Department of Health and Human Services

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

January 9-10, 2018

Hubert H. Humphrey Building, Washington, DC

MEETING MINUTES

Note: Please refer to the transcript and slides for details on this meeting, posted at ncvhs.roseliassociates.com. Transcripts are linked to the meeting calendar; slides are linked to the agenda.

The National Committee on Vital and Health Statistics was convened on January 9-10, 2018, at the Department of Health and Human Services’ Hubert H. Humphrey Building in Washington, DC. The meeting was open to the public. Present:

Committee Members

William W. Stead, MD, Chair

Bruce Cohen, PhD

Nicholas Coussoule

Llewellyn Cornelius, PhD

Alexandra Goss

Linda Kloss, RHIA, CAE, FAHIMA

Richard Landen, MPH, MBA

Denise Love

Vickie Mays, PhD, MSPH (by phone)

Jacki Monson, JD

Bob Phillips, MD

David Ross, ScD

Debra Strickland, MS

Roland Thorpe, PhD

Lead Staff and Liaisons

Rebecca Hines, MHS, NCHS, Executive Secretary/DFO

Kate Brett, PhD, NCHS

Lorraine Doo, MPH, CMS

Geanelle Herring, MSW, CMS

Rachel Seeger, MPA, MA, OCR

Vickie Boothe, CDC (by phone)

 NCVHS Staff

Debbie Jackson, MA, NCHS

Marietta Squire, NCHS

Geneva Cashaw, NCHS

Lorraine Doo, CMS

 Others (not including presenters)

Suzie Bebee, ASPE

Maya Bernstein, ASPE

Donna Pickett, NCHS

Chris Gearhart, CMCS

Vivian Auld, NLM

Bob Gellman, contractor

Rose Li, contractor

Susan Baird Kanaan, contractor

Samuel Thomas, contractor

Ruth Bennett, contractor

Michele Dillon, contractor

Gib Parrish, MD (by phone)

Gail Kocher, BCBSA

Michael Decarlo, BCBSA

Jessica Porras, CAQH

Nancy Spector, AMA

Charles Stellar, WEDI

Erin Weber, CAQH

Joe Bormel, JIBB

 

ACTIONS

  1. The Committee passed a motion approving the environmental scan report, “Health Information Privacy Beyond HIPAA: A 2018 Environmental Scan of Major Trends and Challenges,” written for NCVHS by Robert Gellman under contract, subject to final copy editing, to be posted on the NCVHS website.

 

  1. The Committee passed a motion approving the report, “Vital Records and Vital Statistics in the United States: Uses, Users, Systems, and Sources of Revenue,” written for NCVHS by Gibson Parrish, MD under contract. An explanation will be added regarding how this report fits within the broader body of NCVHS work on the next generation vital statistics topic.

 

―DAY ONE―

Welcome and Agenda Review―Dr. Stead

After reviewing the agenda, Dr. Stead asked for updates from Committee members.

Committee Updates

Ms. Hines reported that the Institute for Healthcare Improvement’s 100 Million Lives group established workgroups that are developing candidate measures for the Measurement Framework for Community Health and Well-being developed by NCVHS.

There were several announcements regarding personnel. Ms. Hines reported that Dr. Rippen has resigned from the Committee to take a position as Deputy Director of the DoD/VA Interagency Program Office responsible for ensuring electronic health record interoperability for the military. Ms. Hines and several members expressed gratitude for Dr. Rippen’s contributions to NCVHS. Ms. Hines noted that the Committee now has four vacancies, and she invited people to send suggestions for new members. Dr. Stead acknowledged the retirement of Katherine Jones, a long-time and pivotal member of the NCHS team that staffs NCVHS. He expressed the Committee’s great appreciation for her service. Ms. Kloss expressed gratitude for the work of Maya Bernstein, who has stepped down as lead staff to the Subcommittee on Privacy, Confidentiality and Security after 13 years of service, and will remain involved as a subject matter expert. She welcomed Rachel Seeger as the new lead staff to the Subcommittee.

NCVHS Workplan

Dr. Stead noted that the workplan “has evolved a lot.” He described the document outlining the plan, commenting on each major project and the items in the “parking lot.” The Patient Matching Initiative and Prior Authorization End-to-End were removed from the workplan.

Ms. Hines reported that the 21st Century Cures Act directed the Secretary to convene a working group to study and report on uses and disclosures of protected health information for research purposes, and HHS is exploring whether NCVHS might take on this assignment instead of creating a new federal workgroup or committee.

As to the process, Dr. Stead noted that NCVHS is using substantial blocks of the full Committee meeting to work on key priorities in the workplan, as in the present meeting.

Beyond HIPAA Environmental Scan―Ms. Kloss, Chair, Subcommittee on Privacy, Confidentiality, and Security

This session began with a review of the environmental scan report, “Health Information Privacy Beyond HIPAA: A 2018 Environmental Scan of Major Trends and Challenges,” written for NCVHS by Robert Gellman under contract. Several members praised the report as a thorough, graduate-level presentation of the topic. After pondering the challenge of defining health information, they reviewed the report section by section, discussed follow up topics with Mr. Gellman, and proposed no substantive changes. The Committee then passed a motion approving the report, subject to the usual final copyediting, for posting on the NCVHS website.

The Committee then discussed a set of “candidate problem cases” that the Subcommittee on Privacy, Confidentiality and Security might address moving forward. Ms. Kloss commented first on the topic of registries, on which former NCVHS member Dr. Leslie Francis has recently done research. For transparency, Dr. Phillips noted a potential conflict in that he leads a national clinical registry. The group considered how to define the scope of the topic to be both sufficiently broad and yet manageable. It was noted that the topic is relevant to several current NCVHS projects. Another candidate problem case for the Subcommittee concerns consumer devices, and members briefly discussed the possibility of looking at both topics as a set because of the similar privacy issues they raise.

Predictability Roadmap―Ms. Goss and Mr. Coussoule, Co-Chairs, Subcommittee on Standards (slides)

This session was both an update on the Predictability Roadmap project and a priming of discussion for the subsequent session on the CIO Forum. As the value proposition, Ms. Goss noted that updates to and adoption of standards and operating rules have not kept pace with the evolving business, operations, and technology challenges, and needs of health care stakeholders. Therefore, NCVHS is collecting information to guide recommendations toward improvements in flexibility and responsiveness.

To date, the Subcommittee has gathered inputs from stakeholders, produced and shared a summary of findings, held an appreciative inquiry visioning workshop (August 2017), produced a summary report, defined the conceptual framework and “general direction” for future work, and held a session with Standards Development Organizations. The Subcommittee’s goal, drawing on past and future efforts, is to develop recommendations for vetting by the full Committee. Mr. Coussoule invited comments and suggestions from NCVHS colleagues.

Ms. Goss commented on each of the five themes that arose in the appreciative inquiry workshop, which reflect areas in which predictability is needed: standards development processes, standards adoption governance, data harmonization, the federal adoption process, and covered entity designations. In response to a question, she explained what specific standards are the focus, adding that future presentations―e.g., at the CIO Forum―would make those boundaries explicit. It was noted that there is relevant language in the 12th NCVHS Report to Congress on HIPAA Implementation.

Ms. Goss said that the Subcommittee has been honing its framing language and slides for use in the CIO Forum. Dr. Stead remarked that the distillation is “a dramatic advance,” and today’s presentation should be useful in developing future products. Asked about the planned staging and timing of provisional recommendations, the co-chairs said the Subcommittee wants to get the CIOs’ thinking about ideas and alternatives rather than about possible recommendations. Ms. Goss added that in the CIO Forum, the Subcommittee wants to talk with people who understand “what it takes for a business to implement” standards. The group returned to the matter of participants in the next session.

CIO Forum Planning― Mr. Coussoule and Ms. Goss (slides)

The purpose of this one- or two-day forum is to solicit input from a diverse set of end-users of standards and operating rules―primarily Chief Information Officers from several arenas (health plans, provider groups, intermediaries, clearinghouses, etc.). Mr. Coussoule noted that most of the people the Subcommittee has talked to so far are creators of the standards and operating rules, not users. Mr. Landen later added that the Subcommittee also wants to hear from those who have to “make the hard choices on what they invest in,” thus getting the perspectives of both decision-makers and implementers. The roadmap will be the major focus. Of the several questions that will be posed, Mr. Coussoule noted that an important question to focus on is – what changes in health care call for attention and might impact the roadmap?

He then asked for suggestions on how to structure the forum for best results – members offered their thoughts. The group also considered possible ways to broaden the perspectives represented by the forum participants, such as by including small providers (perhaps through their associations) or consumers/patients; however, most members favored keeping a narrow lens on CIOs’ perspectives. The idea of two separate, well-organized days was proposed. Invitees will also be asked for written testimony in advance, in response to a set of predetermined questions. Dr. Stead and Ms. Kloss suggested that these might focus on what big challenges they are facing, to help the forum itself focus on strategies and stay out of “the weeds.”

Ultimately, Mr. Coussoule indicated that the Subcommittee will incorporate the feedback from this forum into the roadmap and cycle draft recommendations back to the participants for vetting. The Committee briefly considered next steps, timing considerations, bandwidth, and staffing for this project. Finally, Mr. Coussoule thanked colleagues for their suggestions and briefly summarized the Subcommittee’s other planned projects.

New Medicare Card Project/MBI Follow-up―Dr. Stead, Full Committee

Dr. Stead reminded the group that NCVHS members had been asked to reach out to their constituencies to get a sense of whether the message about the new Medicare card was getting out, in order to share this feedback with CMS. CMS was represented at this meeting by Monica Kay from the Medicare Project Management Office and (by phone) Lois Serio. Following are brief summaries of the members’ reports and key concerns and the ensuing discussion:

  • Love on information from National Association of Health Data Organizations (NAHDO): The message about the new card and number is out, but there is uncertainty about the Social Security Number (SSN) and the continuity of data for research. They propose a meeting between NAHDO and CMS. Ms. Kay affirmed that the SSN will not go away, “especially for research purposes,” and she announced a CMS open door forum with states on January 23. Ms. Love alerted the CMS representatives to misinformation floating around the states about this subject.
  • Cohen suggested reaching out to state vital registry and vital statistics offices through the National Association for Public Health Statistics and Information Systems (NAPHSIS).
  • Mays commented that researchers who use SSNs and mortality data are very concerned, partly about potential costs. Ms. Kay stressed the distinction between the health insurance claim number and the SSN: the former, not the latter, will be replaced by the Medicare Beneficiary Identifier (MBI). Dr. Mays suggested reaching out to population centers and demography groups.
  • Landen’s informants thought it was a good idea to remove the SSN from the ID card.
  • Coussoule talked to health plan colleagues, whose chief concern is whether provider offices are prepared for the change. Ms. Serio described CMS’s efforts to prepare Medicare providers.
  • Goss said her state contacts shared the concern expressed by NAHDO representatives about ResDAC. Ms. Kay asked them to send her the specific question. Ms. Goss praised the CMS team’s educational session and interactions at a December WEDI meeting. There will be more such orientation and listening sessions.
  • Phillips (note: mis-identified as Dr. Cohen at this place in the transcript) thanked CMS for its outreach to the specialty societies, and reiterated Dr. Cohen’s question about the vitals community’s readiness for the change, if indeed they will be affected by it. Ms. Serio said a major objective of the transition is to allow current business processes using the SSN to continue.
  • Like Dr. Mays, Dr. Thorpe spoke to researchers who expressed concerns about costs.
  • Monson talked to large health care providers (at Sutter Health) who said they had not received the CMS letter, and they were surprised to learn of the change. She suggested there is a still a need for communication to providers. Ms. Serio said providers can go to the CMS website where they can order tear-off sheets and posters for their offices; Ms. Monson pointed out the need to let people know about that, and that letters have to go to the right person in the health care organization.
  • Strickland works with state Medicaid departments that are aware of the initiative.
  • Stead noted some people at Vanderbilt are aware of the change and are ensuring everything is flowing, but there is “a general lack of awareness at the upper levels of the institution.” He also expressed concern about what happens on April 1 when a new beneficiary walks in with a new card, specifically whether the front desk teams are prepared to handle it. Ms. Serio described CMS’s work with practice management vendors, the CMS 1-800 call center, and web portal tool, to help people during the transition. Dr. Stead praised the content on the website.

Foundations for Evidence-Based Policymaking Act of 2017 (HR 4174)

― Amanda Cash, HHS/ASPE (slides)

Ms. Cash described the context for this initiative as a “push from OMB” for the Executive Branch to focus on using available data to make the best possible decisions about programs and policies, and then to evaluate and learn from the results. She cited the book, “Moneyball for Government,” written by former OMB directors and others. She reviewed the creation of the Commission for Evidence-Based Policymaking (CEP) and its resulting report and 22 recommendations, released in September 2017. The biggest new recommendation, she said, is the National Secure Data Service (NSDS).

The House passed the Foundations for Evidence for Evidence-Based Policymaking Act of 2017 in mid-November, 2017. The Bipartisan Policy Center has received funding from the Arnold Foundation to have a person on staff to help implement the CEP recommendations – Nick Hart, former Deputy Director for the Commission. A pending Senate bill is similar to the House version but does not include the NSDS, perhaps because of its complexity, among other differences. The House bill outlines provisions in three areas: strengthening privacy protections, improving secure access to data, and enhancing government capacity. OMB will provide guidance to the federal government based on this bill―for example about mandated data inventories. The bill also calls for creation of an Advisory Committee on Data for Evidence-Building, which Ms. Cash said NCVHS might provide input into.

The CEP recommendations of particular relevance to NCVHS are #3 (Enhancing Privacy Protections for Federal Evidence Building) and #5 (Strengthening the Evidence-Building Capacity within the Federal Government). Ms. Cash suggested that NCVHS stay abreast of what is happening, noting that the Senate bill is on a slower track than the House bill. Asked about any pre-work for the Committee in the meantime, she suggested reading the report language, with special attention to Title 2. Ms. Bernstein called attention to a section that requires agencies to maintain a catalog and inventory of data sources, and suggested that NCVHS advise HHS on this, drawing on members’ familiarity with the Department’s data assets and with important uses of the data.

Dr. Mays expressed concern about researchers’ access to data if/when the data are part of the National Secure Data Service. Ms. Cash agreed with her that this would be useful for NCVHS to think about.

Summarizing, Dr. Stead observed the law still has to pass, and OMB will need to figure out how to deal with it across agencies; then HHS will respond to the OMB guidance. While Ms. Cash said the intent is to ensure that more people have more access to data for decision-making purposes, Ms. Bernstein observed that the bill would “change the way we deal with data in many ways and … could be quite burdensome to the Department.”

Next Generation Vital Statistics Hearing―Dr. Ross and Dr. Cohen (slides)

Dr. Ross began by summarizing the findings from the September NCVHS hearing on the Next Generation of Vitals. In short, times have changed, and the public and policymakers expect accurate, timely data. Vitals data play many key roles in many sectors. The national vital records operation is built around an antiquated, paper-based world, and the vital statistics system is at risk as a result of serious structural and resource challenges. The NCVHS vision statement for the vitals system developed for the recent hearing, envisions a sustainable, secure, and robust vital records infrastructure that meets the nation’s needs for timely and accurate information. The guiding question for the hearing was how to transform today’s vulnerable federated network into a network of systems that produces accurate and timely information supporting the full breadth of local, state, and federal data needs.

Continuing the presentation, Dr. Cohen said that soon after the hearing, NCVHS commissioned Gib Parrish, MD, to develop a report on the breadth of uses and users for vitals and on existing revenue sources. His research resulted in the report, “Vital Records and Vital Statistics in the United States: Uses, Users, Systems, and Sources of Revenue,” submitted to the Committee for approval. Dr. Cohen was the first of many to praise the report as an incredible accomplishment that will serve as a rich foundational resource for NCVHS and the wider community. After highlighting several tables in the report, he quoted Dr. Parrish’s conclusion that relatively little is still known about the functioning, funding, and long-term viability of vital records offices and vital statistics programs, along with his recommendation of a systematic effort to obtain additional information. Dr. Parrish, speaking by telephone, also pointed out the need to “make a plan for improving [the system] in the future.“ In the Committee’s discussion of the report, it was suggested that an explanation be added regarding where it fits in the broader body of NCVHS work on this topic. The Committee then passed a motion approving the report, with that addition.

Dr. Brett stated that the summary report of the hearing is still being drafted and will be circulated to hearing participants for their input before being finalized and returned to the full Committee for review. Dr. Cohen thanked Dr. Brett for organizing the hearing and recruiting those who testified, and Ms. Kanaan for drafting the summary report. In response to a later question, he said the report would mention the ideas suggested by hearing participants but would not include NCVHS recommendations.

Next Generation Vitals for 2018

Dr. Cohen then led a discussion of alternative approaches to further NCVHS work on the next generation of vitals, as summarized in a matrix showing the idea, design considerations, and intended outcomes for five alternatives. He also asked for any new ideas and consideration of the Committee’s bandwidth.

The group spent most of its time discussing the first alternative, namely, to 1) simplify and preserve the federated system for vital records by limiting vital records to the fact of birth and death and 2) strengthen public health surveillance at both state and federal levels by reporting additional data directly from electronic medical records to registries at both levels, with movement toward interoperability of data systems. The idea was put forward by Dr. Stead, who explained his thinking, citing the complexity of the information that must be included in the standard (2003) certificates of birth and death. Mr. Coussoule noted that key questions are who loses if this simplification takes place and whether the lost information is valuable. Another fundamental question is how to speed up transmission of the basic facts of birth and death to those who need them rapidly. The differences between information sourcing for birth and for death were noted, since most of the information on births can be gotten from/at the hospital.

After noting that during the process of researching his report for the Committee, it was especially difficult to get information on the financing of the system—and based on concerns around inadequate funding provided in testimony at the September hearing—Dr. Parrish shared the idea (item B in the matrix) to gather additional information, possibly through a NAPHSIS survey, to help understand the flows of money and data through the system. Dr. Ross noted that most of the ideas in the matrix tie back to the financial consequences, and he supported trying to get further knowledge about the costs and revenues and who pays.

Summarizing the foregoing discussion, Dr. Cohen noted two major themes for future exploration: how to expedite the transmission of essential information, and how to change the business model to make the system sustainable. Ms. Hines indicated another hearing is tentatively on the schedule for later in 2018, with recommendations to HHS to be developed after that.

HHS Data Access: Approach to Fact-Finding―Dr. Phillips (slides)

Dr. Phillips thanked Vickie Boothe of CDC, who joined by telephone for this session, and Ms. Hines for their help in organizing this presentation. He described the issues and history related to four CDC data systems that have become less easy to access at best and inaccessible at worst: Community Health Status Indicators (CHSI), shuttered in August 2017; HHS Health Indicators Warehouse (HIW), decommissioned in June 2016; Behavioral Risk Factor Surveillance System (BRFSS), which was supported and accessed through the HIW; and Health Data Interactive (HDI), closed in July 2016. (Refer to the slides for further details.) The questions for NCVHS include which data are no longer available reliably; which are now more difficult to access; which communities need these data, and for what purposes; and whether alternate sources for the data exist. Later, another question was added to the list concerning what other existing data sources are also at risk. The Subcommittee on Population Health is taking the lead on this NCVHS project. Its next step is to do fact-finding on these questions, after which it will decide what to do with the information and how NCVHS might respond.

During the discussion period, Dr. Mays, Dr. Thorpe, and Dr. Cohen volunteered to join the work group taking the lead on this project. In response to a question about its objectives, Dr. Phillips said a basic goal is to make the data available to the communities that have already demonstrated they will use them beneficially. Dr. Ross observed that the problem is that when government collects information in response to a demonstrated need for it, it typically does not also create a business plan for sustaining the resulting system; thus, “it needs to be a pretty powerful voice to say ‘we want this,’ or else it has to be commercialized.” Ms. Hines added that such information systems typically have no supporting legislation and no established office within government where such work is housed. Others cited the mission of the federal government and the recent CEP report and its sequelae as bases for defending and protecting such information sources. Dr. Coussoule wondered about disconnects between data creators and data users, including questions of value generation and recognition.

Ms. Love stated her sense that “the infrastructure is eroding.” Dr. Phillips indicated that the fact-finding process is intended to hear from the user community what other datasets may be in jeopardy.

―DAY TWO―

Introductory Remarks ―Dr. Stead

Dr. Stead explained that the first three briefings of the day are part of the NCVHS work on health terminologies and vocabularies.

UMLS Update and Discussion―Jerry Sheehan, Olivier Bodenreider, and Patrick McLaughlin, National Library of Medicine (slides)

Dr. Sheehan, Deputy Director of the National Library of Medicine (NLM), introduced this session. He explained that NLM is the central coordinating unit for HHS on health vocabularies and terminologies, adding that he has followed the work of NCVHS for many years. The Unified Medical Language System, or UMLS, began under the instigation of his predecessor, Betsy Humphreys, and Dr. Lindberg, the former NLM Director, to help computers talk to each other and understand the different medical languages being used and to provide a way to disseminate standards and terminologies as they developed. He introduced his colleagues, and noted that while the UMLS began as a long-term R&D project, it has since become operational and is continually updated. Dr. Bodenreider is with the cognitive sciences branch, and Mr. McLaughlin is in charge of NLM’s user services branch. Finally, Dr. Sheehan said that NLM hopes to complete its strategic plan in early 2018, with three major themes or pillars: standards development, stakeholder engagement, and human resource development. UMLS is a central part of its terminology services.

Dr. Bodenreider discussed the development of UMLS, starting in 1986, around the aforementioned goals. It records and collects the variety of ways in which medical concepts are expressed and combines them into a system. Dr. Stead stressed that while others tried to create a new, unified vocabulary, the UMLS is designed to show the relationships among all existing terms. Dr. Bodenreider added that NLM took the perspective of a library, collecting and interconnecting the elements to facilitate access and use. The UMLS is essentially a database with interfaces (APIs), accessed via a web browser. The UMLS Terminology Services provides controlled access for downloading files and deriving applications. It is “freely but not publicly available” because one needs to have a license to use it. It should be thought of as middleware.

There are three components: the UMLS Metathesaurus (all the concepts and relations from all the terminologies), the Semantic Network (semantic types and semantic network relationships), and lexical (text-processing) resources. It currently contains 153 source terminologies, not counting translations, including SNOMED, LOINC, ICD, and ICD-10-CM for the U.S. He gave an example using Addison’s Disease. As a library, NLM does not curate the sources; it simply reflects the content as it receives it. It organizes and integrates terminology, and also integrates the subdomains the terminologies are used for. Dr. Stead noted that this is an agile approach. The UMLS also integrates concepts and their interrelations. Dr. Bodenreider characterized the UMLS Metathesaurus as “a gigantic graph with point to point arrows and edges.” It does not curate the relations. Finally, the UMLS categorizes the concepts, which he illustrated using the concept “heart.”

Mr. McLaughlin then described the UMLS Terminology Services (UTS), the portal through which users interact with the data. It includes the Metathesaurus and SNOMED CT and is a distribution point for downloading products and services. The UTS is also used for licensing and user authentication for external and internal applications. Many external applications, including USHIK and AHRQ, use the authentication mechanism. NLM asks users to report on how they use the UMLS and the vocabularies within it, and produces an annual report on that basis. There are currently 26,000 licensees, 78 percent of whom are based in the U.S., but access to the Metathesaurus is across the globe. The preponderance of users (about a third) are academic institutions; other large categories are for-profit and not-for-profit organizations and government agencies. He shared a representative list of organizations and use cases (see slides). A major use case is using specific terminologies from the Metathesaurus; others include mapping between terminologies and doing research on terminology. As internal NLM uses, information can be retrieved in PubMed and MedGen, and consumer health information exchange is available through MedlinePlus Connect. He cited several additional examples of users and uses.

In response to feedback, NLM has reduced the number of releases of the UMLS and Metathesaurus to twice a year, in May and November. Mr. McLaughlin characterized the requests, over all, as “more more more, but simpler.” He added that NLM is also seeing growing concern about the “licensing burden.”

 

Discussion

NCVHS members talked with the presenters about support for licensees, capacity issues, users’ authentication issues, funding (which is solely through the NLM’s appropriation), and the nature of licensing (which is only for individuals). Dr. Stead expressed the Committee’s interest in ways to make the terminology development and dissemination process more agile. Ms. Roy reminded them that the U.S. edition of SNOMED CT and its content request system enables quick, agile maintenance of that classification, and Dr. Bodenreider cited Medical Subject Headings (MeSH) as another element of the agility.

ICD-11 Update and Discussion

―Donna Pickett, Chief, NCHS Classifications and Public Health Data Standards (slides)

In addition to serving as Chief of the NCHS Classifications and Public Health Data Standards staff, Ms. Pickett is head of the Collaborating Center for North America for the WHO Family of International Classifications (WHO-FIC). She noted that this was her third presentation to NCVHS about ICD-11 since 2016, and she reviewed the Committee’s active engagement in ICD, noting that a 1990 NCVHS report about the transition to ICD-10 highlighted many issues that still “painfully” exist.

There is a recognized need for ICD-11. Despite the updating process, ICD-10 is clinically outdated; structural changes were needed to some chapters; and there is increasing need to operate in an electronic environment and to capture more information for morbidity use cases. Thus the primary goals of the revision process and ICD-11 development are to ensure that it functions in an electronic environment, provides a multi-purpose and coherent classification, and provides an international multilingual reference standard for scientific comparability.

The U.S. is engaged in these revision and development activities. Dr. Christopher Chute of Johns Hopkins was chair of the revision steering group, among other roles, and Ms. Pickett co-chaired the Morbidity Topic Advisory Group (TAG). The TAGs were sunsetted in late 2016 and replaced by the Joint Task Force, on which she and Dr. Chute sit, as well as on the Medical and Scientific Advisory Committee, which replaces the present Update and Revision Committee. Ms. Kloss added that the U.S. has a completely distinct coordination and maintenance process for ICD-10-CM, which will go forward.

The design phase for ICD-11 took place from 2007-15; the second, consolidation phase, ends in 2018. The implementation phase will be 2018-2021, with release of the implementation version in June 2018, followed by regular maintenance starting in 2021. Ms. Pickett noted that different countries have different readiness for implementation, and they use the classification in different ways, some just for mortality statistics. WHO has planned robust field testing for ICD-11 to ensure continuity with ICD-10. She described the tools that have been developed, including browser and coding, proposal, translation, and mapping tools as well as informational materials and tools.

Returning to the 1990 NCVHS report, she identified questions and issues that warrant consideration as the U.S. considers ICD-11 implementation, such as about licensing; and she added that WHO would like to limit the development of national modifications. Ms. Auld of NLM noted that she and Ms. Pickett have talked about what the U.S. might do if it can’t have a clinical modification and whether the U.S. extension to SNOMED might help cover the gap.

Finally, Ms. Pickett showed the ICD-10 implementation timeline, which started with evaluation in 1994, suggesting that a similar 20-plus-year process for ICD-11 implementation would not be viable. She reiterated that NCVHS played an important role in the past in ICD transitions and commented on its potential role in the next one. Referencing the roadmap, Ms. Kloss observed that after the 2021 test period, the system should be stable, and “that might be the time for some evaluation.” Ms. Pickett concluded by outlining some ways the U.S. might approach the transition.

Speaking with reference to standards bodies, Ms. Goss asked Ms. Pickett’s view about whether the U.S. is “ready with the nuts and bolts for ICD-11,” and she responded that this question was discussed at X12 hearings in June. She added that she did not expect the structure to change very much; the question is how to “get all the trains in alignment so everyone reaches the endpoint at the same time.”

 Health Terminologies and Vocabularies Project: Next Steps

―Ms. Kloss, Vivian Auld (NLM), and Suzy Roy (NLM)

Ms. Kloss noted that the foregoing presentations completed the environmental scan process for this project, which the Committee launched in June 2017. She noted that one motivator for the project was to avoid going through the experience with the ICD-10 transition again. She asked the Committee to consider whether the stated goals for the project are the right ones―in short, to take a contemporary look at the landscape and its implications for timing in order to advise HHS on actions it might take to improve development, dissemination, maintenance, and adoption of standards for health terminologies and vocabularies.

Dr. Stead endorsed the goals as “still logical,” and predicted that the findings from the environmental scan would help the Committee decide where to place its emphasis. He commented on a “collision” he senses approaching between the “rapidly changing understanding of biology and our approach to figuring out how to measure useful population health statistics and a rapid change in our health reimbursement system that might decrease the need to codify some of these things.”

Ms. Kloss expressed gratitude that Ms. Auld and Ms. Roy from NLM will provide staff support for this project. Ms. Auld said the first milestone will be development of a report on the environmental scan by mid-2018. It will inform a roundtable meeting and possibly another hearing in 2018. The plan is to present a final report and letter to the Secretary to NCVHS for final approval in June 2019.

Dr. Cohen widened the discussion to include the population health perspective, urging the Committee to integrate and align its work on clinical vocabularies with its work on the indicators, language, and variables needed to understand community health. He and Ms. Auld talked about the social determinants of health frame of reference, which she said is “on NLM’s radar” because many in the wider NLM community are expressing interest in it. He suggested that the Committee think strategically about that development and integration. Dr. Sheehan remarked that “the ‘M’ in UMLS is largely an artifact of 1986 thinking,” prompting Dr. Phillips to support the idea of moving from “medicine” to “health.” Ms. Roy framed the goal as making sure that the UMLS encompasses all of it rather than having two parallel, unharmonized efforts. Dr. Sheehan added that NCVHS could be helpful to NLM by providing guidance on the priorities of different communities, different potential uses of the UMLS, and possible source vocabularies. Dr. Stead suggested that the NCVHS Measurement Framework for Community Health and Well-being could be curated as a terminology and handed to UMLS for incorporation.

Briefing: Fast Healthcare Interoperability Resources (FHIR)

―Paula Braun, Entrepreneur-in-Residence, NCHS (slides)

Ms. Braun is with the NCHS Division of Vital Statistics. The Entrepreneurs-in-Residence (EIR) Program, which is overseen by the HHS Chief Technology Officer, is a mechanism for bringing outside talent and fresh perspectives into the government. She was brought on to work on modernizing mortality data systems across the U.S., which she began by studying how the data flow into CDC and how the systems come together. She recognized the “deep dependence” on the work of state-level registrars, who work with very limited resources, and she saw an opportunity to think about how to integrate the process between data providers and end users of mortality data to make it more efficient and timely―an outcome that she said is applicable to other aspects of public health and health care information exchange.

Fast Healthcare Interoperability Resources (FHIR) is an open community, a standardized data model for exchanging health information, and a set of modern, Internet-based technologies. It was developed and exists within Health Level Seven (HL7) as a way to “get disconnected systems to act more like centralized systems.” It represents significant coalescence and synergistic work among broad stakeholder groups, both public and private.

Ms. Braun has used FHIR in the mortality space and connected people who know about it with public health partners. A focus has been how to give physicians who seldom complete death certificates a tool for accessing information when they need it. The idea is to make the tool and process bidirectional so the coded information goes back to health care providers to help them understand their patient populations. She worked with Michelle Williamson and Hetty Khan from NCHS on this project, and they are still working on developing a meaningful machine-learning algorithm to help physicians determine the sequence of events that led to death for a given patient. The project is called “Death Worm” because it crawls through records to produce real-time results. The goals are to map death certificate data elements to FHIR, develop a clinical decision support tool for death reporting, and enable various types of analytics. The tool is being tested at a connect-a-thon in Cleveland in January and in Utah, the project’s state partner. The EHR vendors Epic and Cerner have developed galleries to host these applications, and Ms. Braun and her team are working with graduate students of Dr. Mark Braunstein at Georgia Institute of Technology on further development, matching them with project mentors in “the real world.”

Ms. Braun concluded with comments on the importance in such endeavors of setting clear priorities, testing, providing tools that run automatically in the background, delivering value, and protecting privacy and security.

In follow-up discussion, Dr. Mays asked about ways to ensure data quality, e.g., regarding race and ethnicity; Dr. Cohen invited Ms. Braun to get involved in the Committee’s project on the next generation of vitals; and Dr. Stead noted the resonance of Ms. Braun’s presentation with many current NCVHS initiatives.

Health Data Landscape―Nancy Potok, Chief Statistician, OMB

In addition to being the Chief Statistician at OMB, Dr. Potok was a Commissioner on the Bipartisan Commission for Evidence-Based Policymaking. She said her remarks would focus on “where federal statistical data are headed,” broadly speaking, including the health and other programmatic data needed for evidence-based policymaking. She spoke of statistical activity under a broad umbrella, not just in terms of Designated Statistical Agencies, defining it as “data used at an aggregated level to inform policy or program evaluation or other things.”

Her job, which is laid out in the Paperwork Reduction Act, includes issuing standards, promulgating race and ethnicity standards, designating metropolitan statistical areas, and issuing statistical directives. She works with the Interagency Council on Statistical Policy, and represents the U.S. internationally. As a former CEP Commissioner, she was able to “go back to OMB and really light a fire” about implementing its recommendations. She noted that the House Bill discussed earlier in the meeting does not get into how to achieve the stated goals, but “the heart of the matter is access to data.” OMB has a Data Council that looks at such issues, and the new Deputy Director for Management, Margaret Weichert, has made data and data management a high priority.

OMB is putting together plans to build capacity for evidence-building in agencies, starting with the agency inventories of their data assets and moving toward an organized way of accessing them, with better coordination and overcoming of silos. “There are a lot of silos.” This will require cohesive policy in the agencies reflecting understanding of the value of the data they have and putting the data to use. This also requires better understanding of “what about the data makes them harder or easier” to access and use. The net result of these efforts will be the modernization of federal data collection and dissemination for the 21st century.

Dr. Potok pointed out that today, federal data are a small but critical piece of the universe of data―critical because of qualities including accuracy, regular release, and consistency that make federal statistical data the gold standard for quality. However, the world is moving beyond the point where it is possible to rely “solely on surveys and some censuses to collect federal data.” More data sources are available, albeit of “questionable quality”; and meeting users’ needs means looking at combining data from multiple sources. One significant potential source is administrative records, which are generally more complete than survey data and pertain to the entire population in question.

Noting the pockets of research, the tendency of agencies to “go off on their own,” and the lack of a directive or common vocabulary, she asked, “How do we move forward in a more uniform way?” She has been working for the past year with the Interagency Council on Statistical Policy to set priorities and develop standards and methods for federal agencies that work with combined statistical data, and also to consider various ways to go about achieving the goals and how to sustain the enterprise. One factor is that much of the data of interest are collected by the states and given to the federal government, and there is not always good quality control. There are pilot projects around the country, funded by foundations that suggest a promising approach to addressing this. Her aim is to encourage federal agencies to reach out and work productively with state and local partners on such efforts, to improve the quality and completeness of data for research and evidence building. The approach that provides the most incentives is for people to actually use the data, see the issues, and have data providers take steps to fix them. Therefore, encouraging joint activities is a priority.

The Federal Committee on Statistical Methodology, composed of career federal employees, has sponsored three workshops on data collection, processing, and dissemination. A February 2018 workshop will summarize what was learned, and the results will be presented at a large research conference in early March. Information about these workshops is on its website. OMB will issue a request for information on January 12 regarding research on areas related to the quality of combined data. Ultimately, a research agenda will be developed based on these inputs, to focus future research efforts in this area. The Committee on National Statistics (CNSTAT), which has been very engaged and helpful, convened a panel on issues in combining data from multiple sources, generating an interim report. Additionally, a lot of work has been done internationally. She concluded with reflections on the dimensions of quality.

In the brief discussion period, NCVHS members commented on the challenge of assessing the value of and gaps in federal data inventories, the question of whether tests of new data science approaches can be sponsored by the federal government, and the need to incentivize agencies to test new approaches that supplant the incentives embedded in the budgetary status quo. After stating that “The risk is in the status quo,” Dr. Potok expressed hope in partnerships with people outside the federal government to seed innovation.

NCVHS 2018 Review of Next Steps

The Committee briefly reviewed its immediate next steps. Ms. Hines noted that the Executive Subcommittee meets monthly to coordinate and move NCVHS projects along.

Public Comment

There being no public comment, Dr. Stead adjourned the meeting.

I hereby certify that, to the best of my knowledge, the foregoing summary of minutes is accurate and complete.

/s/                                                                           March 22, 2018

Chair                                                                                  Date