All official NCVHS documents including meeting transcripts are posted on the NCVHS Website (http://www.ncvhs.hhs.gov/lastmntr.htm).
National Center for Health Statistics
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The National Committee on Vital and Health Statistics Subcommittee on Standards convened a roundtable discussion on November 15, 2012. The meeting was open to the public and was broadcast live on the internet. A link to the live broadcast is available on the NCVHS homepage.
Present:
Committee Members
Walter G. Suarez, M.D., M.P.H., Co-Chair
W.Ob Soonthornsima, Co-Chair
Justine M. Carr, M.D.
Raj Chanderraj, M.D., F.A.C.C.
William J. Scanlon, Ph.D.
Full Committee Members Present
Llewellyn J. Cornelius. Ph.D.
Larry A. Green, M.D., Full Committee Chair
Bruce B. Cohen, Ph.D.
Linda L. Kloss, M.A.
Vickie M. Mays, Ph.D., M.S.P.H. (phone)
Sallie Milam, J.D., CIPP, CIPP/G
Staff and Liaisons
Suzie Burke-Bebee, DNP, MSIS, MS, RN, ASPE
J. Michael Fitzmaurice, Ph.D., AHRQ
Marjorie Greenberg, NCHS/CDC, Executive Secretary
Katherine Jones, CDC/NCVHS staff
James Scanlon, ASPE
Jim Sorace, M.D., ASPE
Marietta Squire, NCHS
Michelle Williamson, R.N., MSIS, CPHIT,NCHS
Absent:
Lorraine T. Doo, M.P.H., Lead Staff
Roundtable Participants
Roxanne Andrews, Ph.D., AHRQ (phone)
Georges Arges, M.D., AHA
Clarice Brown, NCHS
Lawrence Casalino, M.D., Ph.D., Robert Wood Foundation (phone)
Alan Conrad, M.D., Cadillac Family Physicians
Diane Conrad, D.N.P., R.N.,Cadillac Family Physicians
Frank Coyne, BCBSA
John Daniels, HIMSS
Laurie Darst, WEDI
Anne Elixhauser, AHRQ
Doug Fridsma, M.D., Office of the National Coordinator for HIT
Nick Gettas, M.D., CIGNA/Total Health & Network Organization
Karen Hudgins, VA
Chuck Jaffe, M.D., HL7
Charles Kennedy, M.D., Aetna/Accountable Care Solutions
Rosemary Kennedy, R.N., Ph.D., NQF
John Klimek,R.Ph., NCPDP
Alice Leiter, CDT
Deborah Meisner, Emdeon
Judy Murphy, R.N., FACMI, ONC
John Quinn, M.D., HL7
Dan Rode, AHIMA
IyadSabbagh, M.D., Beacon Eastern Maine Health System
Cathy Sheppard, X12
Jim St. Clair, HIMSS
Christine Stahlecker, CMS
Robert Tennant, M.A., MGMA
Robin Thomashauer, CAQH
Margaret Weiker, X12
Kitt Winter, SSA
Others
Margret Amatayakul, MBA, RHIA, Margret\A Consulting, LLC
Matthew Albright, CMS
Peter Barto, PWC
Larry Casalino, M.D., Ph.D., Weill Cornell Medical College
Lauren Fleeyer, VA
Stephanie Jamison, HIMSS
Devin Jopp, Ed.D., WEDI
TerriPostma, M.D., CMS
Mari Savickis, AMA
Nancy Spector, R.N., M.S.C., AMA
Maria Cora Tracy, CMS/DEM
Kelley Turek, AHIP
Leah Vaughan, Ph.D., The Health Policy Group
(Please refer to Detailed Summary below or transcript for further information)
CALL TO ORDER, WELCOME, INTRODUCTIONS, AGENDA REVIEW
Walter G. Suarez, M.D., M.P.H. and W. Ob Soonthornsima, Co-Chairs
The discussion will explore the future in terms of data needs, exchanges and standards.
Facilitation and Ground Rules Kathy O'Connor, M.P.H.
Framing the Issues – Introductory Remarks Roundtable Discussion
Participants responded to the following question: ideally, what will information exchange between providers and payers look like in five to ten years?
Information exchange is driven by business purpose. Ideas must come from how clinical and non-clinical data, knowledge and analysis interpret and measure effectiveness of care while considering economic investments and ability to make cost-based decisions about healthcare delivery. The role of payers was raised as more organizations move into ownership of total medical expense and quality of care ("covered" vs. "siloed" care). The focus should be on efficient information flow. Software is not keeping up with the development of standards. Methods of saving money were suggested.
Characteristics and challenges of information exchange were described as were the value and changing nature of HIEs and the evolving role of payers. Semantic interoperability techniques help care teams share an understanding of patient issues. Such a data model can be used and leveraged in real time and on a population basis to optimize care and achieve the Triple Aim. It is useful to identify expected outcomes; how to get there (including roles and coordination); cost drivers; and how standards fit into the equation. Interoperable data available in real time improves consumer health and safety while engaging consumers more effectively. Consumer data sets such as biometric and social media goals are often not discussed. The Committee must look beyond payer needs; and a "roadmap" for the entire community should be consolidated. Despite the meaningful use program, much is not covered by these standards.
Communication tools are needed for efficiency (example given). Systems must catch up with increasingly technically savvy patients and providers and more evaluation is needed. Will data be seen as a common good or as a competitive weapon? The ecosystem must standardize the "right" things with an approach that is dynamic, responsive and incremental. Standards must be iteratively updated; substitutability (replacing bad solutions); and an aggressive approach to managing risk in the deployment of standards are recommended. Carnegie Mellon's Capability Maturity Model integration tool was suggested as an industry-wide approach to address needed changes. Future goals should include the creation of data journeys.
Additional challenges were cited to include how to encourage the market; how to allocate responsibility for infrastructure support; and funding mechanisms. Much can be done by consolidating, cutting down silos and breaking down fragmentation. Resources to measure impact will strengthen the case for meaningful change. Who, in addition to representative employers, is not at the table? It is predicted that, in the future, information market demand will be ahead of an ability to deliver it. Processes to use the information have not yet been developed in the market. Information must improve the quality of care and reduce costs. Great variation in usability of EHRs was noted. Infrastructure and training to support EHR use and ensure data accuracy were recommended. Implementation concerns were raised. The information ecosystem must be flexible enough in real time to meet emerging market demands. Patient trust and privacy protection in HIT is crucial to maintaining accuracy and value of clinical information.
The charge of NCVHS's Committeelies with administrative simplification, specifically, communication between payers and providers. The Committee should consider addressing data issues beyond administrative functions under HIPAA as the same data is used for clinical exchange. Transformational changes in the healthcare market at the federal level were noted as were increased burdens on providers and the shift of payment for individual services to payment in bundles. Cost and lack of adequate compensation are big concerns of practicing physicians. For the first time, increased demands are contributing to physician resistance to participating in the new hospital care survey. Data stream harmonization, flexibility and consideration of end users are needed.
Pharmacy's 20-year involvementwith claims transmission and information exchange was discussed, including payment challenges. The cost of making such changes is so prohibitive that more physicians, especially those with small practices, might "fade away" rather than change. More training and attention should be paid to the "garbage in, garbage out" question, noting high intra- and inter-observer coding variability. The various uses of clinical code sets were described. The ideal HIT system is a smooth end-to-end process that goes from eligibility to claims payment that is uniform across the industry (which could be a driving force in standardization of all administrative issues). Some organizations use quality measures that are not coordinated with other entities. Roles and measures must be coordinated and priorities determined within the ongoing standards ecosystem. It was noted that a spike in EHR use since 2006 is connected to certification and incentives.
Policy Questions and Considerations Roundtable Discussion
Participants were asked to discuss structural, business and policy considerations; and to address questions about major information exchange changes between providers, payers and the major policy, business and structural drivers of the next five to ten years.
What must happen for the industry to see HIPAA requirements and meaningful use as part of an integrated whole? A new care paradigm is needed, especially with shifts from acute to home care or other post-acute care settings. Are health plans doing follow-up along with providers? Billing data, abstracted from clinical data, must be understood. Redefined roles must align with a more collective, coordinated approach with patient well-being at its core. Automated processes drive out costs. Providers are moving quickly toward patient-centered medical homes, ACO-related services and a new model for providing input and measuring quality. Payers and providers must come to terms with risk adjustment by 2014, which will drive a need for more information exchange.
Ms. Greenberg clarified the Committee's responsibilities in the administrative simplification area. She asked for feedback from non-government roundtable participants about how the Committee could be most helpful; and where ONC and CMS fit in. The need for harmonization (to some, a "roadmap") has been widely acknowledged. The Health IT Policy Committee has addressed meaningful use and how to link HIPAA. Meaningful use as a separate program will end. When this happens, an opportunity to integrate the spirit of meaningful use with robust parts of HIPAA will open up. HIPAA and HITECH rules address coordination. The 1996 rule was delineated. A single MAP policy within HHS that coordinates the needs of CMS, NCVHS, the ONC and the statistics is strongly recommended.
From a provider point of view, interoperable data standardization should occur at the national level. It has been helpful to use the EHR to coordinate care. Systems that talk to each other save money and lives and prevent errors. The Committee should identify their most important goals; create a roadmap around those goals; build in ways that track and measure ROI; and determine next steps. The functions of the Administrative Simplification Group within the Office of Enterprise Management and Office of eHealth Standards and Services of CMS were delineated as were new components of ACA. The industry would be better served by collaborative efforts that line up with statutorily-dictated deadlines. While industry efforts are underway to link code values, a method of championing them is needed.
Through the Stimulus Program and the HITECH act, ARRA has provided stimulus money as incentives. In addition, HITECH has extended a Bush era executive order giving ONC legislative authority to establish standard certification criteria and implementation guides for interoperability. The ability to establish standards through Executive Order 13410, which will persist well beyond the HITECH Act, can serve as a policy lever.
A concern was raised about moving forward with claims attachments when utilizing the same clinical information for Meaningful Use, Stage Two. Many providers and hospitals agree that collecting data (especially clinical) once is preferable. Gross assumptions are made about what the needs and data uses are (example given). The Committee could do an inventory of what is happening around meaningful use; and what is working to bring stakeholders together. If the Committee does such an inventory, leveraging that information could provide greater insight into what payers need from care delivery data.
Concerns about quality of care were raised. It was suggested that NCVHS consider a universal patient matching routine or resurrect the idea of a national patient identifier. The governance and harmonization of terminologies and classifications, raised as an issue with ONC and NCVHS since 2006, should be worked out jointly. Metadata will permeate administrative and clinical spheres. Bringing vendors into the equation would allow for standards to be implemented more quickly than through meaningful use. When vendors combine clinical and claims information, issues will arise with payment systems that differ from the American system. The more international standards and consensus and nationally accepted standards, the more individuals control their data and share in ways that don't always require one "big database in the sky."
Resolving patient identification is critical to exchange business among different health plans as well as for patient attribution and ACO- or patient-centered medical home settings. Without a standard, payers will invent one, which will increase costs. Relative to cost concerns, a recommendation was made for stakeholders to focus on use cases coming out of market changes; and to ensure a good ROI on use cases tied to market needs. Patient discomfort with data sharing at a national level and how to develop policies palatable to the American public were raised. Population-level analytics must take into account data standards, APIs and query methods that do not compromise privacy and security. Providing caregivers with tools that help them avoid repeat tests will help the system work more effectively and drive down costs. What educational frameworks or guidance materials about ground rules about best practices and stewardship are available?
HIEs will bring wide scale change, especially as employers use them more. How these systems might work within private industry was described. What patients and providers want was outlined. NCHS hopes to send analyzed data back to hospitals as an incentive. HIEs have subscription fees and are complicated. As partners in their care, consumers need access to their data in Meaningful Use, Stage Two. Consumer mediated exchange was raised as were the function of operating rules. If links were provided to a patient electronic data storage site and privacy issues addressed, a centralized national clinical database might not be necessary. Providers need "actionable information" from data. Access to full sharing within clinical relationships is necessary as well as an ability to transport information between systems.
Suggested Policy Priorities
Data quality and the need to eliminate errors are big concerns. From a Medicare perspective, standardizing the interface between reporting quality metrics and information supporting the calculation of those metrics in values-based purchasing initiatives is needed. Because true administrative simplification starts with software, vendors must be engaged with certification. Patient identifiers are critical because without them, data is not accessible to different stakeholders. Another key need is to harmonize the definition of data elements. The policy should standardize every element entered into the EHR. A suggestion was made to adopt a healthcare smart card. Standardization and a federal regulatory environment that allows for clinical information sharing is needed as are portability and transportability.
More discussion about priorities ensued, including how to support less sophisticated organizations on the administrative side. The Committee should determine a process that establishes governance and harmonization of clinical terminology, classification and metadata that address data integrity and exchange questions. The Committee was encouraged to think more broadly about how the pieces of the whole healthcare system fit together. Economic forces are leading to consolidation and more mergers.
A range of questions about data, national architecture, national reference vocabularies, patient outcome measures and process measures were asked. Out of these questions, the priority issue was to make healthcare data more uniform, accurate, valid, computerized and protected; and then to use it to improve efficiency and effectiveness of the whole system.
The challenge of access to affordable information that community health centers face was raised. The complexity of the current process was reiterated. Patient identification was mentioned as a priority for pharmacies because patients must be tracked. A physician participant thought that a patient ID on a smart card with an attached and continually updated face sheet (of accurate medication lists, allergies, family history, and diagnostic codes) would prevent errors.
Technical Questions and Considerations Roundtable Discussion
From a technical point of view, questions to consider include: How will information flow from healthcare reform on the care delivery and payment sides with the formation of view structures, ACOs and health information exchanges? What transactions should support the flow of information? How must enrollment and eligibility processes and standards change to align with a forward direction? In general, what transformative changes are needed in transactions and standards in health IT? How is EHR adoption changing information exchange opportunities between providers and payers?
WEDI has created an ACL bundled payment workgroup because the manual process of handling bundled payments must change. Aspects of Meaningful Use, Stage One, Two and Three were compared. Terminologies like SNOMED must be adopted to provide the necessary granularity (European countries are further along). A gap must be bridged in user interface (e.g., vendors and caregivers). Not everyone has the ability to use the full array of data components on claims. As operating rules (which improve how standards are use) get developed for other transactions such as claims, the hope is that organizations will build "edit logic" needed from codes contained on the UB. Functionality must be part of the process.
NCVHS must identify a manageable chunk of work. With a shift toward accountable care organizations and shared risk, now is a good time to refresh administrative transactions such as X12, 270 and 271 eligibility transactions. It was recommended that NCVHS assume responsibility for working through issues related to administrative transactions. Technology should not be a barrier. It might also be useful to think about APIs and services, which reflect a need for business harmonization around business operating rules. NCVHS should ask other committees for help (e.g., HIT Policy or Standards Committees).
The Subcommittee on Standards mandate (administrative simplification) was delineated as was a failure to recognize other uses of generated information (e.g., use of UB for more than quality measurement). According to the IOM, the technology is there but people have not necessarily been trained to use it. To achieve administrative simplification, the Committee must understand how to effectively use technology, standards and processes at the primary site.
Pharmacy compliance problems with prescription drug monitoring programs that use products that are not real time were described. The recommendation is for a "real-time world" for pharmacists and providers. Another suggestion was to look outside of health care for industry standards that support similar or related processes. Today's timeframes are different than they were when standards were first created approximately 16 years ago. A maintenance cycle must be developed that respects industry time needed to refresh and reconsider standards. Generally, a business need for high quality interoperable data in real time that lends itself to good analytics will only increase.
A successful 2005 pilot of the claim attachment standard between a New York practice and a Medicaid contractor was described. At present, the standard is due to be changed by 2016. The United States has not paid much attention to what other countries are doing. Movement from a fee-for-service to a values-based payment system maintains payment structures that do not reflect this shift (example given). Flexibility is needed.
The HIMSS Capability Maturity Model tracks EMR adoption trends across the industry. A huge gap was noted between organizations with exchange capability (example given). At present, only 25 percent of hospitals in the United States report participation in HIEs, up from five years ago at 11 percent. Innovation is needed for getting data into the system. As important, constituents must know how to use the systems that are in place and the process must be linked with all other industry changes. Maintaining and upgrading standards on a regular basis falls under the purview of the Committee. When the business case answers the question of competing organizations, "what is in it for me", developing or updating standards becomes easier and patients receive better care.
A continuous improvement process is needed for patient care and how to equip providers on the periphery with necessary tools and analytics. Changes must recognize patients as consumers and payers of health care. Incentivizing health care providers to supply data makes the system more efficient but some wondered whether receiving information about how they were doing would be sufficient payoff for providers. Limited resources to support these efforts were noted.
Suggested Technological Priorities
Transformative changes to standards and to technology are not interchangeable. No single model that includes financial and clinical quality metrics can calculate true ROI. A standardized methodology that measures real ROI (including financial, business and clinical metrics) would be useful. Qualitative improvements include patient safety, proactive consumer health and better outcomes. It is important for companies to remain open to innovations (e.g., Cloud services; APIs) and aware of what others are doing to create information ecosystems.
National economics and politics must align with improving efficiency and effectiveness of the health care system to maintain quality and achieve other national goals. Health care should adopt a remote distributive processing model, which is quite common in other fields. This will only happen if the architecture is defined to do that. A big consideration is how to interoperate with content or payload to produce information in real time (Wal-Mart is an example of where this is done). It is important to know the customer. Physician practices want to know how they compare with their peers. The Committee could showcase organizations that are ahead of the curve in using data innovatively. The most innovative technology for administrative simplification will come from the marketplace. Perhaps NCVHS can expand its role of making standard adoption recommendations to the government to non-governmental organizations. Could the Committee accelerate voluntary adoption in addition to examining the regulatory process? It is difficult to push voluntary efforts in the industry. The importance of real time was reiterated. Government enforcement is critical to bringing together convergent elements within the industry. A question was posed about what it will take to make the technology simpler for the end user.
Walter G. Suarez, M.D., M.P.H. and W. Ob Soonthornsima, Co-Chairs
Mr. Soonthomsima summarized common themes:
Other areas of consideration included: a need for more effective certification to accelerate alignment of data needs with system usability. The need for standard terminologies and common definitions was stressed to include harmonizing and improving terminologies; and coding data from correct definitions and standards. Since a more granular dataset or standards may not necessarily translate into effective data capturing, it is important to ensure that workflow changes occur effectively as standards are being rolled out.
Standards development should be harmonized across the industry to focus on values and to be timely. Coordination and collaboration is needed across the industry, to include an alignment of policies, mandates and initiatives in order to drive cost and quality improvements. Other issues raised had to do with data quality; standardizing the interface between quality metrics; a seamless exchange between all entities; certification; how to codify data standards definitions at the point of care in the EHR system; use of a smart card to make access easier for consumers; educating constituents on the value of what they must implement; minimal datasets; incentives; and voluntary versus mandatory steps to drive change.
Next Steps: In the next few months, the Subcommittee will summarize priorities and recommendations taken from the roundtable discussion. A presentation will be given to the full Committee at the February 2013 meeting. Future meetings, virtual and in-person, may be held to discuss NCVHS priorities. Communication will be via email. A "roadmap" that aligns processes is of special interest to the Subcommittee, the full Committee and many agencies such as ONC, CMS and others, as is an understanding of where current standards and the work of HIPAA and the Affordable Care Act fit in.
A letter report with recommendations is not on the agenda as the roundtable discussion is a starting point for the Subcommittee's work over the next year.
CALL TO ORDER, WELCOME, INTRODUCTIONS, AGENDA REVIEW
Walter G. Suarez, M.D., M.P.H. and W. Ob Soonthornsima, Co-Chairs
Dr. Suarez provided background on the reason for the discussion, noting 15 years of HIPAA, the evolution of the adoption of EHRs and health IT standards, the movement toward HIEs and interoperability. Health reform will transform health care delivery and reimbursement structures. Greater efficiency is sought by federal and state governments for health care, health information and HIEs. The convergence of standards that are adopted and implemented for administrative and clinical processes is another area to address. Information exchange will be critical – between providers, providers and health plans and others in the industry, including public health. Changes in the demand for health information require adjustments in how standards (e.g., HIPAA; Affordable Care Act; HITECH; Meaningful Use)meet requirements.
What will the future look like in terms of data needs, exchanges and standards? This discussion is the beginning of a dialogue. Examining next steps and future opportunities is a priority for the entire National Committee (note distributed background document to review the broad agenda and, at a future point,consider specific questions). Mr. Soonthornsima also welcomed participants, stressing convergence as a key theme and noting that the primary concern is patient welfare.
Facilitation and Ground Rules Kathy O'Connor, M.P.H.
Specific timeframesand structures were described for each segment of the roundtable discussion.
Framing the Issues – Introductory Remarks Roundtable Discussion
Participants responded to the following question: ideally, what will information exchange between providers and payers look like in five to ten years?
Information exchange is driven by business purpose. Ideas must come from how clinical and non-clinical data, knowledge and analysis interpret and measure effectiveness of care while considering economic investmentsand ability to make cost-based decisions about healthcaredelivery. A question was posed about the payer role as more organizations move into ownership of total medical expense and quality of care ("covered" vs. "siloed" care). One participant thought there would be littledifference between now and five to ten years in the future. The focus, then, should be to ensure an efficient information flow. Software is not keeping up with the development of standards. Money can be saved with a centralized industry-based solution through CMS or the states. An article in the Nov. 15, 2012 New England Journal of Medicine identified six areas where standardization could reduce costs, including credentialing. It was estimated that those six areas could reduce administrative costs at a rate of $29,000 per physician per year.
Three characteristics of information exchange to be considered in five to ten years include: 1) national quality strategy, which guides what is being done at a national level; 2) building a common data infrastructure to be used for care delivery, quality of care measurements and quality improvement as well as in administrative and financial areas; and 3) patient-centered data collection, in which information is collected once but used for multiple purposes. Information exchange might also include holistic data about outcomes, in which information is shifted from administrative to administrative and clinical in real time. In the future, there will be an enhanced partnership between all levels of the delivery system, including the payer group. Additional areas to consider arereal time or concurrent exchange and best practices (i.e., Triple Aim);and retrospective or aggregate exchange that examines practice patterns, costs over time and how particular patient types are managed by particular organizations.
HIEs create value through support of underlying business processes. The role of payer must evolve from supporting traditional financial and administrative areas to include clinical decision-making and population-based analytics. Such an evolution requires a different type of HIE, not simply an electronic clearinghouse for claims processing. All transactions in the clinical and administrative environment create a human understanding of the patient.Semantic interoperability techniques help care teams share an understanding of patient issues.Such a data model can be used and leveraged in real time and on a population basis to optimize care and achieve the Triple Aim.
It is useful to identify expected outcomes; how to get there (including roles and coordination); cost drivers; and how standards fit into the equation. Not everyone embraces standards in meaningful ways. Interoperable data available in real time improve consumer health and safetywhile engaging consumers more effectively. At present, certain consumer data setscritical to achieving information ecosystem end goals (e.g. biometric, social media) are often not discussed. The Committee must look beyond payer community needs; and a "roadmap" for the entire community should be consolidated. Even if the data arepresent, it is not clear that they use the same language. Despite the meaningful use program, which establishes standard criteria for certain products, much that not covered by these standards.
An ability to communicate without much manual intervention is important. Tools are needed to help different parties be more efficient. For example, no indicators communicate about bundled payments between the payer and provider communities.Systems must catch up withincreasingly technically savvy patients and providers. More evaluation will help determine what is working, understanding that no solution will be ‘one size fits all'. Will data be seen as a common good or as a competitive weapon? The ecosystem must standardize the "right" things to create an innovative environment. The approach must be dynamic, responsive and incremental. Standards must be iteratively updated. Substitutability will allow for swapping out bad solutionsfor good ones. An aggressive approach to managing the risk in how standards are deployed is necessary.
Carnegie Mellon's Capability Maturity Model integration tool was recommended as an industry-wide approach to address needed changes. This model promotes cooperation and addresses change agent needs. Future goals should include the creation of data journeys - the seamless transition of data from one care setting to another. Data journey gaps were described in the Medicare Short Savings Program and other ACO initiatives (e.g., from the lab or the imaging center to the medical chart).
Challenges include how to encourage the market while moving away from a proprietary point of view.Much can be done by consolidating, cutting down silos and breaking down fragmentation. Private sector and government roles must be examined. Other concerns have to do with allocating responsibilities in ways that support the infrastructure; and determining funding mechanisms. Time and resources to measure the impact of whatever is done will strengthen the case for meaningful changefor system users. Who, in addition to representative employers, is not at the table? It is important to predict demand. It is predicted that future information market demand will be ahead of an ability to deliver itdespite the fact that the reverse is true in the current start-up phase. Processes to use the information have not yet beendeveloped in the market.
Data about patients and patient care are not useful unless proven to be correct and accurate. Great variation in usability of EHRs was noted. Infrastructure and training must support EHR use and ensure data accuracy. Information must improve the quality of care and reduce costs. One participant noted that policy trumps technology. Implementation is a challenge for the industry, caregivers and patients as is redefining information sources beyond EHRs (e.g. infusion pumps, ventilators).
What is needed to create a more interoperable information ecosystem that anticipates market needs? The information ecosystem must be flexible enough in real time to meet emerging market demands. Can the group agree to principles that ensure a functional foundational information system? Patient trust and privacy protection in HIT is crucial to maintaining accuracy and value of clinical information.
The charge of NCVHS's Committee lies with administrative simplification, specifically, communication between payers and providers. The Committee should consideraddressing data issues beyond administrative functions under HIPAA as the same data is used for clinical exchange.Changes in the healthcare market aretransformational at the federal level. In the past eight to ten years, the process by which providers have been asked to provide information has been burdensome.The shift of payment for individual services to payment in bundles must be refined. Not everything can be accomplished at once. Federal programs must be coordinated and the industry must act on what has real and meaningful value. Cost and lack of adequate compensation are big concerns of practicing physicians.Provider buy-in is critical. For the first time, increased demands arecontributing to physician resistance to participating in the new hospital care survey. The hopeis that in five to ten years, such surveys will provide a picture of health care delivery across divides but this mission is in jeopardy due to low participation rates. Data stream harmonization, flexibility and consideration of end users are needed.
Pharmacy has been doing claim transmission and information exchange for 20 years. Although the process can be burdensome, it is good for the patient. It is important to get the "right" people into the "right" room. The fear is that the cost of making such changes is so prohibitive that more physicians, especially those with small practices, will "fade away" rather than change. Pharmacies managing medication therapy for patients with multiple medications do not get paid for that service. Are the "right" providers getting paid the "right" fees for what they provide?
More training and attention should be paid to the "garbage in, garbage out" question, noting high intra- and inter-observer coding variability.Finely granular clinical code sets more accurately describe a patient's current clinical state; but consideration must also be given to how the codes are rolled up into coarser units for purposes such as quality management. HIT systems support communication among disparate caregiversand exchange structured data (e.g., communication between pathologists and radiologists when diagnosing a cancer stage). The ideal is a smooth end-to-end process that goes from eligibility to claims payment that is uniform across the industry. The industry could be a driving force in standardization of all administrative issues. Some organizations use quality measures that are not coordinated with other entities. It is important to understand roles and determine priorities within the ongoing standards ecosystem. It was noted that a spike in EHR use since 2006 is connected to certification and incentives, which has not happened on the administrative side.
Policy Questions and Considerations Roundtable Discussion
Participants were asked to discuss structural, business and policy considerations; and to address questions about major information exchange changes between providers, payers and the major policy, business and structural drivers of the next five to ten years. Consideration should also be given to upcoming information exchange needs between providers and payers (noting changes in reimbursements, enrollment and eligibility processes). Dr. Suarez noted that the best thing that has happened to HIPAA is Meaningful Use. The industry's push to adopt EHRs ensures that providers have the information they need to deliver quality patient care. In addition, health reform is contributing to a more interoperable system.
HIPAA requirements and meaningful use are siloed. What must happen for the industry to see these two mechanisms as part of an integrated whole? A new care paradigm is needed, especially with shifts from acute to home care or other post-acute care settings. Are health plans doing follow-up along with providers? Billing data, abstracted from clinical data, must be understood. Redefined roles must align with a more collective, coordinated approach with patient well-being at its core. End users must successfully use the developed standards and processes. Automated processes drive out costs. Providers are moving quickly toward patient-centered medical homes, ACO-related services and a new model for providing input and measuring quality. Payers and providers must come to terms with risk adjustment by 2014, which will drive a need formoreinformation exchange.
Ms. Greenberg clarified that the Committee has a strong responsibility in the administrative simplification area. The Population Health Committee is addressing ways to empower communities to improve health. She asked for feedback from non-government roundtable participants about how the Committee could be most helpful; and where ONC and CMS fit in. The need for harmonization (to some, a "roadmap") has been widely acknowledged.
The Health IT Policy Committee has discussed (in writing) meaningful use and how to link HIPAA. With respect to privacy and security components of meaningful use, a deliberate decision was made to keep them separate. Various groups opposed this decision and it now appears that meaningful use as a separate program will end. When this happens, an opportunity to integrate the spirit of meaningful use with robust parts of HIPAA will open up. HIPAA and HITECH rules address coordination. The 1996 rule stipulates that the Secretary can designate other standards to improve administrative simplification, whether financial or clinical. This area has not been explored. A single MAP policy within HHS that coordinates the needs of CMS, NCVHS, the ONC and the statistics is strongly recommended.
From a provider point of view, interoperable data standardization should occur at the national level. It has been helpful to use the EHR to coordinate care. Systems that talk to each othersave money and lives and prevent errors. The Committee should identify their most important goals; create a roadmap around those goals; build in ways that track and measure ROI; and determine next steps.
The functions of the Administrative Simplification Group within the Office of Enterprise Management and Office of eHealth Standards and Services of CMS were delineated. ACA has several new components, including a compliance certification requirement for health plans; a health plan identifier and another entity identifier; and operating rules around transactions. The industry would be better served by collaborative efforts that line up with statutorily-dictated deadlines. There is an opportunity for Meaningful Use, Stage Two. While industry efforts are underway to link code values, a method of championing them is needed.
Through the Stimulus Program and the HITECH act, ARRA has provided stimulus money as incentives. In addition, HITECH has extended aBush era executive order giving ONC legislative authority to establish standard certification criteria and implementation guides for interoperability. The ability to establish standards through Executive Order 13410, whichwill persist well beyond the HITECH Act, can serve as a policy lever.
A concern was raised about moving forward with claims attachments when utilizing the same clinical information for Meaningful Use, Stage Two. Such information is not sufficiently detailed nor does it sustain processes that need support. If evidence-based medicine were provided at the point of care with clinical decision support, there would be less need to discuss risk management and administrative simplification. One participant mentioned that many providers and hospitals agree that collecting or accumulating data (especially clinical) once is preferable. While data standardization is important to harmonization, equally important is for stakeholders to come together to discuss why they need the data and what they will do with them. Gross assumptions are made about what the needs and data uses are (example given). The Committee could do an inventory of what is happening around meaningful use; and what is working to bring stakeholders together. If the Committee does an inventory of what has worked from a policy perspective, leveraging that information could provide greater insight into what payers need from care delivery data.
Concerns about quality of care were raised relative to cost and an erosion of the patient-physician relationship due to business decisions. Future changes in payment models and patient identification are areas of consideration. It was suggested that NCVHS consider a universal patient matching routine or resurrect the idea of a national patient identifier. While the annual appropriations bill specifies that HHS should not touch patient identification, it has gone around this rule and hasheld discussions on this issue. The governance and harmonization of terminologies and classifications, raised as an issue with ONC and NCVHS since 2006, should be worked out jointly. In addition, metadata will permeate administrative and clinical spheres. How to address vendors is another crucial element because they are not hearing the call for independent providers who purchase their services. Bringing them into the equation would allow for standards to be implemented more quickly than through meaningful use. The vendor environment of the United States and England were compared. When vendors combine clinical and claims information, issues will arise with payment systems that differ from the American system.
Resolving patient identification is critical to exchange business among different health plans as well as for patient attribution and ACO- or patient-centered medical home settings. Without a standard, payers will invent one, which will increase costs. Relative to cost concerns, a recommendation was made for stakeholders to focus on use cases coming out of market changes; and to ensure a good ROI on use cases tied to market needs.
Patient discomfort with data sharing at a national level was raised, begging the question of how to develop policies that are palatable to the American public. Population-level analytics must take into account data standards, APIs and query methods that do not compromise privacy and security. It is important to understand the need of populations for particular services. Routines for efficiently collecting and understanding data and giving caregivers tools to help them avoid repeat tests will help the system work better and drive down costs. A question was raised about the availability of educational frameworks or guidance materials about ground rules that could provide information about best practices and stewardship.
While standards are not perfect, they offer interoperability that drives democratization. The "big database in the sky" becomes the repository for a multitude of data from different sources that organizations use for analytics. What will natural language processing mean in the future for centralized "big" data and analytics? The more international standards and consensus and nationally accepted standards, the more individuals control their data and share in ways that don't always require one large source of analytic capability.
HIEs will bring wide scale change. Employers are starting to understand and use HIEs (e.g., Sears). How these systems might work within private industry was described, with references made to John Casillas, founder of the Medical Banking Project. There was further discussion about what patients and providers want. Patients want to know that their data are protected and how they are used. Providers want a simple and inexpensive process. NCHS hopes to send analyzed data back to hospitals as an incentive. HIEs have subscription fees and are complicated. Exchange with patients should be structurally built in. As partners in their care, consumers need access to their data in Meaningful Use, Stage Two. Consumer mediated exchange was raised. It was noted that CMSand others provide consumers with comparison data about physicians, hospitals and nursing homes on the web. Maintaining data integrity is a challenge.
Operating rules call for an examination of data end use and standards. Consensus operating rules must be established for how data are transferred from the point of collection totheir various uses. It was suggested that, if links were provided to where a patient's electronic data are stored andprivacy issues addressed, a centralized national clinical database might not be necessary. This could be framed as a patient safety issue as much as a privacy concern. Providers need"actionable information" from data. Access to full sharing within clinical relationships is necessary as well as an ability to transport information from system to system.
Suggested Policy Priorities
There were a variety of responses to the question of what the Committee should address in terms of policy. Data quality and the need to eliminate errors are big concerns. From a Medicare perspective, onegreat need in values-based purchasing initiatives has to do with standardizing the interface between reporting quality metrics and information supporting the calculation of those metrics. Because true administrative simplification starts with software, vendors must be engaged with certification as an important part of the process. Patient identifiers are critical because data can't be accessible to different stakeholders without them. Another key area is to harmonize the definition of data elements.The policy should standardize or codify every element that is entered into the EHR. A suggestion was made to adopt a smart card for use in health care. Standardization and a federal regulatory environment that allows for clinical information sharing among individual organizations involved with the patient is needed, as are portability and transportability.
More discussion about priorities ensued. A question arose about how to support less sophisticated organizationson the administrative side. A suggestion was made for the Committee to determine a process that establishes governance and harmonization of clinical terminology, classification and metadata that address data integrity and exchange questions. The Committee was encouraged to think more broadly about how the pieces of the whole healthcare system fit together. Economic forces are leading to consolidation and more mergers.
Questions asked included: What data are needed for large medical healthcare delivery systems? What national architecture should lead the country in coalescing information (e.g., longitudinal, from providers; cost and payment; standards; gaps) and what national reference vocabularies should pull a data model together (including privacy and security protections)? What patient outcome measures and process measures are effective? What research would lead to improved patient outcomes? How should incentives be changed? Out of these questions, the priority issue was to make healthcare data more uniform, accurate, valid, computerized and protected; and then to use it to improve efficiency and effectiveness of the whole system.
The challenge that community health centers face with affordable information access was raised.The complexity of the current process was reiterated, emphasizing a need to define the course of the data while improving quality and reliability. Patient identification was mentioned as a priority from a pharmacy point of view because patients must be tracked. A physician participant thought that a patient ID on a smart card with an attached and continually updated face sheet (of accurate medication lists, allergies, family history, and diagnostic codes) would prevent errors.
Technical Questions and Considerations Roundtable Discussion
From a technical point of view, it is important to think about transactions in new ways. Questions to consider include: How will information flow from healthcare reform on the care delivery and payment sides with the formation of view structures, ACOs and health information exchanges? What transactions should support the flow of information? How must enrollment and eligibility processes and standards change to align with a forward direction? In general, what transformative changes are needed in transactions and standards in health IT? How is the adoption of EHRs changing information exchange opportunities between providers and payers?
WEDI recently created an ACL bundled payment workgroup because the current manual process of handling bundled payments must change. While current Meaningful Use, Stage One and Stage Two requirements do not provide non-transactional specifics about a patient's progress, proposed changes in Stage Three give more information about health status. Terminologies like SNOMED must be adopted to provide the necessary granularity (European countries are further along). A gap must be bridged in user interface (e.g., vendors and caregivers). Operating rules improve howstandards are used. Not everyone has the ability to use the full array of data components on claims, noting that some information on the 837 institutional is not fully utilized. As operating rules are developed for other transactions such as claims, the hope is that organizations will build the type of "edit logic" that is needed from the codes contained on the UB. Functionality must be part of the process.
It is important for NCVHS to identify a manageable chunk of work rather than taking on too much. With a shift towards accountable care organizationsand shared risk, this is a good time to refresh administrative transactions such as X12, 270 and 271 eligibility transactions. It was recommended that NCVHS assume responsibility for working through issues related to administrative transactions. Technology should not be a barrier. It might also be useful to think about APIs and services, which reflect a need for business harmonization around business operating rules. These things must be translated into the technology. NCVHS should ask other committees for help (e.g., HIT Policy or Standards Committees).
The Subcommittee on Standards was partially set up to examine administrative simplification but with some transactions applied to primary provider sites, there is a failure to recognize that information generated has other uses (e.g., use of UB for more than quality measurement). According to the IOM, the technology is there but people have not necessarily been trained to use it. To achieve administrative simplification, the Committee must understand how to effectively use technology, standards and processes at the primary site.
Pharmacy compliance problems with prescription drug monitoring programs that use products that are not real time were described (pharmacies operate with real time eligibility and drug information between payers and providers). NCPDP recently held a focus group to discuss this dilemma. The recommendation is for a "real-time world" that pharmacists and providers can use. Another suggestion was to look outside of health care for industry standards that support similar or related processes. Today's timeframes are different than they were when standards were first created approximately 16 years ago. A maintenance cycle must be developed that respects industry time needed to refresh and reconsider standards. Generally, a business need for high quality interoperable data in real time that lends itself to good analytics will only increase. Agile development of new standards that meet business needs will be critical.
A successful 2005 pilot of the claim attachment standard between a New York practice and a Medicaid contractor was described. Although both sides saved money, nothing was done in response to the pilot. At present, the standard is due to be changed by 2016. The United States has not paid much attention to what other countries are doing although there is much to be learned about what works. Movement from a fee-for-service to a values-based payment system maintains payment structures that do not reflect this shift (e.g., coordination of care for multiple diagnoses is not reimbursed because this work is not documented). Flexibility is needed that allows for a continuation of what works as systems evolve.
The HIMSS Capability Maturity Model tracks EMR adoption trends across the industry. A huge gap was noted between organizations with exchange capability (e.g., Tucson Medical Center; Adventist Health System). At present, only 25 percent of hospitals in the United States report participation in HIEs, up from five years ago at 11 percent. Innovation is needed for getting data into the system. As important, constituents must know how to use the systems that are in place. Relative to the ACA requirement to improve standards updating (especially under HIPAA), the process must be linked with all other industry changes for other requirements. Maintainingand upgrading standards on a regular basis falls under the purview of the Committee. When the business case answers the question of competing organizations, "what is in it for me", developing or updating standards becomes easier and patients receive better care.
A continuous improvement process is needed forpatient care and how to equip providers on the periphery with necessary tools and analytics.Changes must recognize patients as consumers and payers of health care. Incentivizing health care providers to supply data makes the system more efficient but some wondered whether receiving information about how they were doing would besufficient payoff for providers. Limited resources to support these efforts were noted.
Suggested Technological Priorities
Transformative changes to standards and to technology are not interchangeable. No single model that includes financial and clinical quality metrics can calculate true ROI. A standardized methodology that measures real ROI(including financial, business and clinical metrics) would be useful. Qualitative improvements include patient safety, proactive consumer health and better outcomes. It is important for companies to remain open to innovations (e.g., Cloud services; APIs) and aware of what others are doing to create information ecosystems.
National economics and politics must align with improving efficiency and effectiveness of the health care system to maintain quality and achieve other national goals. Health care should adopt a remote distributive processing model, which is quite common in other fields. This will only happen if the architecture is defined to do that. A big consideration is how to interoperate with content or payload to produce information in real time (Wal-Mart is an example of where this is done).It is important to know the customer. Physician practices want to know how they compare with their peers. The Committee could showcase organizations that are ahead of the curve in using data innovatively. The most innovative technology for administrative simplification will come from the marketplace. Perhaps NCVHS can expand its role of making standard adoption recommendations to the government to non-governmental organizations. Could the Committee accelerate voluntary adoption in addition to examining the regulatory process?It is difficult to push voluntary efforts in the industry. The importance of real time was reiterated.
One participant noted that government enforcement is critical to bringing together convergent elements within the industry. The unwieldy process imposed upon providers was again noted. A question was posed about what it will take to make the technology simpler for the end user.
Next Steps
Walter G. Suarez, M.D., M.P.H. and W. Ob Soonthornsima, Co-Chairs
Mr. Soonthomsima summarized common themes:
Other areas of consideration included: a need for more effective certification to accelerate alignment of data needs with system usability. The need for standard terminologies and common definitions was stressed to include harmonizing and improving terminologies; and coding data from correct definitions and standards. Since a more granular dataset or standards may not necessarily translate into effective data capturing, it is important to ensure that workflow changes occur effectively as standards are being rolled out.
Standards development should be harmonized across the industry to focus on values and to be timely. Coordination and collaboration is needed across the industry, to include an alignment of policies, mandates and initiatives in order to drive cost and quality improvements. Other issues raised had to do with data quality; standardizing the interface between quality metrics; a seamless exchange between all entities; certification; how to codify data standards definitions at the point of care in the EHR system; use of a smart card to make access easier for consumers; educating constituents on the value of what they must implement; minimal datasets; incentives; and voluntary versus mandatory steps to drive change.
Next Steps: In the next few months, the Subcommittee will summarize priorities and recommendations taken from the roundtable discussion. A presentation will be given to the full Committee at the February 2013 meeting. Future meetings, virtual and in-person, may be held to discuss NCVHS priorities. Communication will be via email. A "roadmap" that aligns processes is of special interest to the Subcommittee, the full Committee and many agencies such as ONC, CMS and others, as is an understanding of where current standards and the work of HIPAA and the Affordable Care Act fit in.
A letter report with recommendations is not on the agenda as the roundtable discussion is a starting point for the Subcommittee's work over the next year.
Adjournment: 1:00 p.m.
To the best of my knowledge, the foregoing summary of minutes is accurate and complete.
Walter G. Suarez, M.D., M.P.H. DATE December 26, 2012
Co-Chairman
W. Ob Soonthornsima DATE December 26, 2012
Co-Chairman