCP urges ONC to consider the administration of supporting guidance and/or financial assistance to aid laboratories in the implementation of these enhanced HIT capabilities. Physician Quality Reporting System (PQRS) Despite pathologists inability to participate in the MU program, ASCP is hopeful that the development of Qualified Clinical Data Registries (QCDRs) will enable more pathologists to successfully participate in the Physician Quality Reporting System (PQRS). As CMS works to align quality reporting requirements across the two programs, via ecqm reporting, it is essential that ONC also work to align the quality reporting mechanisms via the establishment of standardized interoperability and certification requirements across the two programs. As such, it is currently near impossible to certify a QCDR to meet the requirements for an EHR module given their clearly different intended purposes. ASCP encourages ONC to extend the option for HIT module certification to QCDRs under the PQRS program and standardize a format that fulfills certification requirements for both the MU program and PQRS. Along those lines, as CMS provides more flexible participation options and the development of specialty-specific measures within the PQRS program, it should clearly communicate how this will affect specialty type providers that qualify for a hardship exemption under the MU program. If the goal of the HHS is to align program requirements and HIE certification standards across all quality reporting programs, it is important for CMS and ONC to work together to enhance participation flexibility at the same rate across programs. Conversely, right now the PQRS program is adapting to accommodate all specialty providers via the introduction of a much more comprehensive and robust HIE tool than EHRs. Meanwhile, the MU program is not progressing at a parallel rate toward this level of participation flexibility and HIE functionality. Value-based Payment Modifier Program and Advanced Payment Models It is essential that CMS and ONC work together to integrate HIE certification requirements and interoperability standards into payment and delivery system reforms. Such integration is crucial to the necessary transformation of the fragmented fee-for-service payment and delivery model into an advanced model that is both patient-centered and value-driven. Absent this effort, providers and vendors will not yet have a business imperative to electronically share person-level health information across provider entities and settings of care. However, ASCP cautions that payment and delivery models should not require advanced interoperability capabilities until they are made widely available to all provider type specialties across all care settings. It is especially important that requirements reflect market availability as CMS and ONC work to transition the Value-based Payment Modifier program from a system of incentives, to payment adjustments, and eventually systemic requirements for conditions of participation. In the interim, ASCP encourages ONC to offer voluntary opportunities to adhere to incremental integration of HIE certification and interoperability standards into payment and delivery models when made possible. ONC can also offer opportunities to integrate HIE certification and interoperability standards into the current FFS reimbursement model via the establishment of additional codes to reimburse for care coordination and/or interface validation. 5.) Enhance patient and provider access to accurate, robust and meaningful patient health information via geographically boundless, yet secure data portability 7

8 The goal of increasing the robust exchange of patient health information should only be sought if patient safety can also be assured. Currently, CLIA does not prescribe the means by which a laboratory would test the accuracy and timeliness of their test report transmissions via LIS-EHR interfaces. Laboratories utilize varying test methods/devices for this testing, including manual and automated methodologies/devices. ASCP urges CMS to acknowledge the resource- and time-intensive laboratory validation of LIS-EHR interfaces and recognize the laboratories limitations in assuring the accuracy and completeness of data transmission on the receiving end. ASCP requests that ONC provide funding, resources, training, and standardization of this process through the HIT certification program so that it complies with existing CLIA requirements. Patient Access to Test Results In February CMS published a Final Rule in the Federal Register that granted patients direct access to their laboratory test results by requiring that all HIPAA-covered laboratories provide this information directly, and ideally electronically, upon patient request. ASCP is a major proponent of empowering patients to be more actively involved in the management of their own health and therefore supports this new law. However, upon release of this final rule, the Society cautioned our members that laboratory test results provided without context could actually harm patients. Accordingly, ASCP released guidance to our members, encouraging them to direct their patients to consult their referring clinicians regarding the meaning of their laboratory results upon receipt. Further, we explained to our members that, while this rule does not require it, laboratories will have the option to provide their patients with supplementary educational materials regarding the meaning of their test results. In response to this recently finalized regulation and the enhanced laboratory obligations that go along with it, ASCP supports ONC s eventual intention to use laboratory result data to generate patient-specific education materials. However, while ASCP is appreciative that ONC has recognized that the info-button standard cannot support the level of data specificity needed to electronically identify patient-specific education resources based on laboratory values/results, we stress the potential value-add of this function now that patients may receive their laboratory test results directly. We encourage ONC to work with vendors to ensure that this capability is developed and readily available in the near-term. Accordingly, absent patient consultation with their referring clinician, laboratory-generated and provided education materials may be the only guidance available to patients regarding the meaning of their laboratory test results. Laboratory Access to Patient Health Information The bidirectional flow of patient health information to and from the laboratory is essential to ensuring quality care across the patient s entire care continuum. Just as it is important to validate that clinicians have accurately and completely received laboratory report data, it is equally important for laboratories to have access to the full scope of patient health information in order to assure accurate and meaningful laboratory testing that is reflective of the full scope of the patient s health and capable of effectively guiding treatment protocols. Accordingly, ASCP supports the development of a provider directory that ensures all relevant providers including pathologists have the ability at any point in the decision-making process to access and edit the information on the patient s health status, the health care plan, and results. Such information helps to avoid medical errors, unnecessary duplication of services, and underuse of appropriate services. As such, ONC should release guidance on the interpretation of the Minimum Necessary Rule in the HIPAA Privacy Rule to assure that it does not restrict pathologists access to important patient-level clinical information. 8

9 Additional options for ONC to expand the availability of patient health information across patients, providers, and even payers while ensuring the privacy and security underlying its transport include: The development of an HIE certification program to ensure improved security of patient data Patient-level data matching capabilities to guide targeted and secure extraction of patientlevel data across provider entities The development of standards and technology to facilitate electronically obtaining patient consent to disclose patient health information The credentialing of patients to support data validation processes The development of HIT and HIE capabilities to support data provenance The development of HIT and HIE infrastructure to support patient and provider data monitoring and editing capabilities While ASCP will continue to offer guidance to the pathology and laboratory community regarding the provision of informational, operational, and financial support for the achievement of MU of EHRs, the Society encourages ONC to work with CMS and Congress to integrate quality initiative requirements to jointly recognize, regulate, and reward these efforts. Absent financial and technical assistance, laboratories may not be able to sustain the costs nor adhere to the underlying HIE standards necessary for the development of a truly interoperable HIE system. Failure to capture laboratory test result data and leverage the role of the pathology and laboratory community threatens not just the achievement of an interoperable HIE system but also the secure, meaningful, and robust information sharing necessary across patients, providers, and payers to ensure patient-centered, value-based health care delivery and payment. ASCP appreciates the opportunity to present these comments. If we can be of further assistance, please do not hesitate to contact me, Kaitlin Cooke, at (202) Sincerely, Kaitlin Cooke, MPP Senior Manager, Advocacy & Public Policy, ASCP 9