Department of Health and Human Services
NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS
May 27-28, 2015
Hubert Humphrey Building, Washington DC
MEETING MINUTES

The National Committee on Vital and Health Statistics was convened on May 27-28, 2015, at the Hubert Humphrey Building in Washington, DC. The meeting was open to the public. Present:

Committee members

Walter Suarez, MD, Chair
John J. Burke, MBA, MSPharm. (by phone)
Raj Chanderraj, MD, FACC
Bruce Cohen, Ph.D.
Llewellyn Cornelius, Ph.D.
Alexandra Goss
Linda Kloss, RHIA, CAE, FAHIMA
Denise Love
Vickie Mays, Ph.D., MSPH
Sallie Milam, J.D., CIPP/G (by phone)
David Ross, Sc.D. (by phone)
William W. Stead, M.D.
Ob Soonthornsima
James Walker, MD, FACP (by phone)
Absent:
Len Nichols, Ph.D. (retiring)

Lead Staff and Liaisons

James Scanlon, ASPE, Exec. Staff Director
Debbie Jackson, NCHS, Acting Exec. Secretary
Terri Deutsch, CMS
Maya Bernstein, ASPE

Others (not including presenters)

Katherine Jones, NCHS
Tammara Jean Paul, NCHS
Hetty Kahn, NCHS
Marietta Squire, NCHS
Suzie Beebe, ASPE
Leslie Francis, J.D., Ph.D., Data WG
Chris Fulcher, Ph.D., Data Working Group
Leah Vaughan, M.D., Data Working Group
Katie Hogan, VA
Shana Olshan, CMS
Steve Lazarus, CAQH Core
Afton Wagner, HIMSS
Kelly Turek, AHIP
William Alfano, BCBSA
Dan Rode, Dan Rode & Assoc.
Susan Kanaan, consultant writer

Note: The transcript of this meeting and speakers’ slides are posted at ncvhs.roseliassociates.com. (Transcripts are linked to the meeting calendar, and slides to the agenda.) NCVHS letters and reports, once approved, are also posted on the website.


 

EXECUTIVE SUMMARY

ACTIONS

The Committee unanimously approved a letter to the Secretary transmitting findings and recommendations on supporting community data engagement through increased alignment and coordination, technical assistance, and data stewardship education.


Introductory Remarks―Dr. Suarez

Dr. Suarez was welcomed and congratulated as the new Chair of the National Committee. He announced that Ms. Goss would replace him as Co-chair of the Subcommittee on Standards.

Updates from the Department

  • ASPE―Jim Scanlon

After noting that Mary Wakefield is the new Acting Deputy Secretary of Health, Mr. Scanlon reported on ACA health care reform and discussed the plans to measure its. The Data Council’s data strategy has two dimensions: alignment and integration; and improving the use of technology to collect, analyze, and make data available. The areas targeted for alignment are health insurance measurement, behavioral health, and vulnerable populations. HHS is also working to improve timeliness.

  • CMS―Shana Olshan and Elizabeth Holland

Ms. Holland gave an update on the Medicare and Medicaid EHR Incentive Program. Ms. Olshan then focused on ICD-10 implementation and CMS’s outreach, training, and testing activities to ensure a smooth transition. She stressed that “CMS is ready for ICD-10.”

  • OCR Health Information Privacy Update―Rachel Seeger

Ms. Seeger described several recent OCR activities including issuing guidance on HIPAA and workplace wellness programs, with a rulemaking by the EEOC, and an important settlement that sends a message to small health care providers and others about the need to protect patients’ records and dispose of them properly. She also described forthcoming OCR products.

  • HITECH Interoperability Roadmap―Erica Galvez

Ms. Galvez, ONC’s Interoperability Portfolio Manager, reported that a draft of the Roadmap was released at the end of January for public comment, and ONC is now updating it based on the 250 comments received. In general, the comments are supportive and ask for tweaks around the edges. She stressed that the roadmap is for health IT overall; it is meant to be nationwide in scope; and it frames interoperability as a support mechanism for achieving the Triple Aim. When completed, version 1.0 will go through HHS clearance, probably in June or July. The roadmap will be updated every two years.

NCVHS Strategic Planning Matrix and Process

Members reviewed a draft planning matrix presented as a starting point for an ongoing discussion within the Committee. After further development by the Executive Subcommittee, it will be used to coordinate planning and facilitate convergence across all the subcommittees and the Working Group and to help orient new NCVHS members. Mr. Scanlon offered thoughts about the Committee’s mission to contextualize the planning document. He also suggested developing criteria for deciding what projects to commit NCVHS resources and bandwidth to.

ACA Data Standards Review Committee―Mr. Soonthornsima (slides)

After reminding the Committee of the genesis, structure, and responsibilities of the ACA Data Standards Review Committee, Mr. Soonthornsima reviewed the plans for its forthcoming June 16-17 hearing. Its purpose is to frame and rationalize effective usage by focusing on four areas: value, barriers, opportunities, and changes. He gave a brief primer on the complex business environment for health care and the function of transaction standards within it. There is a lot of interest in presenting at the hearing. After the hearing, the written and oral testimony will be analyzed and a letter to the Secretary will be developed, with recommendations, for review and approval by the full Committee.

Overview of Population Health Letter to the Secretary―Dr. Cohen

Dr. Cohen presented a draft letter to the Secretary containing findings and recommendations on supporting community data engagement. The letter was developed by the Subcommittee on Population Health, based on findings from a series of workshops and roundtables. The recommendations are in the areas of alignment and coordination, technical assistance, and data stewardship education. Members suggested a few revisions. In day two, after further discussion, the Committee approved the revised letter.

NCVHS Framework Project―Dr. Stead (slides)

Dr. Stead explained that this is a project of the full Committee, facilitated by the Population Health Subcommittee, with workgroup members from all NCVHS subcommittees. Its purpose is to offer a systematic approach to thinking, talking, and acting with respect to data. The target audience includes statistical and analytic experts, researchers, data suppliers and intermediaries, and application developers. Through a white paper on the project, NCVHS seeks to engage interested colleagues in a collaborative effort to elaborate the Framework. It also hopes to stimulate and support an ongoing dialogue that develops resources for communities and other data users. NCVHS members endorsed the foregoing statement of purpose and goals.

Dr. Stead described changes in the latest version of the draft white paper and asked for comments on the project, the white paper, and the Framework itself. Members offered questions and comments about the business case, how to pilot use, and other matters. Following discussion, they agreed to ask the Data Working Group for feedback.

Subcommittee on Privacy, Confidentiality and Security―Ms. Kloss (slides)

Ms. Kloss reported on the status of the Toolkit for Communities Using Health Data, the public meeting on the Section 1179 HIPAA exemption for financial institutions, and the Subcommittee’s plans for the future. The toolkit will be released as a PDF with a request that people post it on their organizations’ websites and share it at meetings and events. The Subcommittee met its objectives for the public meeting on Section 1179: understanding the current and anticipated financial services practices involving personal health data; reviewing how Section 1179 is being interpreted and applied; and identifying what if anything NCVHS might recommend in this area. It plans to write a letter to the Secretary about its findings.

ONC Privacy and Security Update―Lucia Savage, ONC Chief Privacy Officer

Ms. Savage began by discussing the new “Guide to Privacy and Security of Electronic Health Information,” v 2.0, published on April 10. She then described ONC’s forthcoming projects. For an analysis for the White House on opportunities for learning presented by big health data and significant gaps in regulation, it received several hours of testimony that will be summarized in a report to be reviewed by the Policy Committee in July. In general, Ms. Savage said her office is figuring out what “great policy questions” need to be answered to protect privacy, grow the economy, and provide the health care system with good information.

Standards Subcommittee Activities and Deliverables―Mr. Soonthornsima and Ms. Goss

The co-Chairs showed a slide outlining the Subcommittee’s planned activities and deliverables through June 2016, and they commented on each of the areas of work. The Subcommittee is figuring out efficient ways to do everything required of it in addition to serving as the Standards Review Committee.

Public Comment

(See detailed summary.)

Subcommittee on Population Health Convening Activity―Drs. Cohen and Stead (slides)

Dr. Stead presented the Subcommittee’s thinking about a proposed convening activity focusing on a standard set of core metrics. He asked members for input and suggestions. Mr. Scanlon endorsed the idea of NCVHS serving as a convener for a critical look at how the IOM recommendations and the topic “fit into the ecosystem,” and where to take this next. Dr. Mays noted that there are differences of opinion about “whether these were the perfect set” and whether they adequately map onto all the populations of concern; further refinement may be needed so it is useful to public health as well as the health care system.

Members agreed to request a briefing on the report at the September meeting, with the convening activity held subsequently. The Subcommittee plans three conference calls over the summer to continue planning the convening activity, tentatively scheduled for November 17.

CMS RFI Announcement―Ms. Deutsch

Ms. Deutsch announced that as a result of NCVHS recommendations and comments from the health care industry, CMS on this day placed on display in the Federal Register a request for information on the current health plan identifier. It will be published on May 29, with a 60 day comment period.

E-Vitals Project Demonstration

  • Introduction and Overview―Delton Atkinson, NCHS (slides)

Mr. Atkinson, who directs the Division of Vital Statistics at NCHS, described several NCHS initiatives to improve the timeliness, quality, and usability of vital statistics data, and expanding their use for surveillance and health services research. All are aimed at automated collection of vitals.

  • eVitals Standards Initiative―Michelle Williamson, MS, RN, CPHIT, NCHS (slides)

Ms. Williamson and her NCHS colleagues have been working with the Division of Vital Statistics for several years to put in place national standards for system interoperability. The standards have been approved as drafts by HL7, and pilot projects have begun in several states for both birth and death. The goal of the initiative is to support the development of Vital Records standards to enable interoperable electronic data exchange among EHR systems, US vital records systems, and other public health information systems for birth, death, and fetal death events. A major focus is to capture information at the point of contact with the patient, using HL7 standards and ones provided from Integrating the Healthcare Enterprise (IHE). The standards are for messaging and documents. NCHS is supporting trial implementation testing at IHE Connectathons and in other ways. Trial and pilot implementation activities will make it possible to move the draft standards to final versions. NCHS is also doing outreach about the initiative and developing materials for broad dissemination. Major goals are to promote testing and get states involved.

Ms. Williamson introduced the presenters for demonstrations of the automated systems, using fictitious cases. (See the detailed summary and the transcript for details.)

  • eBirth Demo―John Stamm, Epic; Mike Gahagen, Genesis Systems
  • eDeath Demo―Jacob Tripp, Intermountain Health Care; Lisa Finch, Utah DOH; Jeffery Duncan, Utah DOH
  • Enhancing EHR Systems for Exchange with Electronic Vital Records Systems―Dan Friedman, Ph.D. (slides)

Dr. Friedman, a former NCVHS member, is a consultant (with R. Gibson Parrish, MD) to the Public Health Informatics Institute (PHII). Their NCHS/CDC-funded project involved developing a roadmap with possible routes for certification of electronic health record systems (EHRS) capability for generating and exchanging data with electronic vital record systems (EVRS). The broader purpose is to develop a roadmap for enhancing EHRS to generate and exchange data with EVRS. He described the findings from an environmental scan and extensive interviews about perceptions of barriers and facilitators to EHRS/EVRS integration and recommendations for next steps. On that basis, Drs. Friedman and Parrish created a detailed, 9-phase roadmap for enhancing EHRS to generate and exchange data with EVRS, from project concept and planning to evaluation and improvement. Finally, he outlined the criteria for choosing the specific routes for integration.

  • Discussion (all eVitals sessions)

NCVHS members had a number of detailed questions and comments about each of the demos, and there was discussion of many related issues throughout the presentations. Regarding when the systems will be fully operational and an inherent part of CDC state directives, Mr. Atkinson said this depends on finding the resources to make it happen. Members expressed strong support, and asked how NCVHS can help advance the eVitals Initiative. Ms. Williamson pointed to the need for funding to support more pilots, to generate the evidence to move this beyond hypothesis. The other big challenge is vendor engagement.

Briefing on the Working Group on Data Access and Use―Dr. Mays (slides)

Finally, Dr. Mays gave a brief update on the Working Group’s current activities and plans for the future, and the group discussed plans for NCVHS outreach at the Datapalooza and the National Conference on Health Statistics.


 

―DETAILED SUMMARY―

―Day One―

Welcome and Introductions

As the newly-appointed NCVHS Chair, Dr. Suarez thanked his colleagues for their support and commented on the challenges and opportunities the Committee faces. He welcomed Alex Goss as the new Co-Chair of the Subcommittee on Standards. The day was filled with congratulatory remarks to Dr. Suarez about his new role.

Updates from the Department

  • ASPE―Jim Scanlon

After reporting that Mary Wakefield is the new Acting Deputy Secretary of Health, Mr. Scanlon reviewed the HHS strategic plan for 2014-18. Plans in specific areas such as antibiotic resistance and delivery system reform cascade from the overarching plan, and each plan has measurable objectives. Congress is working on the FY16 budget, which begins on October 1.

On ACA health care reform, he discussed the “three-legged” plans to measure its impact, using EHR data; population, employer and provider surveys; and administrative data. HHS publishes ACA enrollment data as soon as they are available, and has enhanced surveys to monitor its implementation and impact. As previously reported, an NCHS research data center has been established at ASPE, which other federal agencies are allowed to use. The Data Council’s data strategy has two dimensions: alignment and integration; and improving the use of technology to collect, analyze, and make data available. HHS is working to improve timeliness, motivated in part by the ACA. The areas targeted for alignment are health insurance measurement, behavioral health, and vulnerable populations. ASPE is also studying approaches to the declining rate of survey responses.

NCVHS members had questions and comments about whether mental health will be included in surveys, in keeping with integrated care; sub-population details in mental health data; new standards for submitting health survey results from EHRs into public health agencies; and a request for a briefing on the status of health care reform (slated for the September meeting).

  • CMS―Shana Olshan and Elizabeth Holland

Ms. Holland began with an update on the Medicare and Medicaid EHR Incentive Program, covering the amount of incentive payments to date and the extensive work on several proposed rules and the Medicare Access and CHIP Reauthorization Act of 2015. Asked about the future of Meaningful Use after stage III, she said the third stage is sustainable and subject to constant updating. She was also asked about the plans for public health reporting in stage III.

Ms. Olshan focused on ICD-10 implementation and CMS’s outreach, training, and testing activities designed to ensure a smooth transition. Besides providing free educational resources, CMS is offering three rounds of external testing for Medicare providers, related to both acknowledgments and end-to-end testing, with the goal of having 2,250 testers participate in the latter. In sum, she declared that “CMS is ready for ICD-10.”

CMS has delayed enforcement of the Health Plan Identifier, and will soon issue a document to gather information from the industry about the use of the HIPD. (See statement later in meeting.) The next steps for certification of compliance are connected to the HIPD review. Ms. Olshan expressed the agency’s support for the designation of NCVHS/Subcommittee on Standards as the ACA review committee, predicting that it will help achieve the goal of ensuring that adopted standards solve a problem and provide administrative simplification for the health care industry.

NCVHS members expressed excitement about the implementation of ICD-10 and asked a few questions about details of the transition.

  • OCR Health Information Privacy Update―Rachel Seeger

In April, OCR issued guidance on HIPAA and workplace wellness programs, concurrently with a rulemaking by the EEOC. OCR has been working to increase awareness of the new guidance. It also had an important settlement in April, which Ms. Seeger said sends a message to small health care providers, including pharmacies, home health, occupational and physical therapists, and others about the need to protect patients’ records and dispose of them properly. OCR recently held a Google Hangout to interact with app developers about HIPAA, and it will do a similar forum at the Datapalooza.

Forthcoming products and services include the final rule for the National Crime Index Survey (now at OMB), an NPRM on monetary settlements for individuals who have been harmed by a HIPAA offense, guidance on HIPAA and the media, and a portal where stakeholders can request guidance from OCR on specific areas.

NCVHS members had follow-up questions in the aforementioned areas, and Ms. Seeger welcomed Ms. Kloss’ offer of the Committee’s help in exploring and clarifying minimum necessary and the intent of the rule.

  • HITECH Interoperability Roadmap―Erica Galvez

Ms. Galvez is ONC’s Interoperability Portfolio Manager and is responsible for “ushering the roadmap.” A draft was released at the end of January for public comment, and ONC is now updating it based on the 250 comments received (including comments from NCVHS member Sallie Milam, who summarized the substantive ones following Ms. Galvez’ presentation). All are posted on HealthIT.gov. In general, the comments are supportive of the roadmap and ask for tweaks around the edges. Several called for a unique health identifier. Some called for negative as well as positive testing, to see how the system performs when something goes wrong. Many stressed the importance of education. There are mixed comments on governance and rules of engagement.  

As key messages, she stressed that the roadmap is not just for ONC or HHS but for health IT overall; that it is meant to be nationwide in scope; and that interoperability is framed as a support mechanism for achieving the Triple Aim. The goal is to have information follow people and support decision-making. In the first three years, the focus is on clinical information; the next version will get more into the intersection with administrative data and integration of the two. Privacy and security, the business and regulatory environment, and governance are important areas where there are “opportunities for improvement” to advance interoperability. The roadmap includes plans to track progress and measure success. When completed, version 1.0 will go through HHS clearance, probably in June or July. The roadmap will be updated every two years.

NCVHS members noted the ongoing convergence of clinical and administrative data systems and data processing, and the Committee’s desire for close collaboration with ONC around the roadmap as the process goes forward. Ms. Galvez then gave a brief update about the plans for restructuring the ONC FACAs and workgroups to make them more nimble and effective.

NCVHS Strategic Planning Matrix and Process

The Committee reviewed a draft planning matrix presented as a starting point for an ongoing discussion within the Committee. Dr. Suarez gave an overview of the matrix and the thinking behind it. It will be used to coordinate planning and facilitate convergence across all the subcommittees and the Working Group, and also to help orient the new group of NCVHS members expected in the Fall. He suggested these cross-cutting principles for NCVHS work: transparency, value, equity, and trust.

Ms. Goss, who developed the matrix with Ms. Deutsch and Dr. Stead, noted that NCVHS planning needs to take into account the interoperability roadmap and other HHS plans. The NCVHS plan is intended to cover the projects and work products in every NCVHS domain, and it will be developed by the Executive Subcommittee. One purpose is to identify the Committee’s resource needs (staff, time, etc.) and help it manage its band width. The hope is that it will become “a living, breathing tool.”

The group discussed the conceptual framework, the need to identify target audiences for each area of endeavor, the changing landscape for the Committee’s work, and the realities of its limited bandwidth.

Mr. Scanlon observed that the primary goal and purpose of NCVHS is to advise the Secretary and HHS leadership. NCVHS is a data and statistical policy committee whose purpose is to improve information for decision-making with the goal of improving the health of the population through better health care quality, efficiency, access, trust, equity, and so on. Everything NCVHS does indirectly helps to support the ecosystem. Through the Secretary, other stakeholders such as states, communities, and providers may benefit from the Committee’s recommendations. He suggested incorporating a version of these goals into an NCVHS mission statement. Members liked the idea of prefacing the planning document with the mission statement. Mr. Scanlon also suggested developing a decision tree with criteria for deciding what projects to commit resources and bandwidth to.

As modifications to the planning matrix, members suggested adding a list of mandated NCVHS responsibilities and deliverables (which Ms. Jackson said she would provide), and possibly references to potential audiences. The developers of the original matrix will incorporate the new inputs and feedback. The Executive Subcommittee will continue to work on the planning document at its August planning retreat, with the intention of sharing it with new members in September. Ms. Kloss urged that new members be given a thorough orientation and if possible be brought in a half-day early for this purpose. The group agreed to revisit the Subcommittee structure as part of the planning process, although the importance of continuity vis a vis external constituencies was noted.

ACA Data Standards Review Committee―Mr. Soonthornsima (slides)

After reminding the Committee of the genesis, structure, and responsibilities of the ACA Data Standards Review Committee, Mr. Soonthornsima reviewed plans for its forthcoming June 16-17 hearing. He explained that unlike the Subcommittee on Standards, which focuses on evolving standards, the Review Committee is interested in adopted standards and their function in today’s business environment. Its purpose is to frame and rationalize effective usage by focusing on four areas: value, barriers, opportunities, and changes. He gave a brief primer on the complex business environment for health care and the function of transaction standards within it for various actions including pre-authorization and billing. This covers both enrollment and clinical data, ultimately enabling population-level analytics.

The hearing will focus on transactions―each of which, Dr. Suarez pointed out, has many components including standards, code sets, identifiers, and operating rules. Ms. Deutsch, lead staff to the Subcommittee, said there is a lot of interest in presenting at the hearing. NCVHS members discussed plans for the day. There was an appeal for video streaming to enable greater access. Ms. Goss said that after the hearing, the written and oral testimony will be analyzed and a letter to the Secretary will be developed, with recommendations, for review and approval by the full Committee. To prepare for the hearing and their role in it, a conference call will be held to brief members who are less familiar with the standards arena. Ms. Kloss noted that the hearing presents an opportunity for NCVHS to help people see the bigger picture of standards and their function in advancing administrative simplification.

Overview of Population Health Letter to the Secretary―Dr. Cohen

Dr. Cohen presented a draft letter to the Secretary containing findings and recommendations on supporting community data engagement. The letter was developed by the Subcommittee on Population Health, based on findings from a series of workshops and roundtables. Its 13 recommendations pertain to alignment and coordination, technical assistance, and data stewardship education. Dr. Cohen described each set and invited comments, prompting discussion and a few modifications to the letter. Dr. Stead said it is meant to be the first of more than one letter. The Subcommittee will bring a revised version of the letter to the meeting on day two for approval.

NCVHS Framework Project―Dr. Stead (slides)

Dr. Stead explained that this is a project of the full Committee, facilitated by the Population Health Subcommittee, with workgroup members from all NCVHS subcommittees. Its purpose is to offer a systematic approach to thinking, talking, and acting with respect to data by providing data and method classification resources, generating recommendations for the data supplier ecosystem (including Federal government) on high-impact gaps, and catalyzing development of interactive tools. The target audience includes statistical and analytic experts, researchers, data suppliers and intermediaries, and application developers. Through a white paper on the project, NCVHS seeks to engage interested colleagues in a collaborative effort to elaborate the Framework. It also hopes to stimulate and support an ongoing dialogue that develops resources for communities and other data users. NCVHS members endorsed the foregoing statement of purpose and goals.

Dr. Stead described changes in the latest version of the draft white paper and asked for comments on the project, the white paper, and the Framework itself. Ms. Kloss explained the thinking behind the new data stewardship component of the Framework. Ms. Love asked about the business case―who would use the Framework, how, and with what benefit. Dr. Stead explained that the idea is for original datasets to be tagged with relevant aspects of the metadata outlined in the Framework (at whatever level of specificity is known), thereby creating a harmonized and standardized set of metadata across data sources. Ms. Goss suggested that once the Framework is further fleshed out, there be outreach to get people to take the framework and create data commonality of this kind.

This led to a discussion of how to pilot use. Dr. Stead likened the current version to the early developmental stages of the Unified Medical Language System (around 1985). Dr. Suarez suggested developing a simplified guideline on how to use the Framework. A next step, according to Dr. Stead, could be to try to pilot the Framework in a “dry lab mode” to determine if this is a viable idea and a useful taxonomy; and he outlined six steps for such a pilot (see transcript for details). Ultimately, the resulting product would be used to work through an example, which would then make it possible to write the manual suggested by Dr. Suarez.

Dr. Suarez reiterated the need to test the model. Mr. Scanlon observed that NCVHS is “not an operational arm,” and sponsoring tests is beyond its mandate; however, it could ask for comment in appropriate forums. Dr. Stead expressed a desire to “do a tabletop” before it is put out for comment. Returning to the purpose for the project and tool, Ms. Kloss reminded colleagues that the project was initiated because of the absence of a common framework for making decisions. She wondered if the project could be carried on in an academic institution. Dr. Mays suggested exploring whether Damon Davis and his HHS data colleagues have interest in this potential resource. She also offered to organize a conference call with the Health Data Working Group to get their feedback, an idea that Mr. Scanlon endorsed. He suggested seeing what kind of data dictionary is currently used by HHS for tagging, and what GSA requires.

Subcommittee on Privacy, Confidentiality and Security―Ms. Kloss (slides)

Ms. Kloss reported on the status of the data stewardship Toolkit for Communities Using Health Data, the public meeting on the Section 1179 HIPAA exemption for financial institutions, and the Subcommittee’s plans for the future. Progress is being made on the toolkit, with work under way on the appendices. Although there are hopes ultimately for an interactive resource, it will initially be released as a PDF via NCVHS.gov delivery service, with a request that people post it on their organizations’ websites and share it at meetings and events. It will be publicized at the Datapalooza and the National Conference on Health Statistics. Dr. Suarez announced that he will give an overview of NCVHS and its products at the Datapalooza Data Lab.

The Subcommittee met its objectives for the public meeting on Section 1179: understanding the current and anticipated financial services practices involving personal health data; reviewing how Section 1179 is being interpreted and applied; and identifying what if anything NCVHS might recommend in this area. Ms. Kloss briefed NCVHS members on the meeting and the provision, noting that NCVHS made recommendations about it in 2004. She described the relevant environment and the significant changes in it since HIPAA was written and since 2004, partly as a result of HITECH. The definition of “business associate” proved to be a key focus of learning for the Subcommittee, and she described the other major things it learned and gaps that it identified. Dr. Francis stressed that “banks really want some help with this; … they want clarification” (though not more regulation). The Subcommittee concluded that the health care and financial industries each have things they can learn from the other. Finally, it identified related issues in the changing environment such as wearables, mobile apps for health and banking, and the expansion of Big Data analytics.

Among its next steps, the Subcommittee wants to hear from the Data Working Group about the evolving world , to dig into the use of predictive analytics in the financial services industry, and to follow up on the privacy functions in a large bank. However, it believes it already has enough information to write a productive letter to the Secretary. Among its anticipated recommendations is that there should be a health financial cross-industry work group that shares best practices and policies and looks for ways to advance privacy and the role of consumers. Another is that several entities need business associate agreement guidance.

Ms. Kloss then outlined the possible new projects being considered by the Subcommittee.

ONC Privacy and Security Update―Lucia Savage, ONC Chief Privacy Officer

Ms. Savage began by discussing the new ONC “Guide to Privacy and Security of Electronic Health Information,” v 2.0, published on April 10. It was last published in 2001, and she noted the many changes since then including the Omnibus Rule and secure messaging between patients and physicians. There was an effort to use clear, practical language and examples. She described ONC’s forthcoming projects to clarify rules for the health care industry and improve cybersecurity response and infrastructure for the health care sector. ONC also is doing an analysis for the White House on opportunities for learning presented by big health data, and significant gaps in regulation. For this, it received several hours of testimony that will be summarized in a report to be reviewed by the Policy Committee in July.

ONC has published findings from a hearing on mobile health held in 2012 and is working with the FTC to create a tool to help developers identify relevant regulations, to be released sometime in 2015. It is also looking at what is required of Fitbit as a covered entity. Over all, Ms. Savage said, her office is figuring out what “great policy questions” need to be answered to protect privacy, grow the economy, and provide the health care system with good information.

NCVHS members had questions and comments about data standardization and metadata for mobile devices, the status of work toward “computable consent,” and researchers’ pressing need for guidance on what to put in consent forms for research that involves wearables. Mr. Scanlon said “very smart folks” are working on revising the Common Rule, and there will be opportunities to comment on the proposed rule.

Standards Subcommittee Activities and Deliverables―Mr. Soonthornsima and Ms. Goss

The co-Chairs shared a slide showing the Subcommittee’s planned activities and deliverables through June 2016, and commented on each of the areas of work. (See the penultimate slide in the slide deck on the Review Committee.) The Subcommittee is figuring out efficient ways to do everything required of it in addition to serving as the Standards Review Committee. Mr. Soonthornsima said it looks forward to integrating new members. Dr. Suarez suggested adding transparency and virtual credit cards to the list of topic that need attention.

Members briefly discussed the history of NCVHS annual reports and other historical documents. Ever since the Committee’s 60th anniversary and the history published then, an expanded version of the HIPAA report to Congress has served as the vehicle for reporting on NCVHS activities and accomplishments.

Public Comment

Steve Lazarus of Boundary Information Group congratulated the Subcommittee on Privacy, Confidentiality and Security on “getting it right” with the banking industry and financial services. He described his organization’s work and perspectives in this area.

Dan Rode, a consultant and educator, noted the Committee’s “ability to look forward” and urged it to consider an ongoing environmental scan that looks at the process now in use regarding HIPAA standards and the barriers and advantages of continuing to do business in the same way. In addition, he called attention to bills now in Congress on cybersecurity as well as the White House’s approach to this topic, in terms of their potential impact on the health care industry.


 

―Day Two―

Subcommittee on Population Health Convening Activity―Drs. Cohen and Stead (slides)

Dr. Stead presented the Subcommittee’s thinking about a proposed convening activity, tentatively in the Fall, that would focus on a standard set of core metrics. The idea emerged as a priority choice among potential next steps identified at the Roundtable on Community Data Engagement. The activity could build on a recent IOM report, Vital Signs, for which Drs. Green and Tang served on the authoring IOM Committee.

Dr. Stead asked members for input on the recommended target audience(s) and participants, the approach to the IOM recommendations, and the domains or core measures on which to focus. He reviewed the IOM Committee’s recommendations for various actors and sectors. In response to a question, he said he sees the IOM report as a “fact base” and set of recommendations that provide a foundation for the NCVHS activity, adding that this is a subject for Committee discussion. One possible NCVHS approach is to look at core measures from the local-community perspective. Dr. Cohen added that NCVHS could recommend to the federal government how, or whether, to implement the recommended indicators.

The idea generated extensive discussion. Mr. Scanlon said he liked the direction conceptually, observing that this is “a classic population health issue.” The Committee’s role, he suggested, would be as a convener for a critical look at how the recommendations and topic “fit into the ecosystem” and where to take this next. Dr. Mays noted that there are differences of opinion about “whether these were the perfect set” and whether they adequately map onto all the populations of concern; further refinement may be needed so it is useful to public health as well as the health care system. Mr. Scanlon suggested including in an NCVHS convening data producers, Healthy People, CDC’s community assessment people, and the public health community, to round out the health care perspective. He agreed with Dr. Cohen that relevant work is also taking place in data organizations and intermediaries outside the federal government, and added to the list Census, the American Public Data Users Association, and people who have already done work in this area.

Members agreed that a briefing on the report at the September meeting would be helpful, with the convening activity held subsequently. Dr. Stead said the Subcommittee plans three conference calls over the summer to continue the planning. The convening activity is tentatively scheduled for November 17 prior to the November NCVHS meeting. He noted that the topic ties back to the issue of public health standards. Dr. Walker suggested looking for estimates that could help identify measures with the highest benefit-cost ratios.

Action on Community Engagement Letter―Dr. Cohen

Dr. Cohen presented a revised version of the letter to the Secretary discussed on day one, describing the revisions. After further discussion and minor additional modifications, members passed a motion approving the letter as revised. Dr. Suarez and others expressed appreciation for the clarity of the letter.

CMS RFI Announcement―Ms. Deutsch

Ms. Deutsch announced that as a result of NCVHS recommendations and comments from the health care industry, CMS on this day placed on display in the Federal Register a request for information on the current health plan identifier. It will be published on May 29, with a 60 day comment period.

E-Vitals Project Demonstration

Dr. Cohen introduced this presentation by stating, “It’s time to put the ‘V’ back in ‘NCVHS.’ He welcomed the presenters.

·         Introduction and Overview―Delton Atkinson, NCHS (slides)

Mr. Atkinson directs the Division of Vital Statistics at NCHS. The Division has been working to improve the timeliness, quality, and usability of vital statistics data, and expanding their use for surveillance and health services research. It has undertaken several initiatives in recent years, including enhancing a comprehensive network of state-based electronic death registration system and putting in place electronic birth registration systems, all aimed at automated collection of vitals. An HHS Entrepreneur in Residence is now helping to rethink how eVitals can provide a “central element” for future information collection. Recent funding has enabled NCHS to work with states to improve the quality of cause of death reporting, using the Validation and Interactive Edit Web Service (VIEWS). Another key activity is standardizing electronic information-sharing, toward the goal of minimizing the number of manual interventions it takes to process a record of a death. There has been marked progress toward this goal, along with improvements in timeliness and data accuracy.

  • eVitals Standards Initiative―Michelle Williamson, MS, RN, CPHIT, NCHS (slides)

Ms. Williamson and her NCHS colleagues have been working with the Division of Vital Statistics for several years to put in place national standards for system interoperability. The standards have been approved as drafts by HL7, and pilot projects have begun in several states for both birth and death. The goal of the initiative is to support the development of Vital Records (VR) standards to enable interoperable electronic data exchange among EHR systems, US vital records systems, and potentially other public health information systems for birth, death, and fetal death events. A major focus is to capture information at the point of contact with the patient, using HL7 standards and ones provided from Integrating the Healthcare Enterprise (IHE), working with both groups. The standards are for messaging and documents. (See slides and transcript for details.)

Ms. Williamson described the content of the work and some of the challenges involved. She stressed that because “a standard is only as good as the testing shows that it is,” NCHS is supporting trial implementation testing at IHE Connectathons and in other ways. Trial and pilot implementation activities will make it possible to move the draft standards to final versions. NCHS has some pilot tests under way and it is looking for funding for further testing.

Related projects include work to accommodate different state approaches and standards harmonization to support interoperability, in collaboration with SDOs and state partners. NCHS is also doing outreach about the initiative to various stakeholders and developing materials for broad dissemination. Major goals are to promote testing and get states involved. Ms. Williamson described a “paradigm shift”: the states are now receptive to eVitals and are asking for demonstrations. NCHS also collaborated with others to develop a draft template for a project management plan for implementing VR standards.

With that, Ms. Williamson introduced the presenters for demonstrations of the automated systems, using fictitious cases. (See the transcript for details.)

  • eBirth Demo―John Stamm, Epic; Mike Gahagen, Genesis Systems

The demo showed the submission of a range of birth and prenatal information from a hospital’s Epic EHR to a state health department using a standardized state form. Once the information has been verified and state requirements met, the information is sent to a Genesis system that collects the information and sends it to various state and national stakeholders. Mr. Gahagen stressed “the efficiency that can be achieved by an interoperability protocol.”

  • eDeath Demo―Jacob Tripp, Intermountain Health Care; Lisa Finch, Utah DOH; Jeffery Duncan, Utah DOH

This demo showed the transmission of clinical and cause-of-death information from the Intermountain Health Care physician/EMR and additional death certificate information from the funeral director to the Utah Department of Health using an HL7 standard and Utah’s electronic death registration system. Mr. Tripp said the Intermountain Health project has been under way since 2009 and was rolled out to all providers on an optional basis in 2013. The draft standard was implemented in 2014. The merge process between the two sources takes about 20 minutes when the information is complete (which at this point is about half the time, generally because of inconsistencies in the name). Mr. Duncan said Utah’s electronic system has been operational for transmitting death information since 2009. The use of this system has cut the time it takes to complete the death certificate roughly in half, or better.

In response to a question, he said the system could be expanded to include geocoding information―something Mr. Atkinson said NCHS has been talking about. Members mused about many other possibilities and expansions, as well. Mr. Atkinson affirmed that the vital statistics landscape is changing, albeit slowly. He added that funding is “one of the bigger barriers.”

  • Enhancing EHR Systems for Exchange with Electronic Vital Records Systems―Dan Friedman, Ph.D. (slides)

Dr. Friedman, a former NCVHS member, is a consultant to the Public Health Informatics Institute (PHII). His NCHS/CDC-funded project involved developing a roadmap with possible routes for certification of electronic health record systems (EHRS) capability for generating and exchanging data with electronic vital record systems (EVRS). The broader purpose is to develop a roadmap for enhancing EHRS to generate and exchange data with EVRS.

He and R. Gibson Parrish, MD, did an environmental scan and conducted interviews about perceptions of barriers and facilitators to EHRS/EVRS integration and recommendations for next steps. The consistent message was that the major goal is to improve the timeliness, accuracy, and completeness of vital records, and to do that as efficiently and economically as possible. Many respondents wanted to see the evidence for the hypothesis that EHRS/EVRS integration will accomplish this; and EHRS vendors wanted to know where the market is, noting the need for incentives for development and implementation.

Dr. Friedman said the respondents also identified a facilitator for almost every barrier, including long-term planning, stakeholder engagement, and national and state policies including mandates and incentives. Clinicians wanted vitals and EHRs-EVRS to meet their clinical needs and support quality improvement and patient safety. All sources stressed the need for planned pilot projects with common metrics.

Drs. Friedman and Parrish created a detailed, 9-phase roadmap for enhancing EHRS to generate and exchange data with EVRS, from project concept and planning to evaluation and improvement. (See slides.) He stressed the importance of engaging stakeholders, determining their needs, describing the workflow and state variations, assessing performance, and analyzing requirements. He noted that there are multiple possible routes within the roadmap; the slides illustrate “exemplars.” The routes vary along a set of common conditions such as place of data entry, type of data entry, place of data storage, and means of data transfer. He then outlined the criteria for choosing the specific routes for integration, including maximizing timeliness, accuracy, and economy; maximizing the likelihood of state health department acceptance; and maximizing the value proposition for all the stakeholders.

Discussion

NCVHS members had a number of detailed questions and comments about each of the demos, and there was discussion of many related issues throughout the presentations. One theme concerned the best way to collect and transmit valid information about race and ethnicity. Members also noted the practical and operational gaps that must be filled for these systems to realize their full potential.

On when the systems will be fully operational and an inherent part of CDC state directives, Mr. Atkinson said this depends on finding the resources to make it happen. Ms. Williamson predicted that there would be another year of having a draft standard. She added that providers have to be convinced to make the initial investment in the EHR systems that enable the “downstream flow”; and more vendors need to become engaged in testing. Dr. Cohen observed that there are 57 vital statistics jurisdictions with their own rules and requirements, so there are many moving parts and political variables to be juggled; even so, cultures are changing in state vital statistics. Ms. Goss noted the importance of federal agencies and standards groups aligning incentives to push the process forward.

The presenters were asked whether the states feel the need for change and are enthusiastic about these possibilities, and Mr. Atkinson said he is seeing enthusiasm and interest in the opportunities to improve state infrastructures. Ms. Williamson added that states are also asking NCHS for more information about the standards. Asked about how the work fits into the Interoperability Roadmap, she said NCHS has asked that the standards be recognized and included as part of the roadmap.

Members expressed strong support, and asked how NCVHS can help advance the eVitals Initiative. Ms. Williamson again pointed to the need for funding to support more pilots, to generate the evidence to move this beyond hypothesis. The other big challenge is vendor engagement. Coordination with the National Governors Association and the National State Legislators Group were suggested. In conclusion, Dr. Ross praised the NCHS team for their “methodical and smart” management of this project and the rate of improvement in electronic death registration.

Briefing on the Working Group on Data Access and Use―Dr. Mays (slides)

Dr. Mays said the Working Group’s products include advising, guidance principles for data access and use, and a potential article on the latter. It will be working to align its skills and assets to optimally serve its customer base, including HHS (notably the IDEA Lab) and NCVHS subcommittees. It has experimented with talking with a specific HHS data set, the National Health Interview Survey, with the idea of providing guidance on data access, but it hasn’t figured out yet how to give them feedback. Mr. Scanlon added that HHS will ask the Working Group to give “reactor advice” on some HHS websites and other datasets.

Dr. Mays said that the Working Group later today will talk with representatives of each NCVHS Subcommittee about how the Working Group can support their work plans. It has already started work on a distribution plan for the NCVHS Toolkit for Communities Using Health Data.

The discussion then turned to plans for NCVHS outreach at the Datapalooza and, later in the summer, the National Conference on Health Statistics.

After a brief discussion of ways to strengthen the relationship and communication with the Data Council, Dr. Suarez adjourned the meeting.


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

/s/ September 16, 2015
Chair Date