Department of Health and Human Services
NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS
November 18-19, 2015
National Center for Health Statistics, Hyattsville, MD
MEETING MINUTES
The National Committee on Vital and Health Statistics was convened on November 18-19, 2015, at the National Center for Health Statistics in Hyattsville, MD. The meeting was open to the public.
Present:
Committee members
Walter Suarez, M.D., Chair
Raj Chanderraj, M.D., FACC (by phone)
Bruce Cohen, Ph.D.
Nicholas Coussoule
Llewellyn Cornelius, Ph.D. (by phone)
Alexandra Goss
Linda Kloss, M.A., RHIA,
Richard Landen, MPH, MBA
Denise Love
Vickie Mays, Ph.D., MSPH
Sallie Milam, J.D., CIPP/G (by phone)
Michael O’Grady, Ph.D.
Robert Phillips, M.D., MSPH
Helga Rippen, M.D., Ph.D.
W. Ob Soonthornsima (by phone)
William W. Stead, M.D.
Absent:
Barbara Evans, Ph.D., J.D.
David Ross, Sc.D.
Lead Staff and Liaisons
James Scanlon, ASPE, Exec. Staff Director
Terri Deutsch, CMS
Others (not including presenters):
Debbie Jackson, NCHS
Katherine Jones, NCHS
Marietta Squires, NCHS
Susan Queen, NCHS
Suzie Burke-Bebee, ASPE (phone)
Vickie Booth, CDC
Katie Hogan, VA
Ruthann Phelps, VA
Kelly Turek, AHIP
Michael DeCarlo, BC/BS
Bill Alfano, BC/BS
Susan Kanaan, consultant
EXECUTIVE SUMMARY
Welcome and Introductions
Dr. Suarez applauded the fact that the Committee has its full complement of 18 members for the first time in several years, and welcomed five new NCVHS members to the meeting: Nicholas Coussoule, Richard Landen, Michael O’Grady, Robert Phillips, and Helga Rippen. A sixth new member, Barbara Evans, was unable to attend.
Updates from the Department
- ASPE―Jim Scanlon
- ONC―Steve Posnack (slides)
- CMS―Shana Olshan
Mr. Scanlon reported on recent personnel changes; revisions to the HHS Strategic Plan and ASPE monitoring of progress toward the objectives; and the activities to monitor the impact of the ACA. Four Data Council work groups are looking at alignment within and among surveys in the areas of health insurance, behavioral health, tobacco control, and LGBT data. Mr. Scanlon said he would share with NCVHS the draft questions for best practices being proposed in these areas. He suggested that NCVHS request a briefing on the redesign of the NHIS.
Mr. Posnack reported on the recently-published 10-year Nationwide Interoperability Roadmap. The Roadmap has three overarching goals and timeline milestones in three, six, and ten-year increments, with subsections on “calls to action” and “commitments” for each increment. He stressed that this is a nationwide interoperability roadmap. The three themes around which it is organized are the drivers for interoperability, policy and technical components (the largest section), and outcomes.
Ms. Olshan’s headline was that “all signs to date indicate that the ICD-10 implementation has gone very well.” Now, she said, the National Standards Group can shift its focus to its other administrative simplification responsibilities. She shared an evaluation framework for considering recommendations for new standards and operating rules. Dr. Suarez suggested asking for a formal presentation on ICD-11, to follow on the report on ICD-10 forthcoming from Ms. Pickett. Ms. Kloss urged that a formal assessment be conducted of how the transition worked, or didn’t, to capture change management lessons that can be applied next time.
Briefings from Ms. Seeger on OCR and Ms. Savage on ONC Privacy and Security occurred later in the meeting.
ACA Review Committee Briefing: June Hearing (slides) ― Ms. Goss, Ms. Deutsch, Mr. Soonthornsima
This session presented the Review Committee’s initial thinking on the themes it heard at its June 2015 hearing from 77 testifiers, plus written comments. It plans to submit a formal report and proposed recommendations at the February 2016 NCVHS meeting. Ms. Deutsch gave some background on the Review Committee. The purpose of the June hearing was to determine the extent to which existing standards and operating rules meet the business needs of the health care industry and, if not, how this can be rectified. It focused on six HIPAA transactions plus coordination of benefits. Industry representatives provided considerable information. The group discussed plans for completing the summary report of the hearing.
ICD-10-CM Implementation―Donna Pickett, Director, Standards Group, NCHS
ICD-10, like ICD-9, is used in the public health space and in vital and health statistics as well as in health care administration. Ms. Pickett said public health programs have not yet seen the influx of ICD-10-coded data, but they have been preparing for them. ICD-10 allows expanded details that may result in changes in analytics and reporting.
Ms. Love noted that NAHDO.org has a MapIT tool, webinars, SAS tools, and conversion tools. She offered examples of the fact that while some things are lost, much is gained with the new coding schema. In response to member questions about comparability ratios and an overall evaluation plan, Ms. Bebee said ASPE is looking at having an expert panel advise NCHS on this; she added that NCVHS would be kept abreast of this effort.
Ms. Pickett called attention to the fact that because of a four-year partial freeze on updates to ICD-9-CM, the first update to ICD-10 will involve more changes than usual. Members urged CMS and NCHS to start preparing the industry for an extensive annual update in October 2016. Regarding ICD-11, Ms. Pickett said NCHS would bring forward a panel to give a high-level overview on this topic at the February NCVHS meeting.
Advancing Community-Level Core Measurement―Drs. Stead and Cohen (slides)
The Co-Chairs of the Subcommittee on Population Health reported on its November 17 workshop, “Advancing Community-level Core Measurement: Proposing a Roadmap for HHS.” Dr. Stead thanked Dr. Denise Koo and Acting Assistant Secretary for Health Dr. Karen DeSalvo for recognizing the synergy between the goals of the Office of the Assistant Secretary for Health (OASH) and NCVHS and using the National Committee’s convening authority to advance both efforts. The workshop had two purposes: 1) Identifying a balanced and parsimonious set of domains through which multi-sectoral community partnerships can assess, measure, and improve local health and well-being. These domains must encompass the key determinants of health and be consistent across all geographic levels. 2) Drafting a Roadmap for the Department of Health and Human Services (HHS) to advance well-informed, community-driven action by promoting such a set of domains, along with suggested measures, to facilitate greater availability and use of data within communities. As “straw domains” to focus the discussion, Dr. Koo presented the Measures of Community Health she developed for OASH, and participants were asked to provide input and feedback on the conceptual measurement framework and the domains.
There was strong consensus among participants that the overarching purpose of the effort is to improve community health and well-being through support for multi-sector collaboration at the sub-county level. They also agreed on the potential value of a core set of cross-cutting domains, and stressed the critical need for sub-county-level data, the importance of greater collaboration across federal agencies and programs, and the need for an environmental scan to understand how other sectors are approaching measurement at the community level.
Dr. Stead said the Subcommittee would present a report on the workshop at the February meeting, not including any recommendations. Dr. Cohen outlined the themes taking shape for development into recommendations to be considered at the June meeting.
Acting Assistant Secretary for Health: Comments and Conversation
Acting Assistant Secretary Dr. DeSalvo shared an overview of her team’s thinking and its desire to partner in the work to improve the health of the nation. Expanding health care coverage through the ACA has given public health leaders the opportunity to lead combined efforts for impact on all the determinants of health, to improve community health and well-being. The work toward this goal must begin, she said, by rethinking the definition of health and the levers for advancing it. Dr. DeSalvo calls the public-health-led, multi-sectoral effort to measure and impact these determinants “Public Health 3.0.” She noted that such a joint effort requires a set of shared measures. She wants to put a structure in place that enables communities to measure, compare themselves to others, and show progress based on collective investments. This is the genesis of the HHS/OASH Measures of Community Health framework described above. She concluded by stressing her desire to partner with NCVHS in this effort.
Dr. DeSalvo’s comments prompted a rich discussion with NCVHS members, which Dr. Suarez began by telling her she had found a partner in the National Committee. Members noted the fruitful November 17 workshop, and acknowledged Dr. Koo’s many contributions. Dr. Cohen celebrated the “phenomenal synchronicity” between OASH and NCVHS around their shared goals. Dr. DeSalvo stressed the importance of moving beyond a national preoccupation with health care as the solution, and creating partnerships between health care, public health, and other sectors with public health as “the natural leader.” She cited the collective impact model as a strong basis for a shared vision and language.
Following the conversation with Dr. DeSalvo, Dr. Stead outlined the Population Health Subcommittee’s current thinking about its goals and work plan for the coming year.
Subcommittee on Standards ―Ms. Goss, Mr. Soonthornsima, Ms. Deutsch (slides)
This session gave an overview of the Subcommittee’s responsibilities and its work plan for the near term. In response, new members had questions that prompted discussion about how NCVHS structures and prioritizes the work carried on by its subgroups. An overarching theme was the emphasis on convergence and coordination across the work streams.
Ms. Deutsch outlined the Subcommittee’s plans for operating rules/phase 4 activities. The Standards Subcommittee plans to hold a hearing in February 2016 to gather feedback from stakeholders on operating rules that have not yet been adopted. It was asked to hold this hearing by CORE, the operating rule authoring entity. Dr. Suarez then briefed the Committee on attachments. He expressed hope that after the February hearing, NCVHS would be able to develop a recommendation to the Secretary about attachment standards.
Working Group on HHS Data Access and Use―Dr. Mays
Dr. Mays explained the background and functions of the Working Group for the benefit of new members. It was formed at the request of HHS as an NCVHS work group. Any formal recommendations to the Secretary go through the usual NCVHS vetting and approval process. Generally, however, it is meant to be nimble and give informal advice to entities within HHS. In addition to having one representative from each NCVHS Subcommittee, its other members are consultants who volunteer their time to serve.
NCHS Update―Charles Rothwell, Director
After thanking NCVHS members for their service, Mr. Rothwell gave updates on NCHS surveys. There is an overall push at NCHS to improve the speed of data release, yielding significant improvements in this area. NCHS now releases data briefs on NHANES and follows up with journal articles that provide greater detail. Reporting on vitals has sped up to the point that it now provides surveillance capability. NCHS is also working with state partners to improve data quality, notably in death certificates. He commented on the issues related to response rates. Another challenge is to limit the number of survey questions, which is necessary to keep the length of surveys manageable. NCHS plans to have a core set of questions and another set that rotates in and out. Finally, he expressed hope that NCVHS can develop a closer relationship with the NCHS Board of Scientific Counselors.
Subcommittee on Privacy, Confidentiality and Security―Ms. Kloss
Ms. Kloss reviewed the Subcommittee’s past activities and presented its goals for the coming year. It will hold a call to process the possible projects and develop a work plan. After noting that the Subcommittee coordinates it work carefully with OCR and ONC, she welcomed representatives from these offices for briefings to the Committee.
- HHS Office for Civil Rights ―Rachel Seeger (slides)
Ms. Seeger reported that Secretary Burwell has acknowledged the recommendations of NCVHS on financial services in Section 1179 and said that the Department will share and carefully consider them. Ms. Seeger then introduced a new OCR platform for mobile health developers, designed to help OCR understand the concerns of developers who are new to the health care industry and to HIPAA standards. Their input will be considered in OCR’s decisions about priorities. OCR plans the following activities: a final NICS rule (now at OMB); access guidance and FAQs; and more guidance, including on cloud computing. Ms. Seeger also described the cross-cutting work being done by OCR and ONC on m-health. They are working on a tool for developers and others to walk through via a mobile platform.
- ONC Chief Privacy Officer―Lucia Savage, JD
Ms. Savage said the collaborative work on m-health envisions a tool like TurboTax. The goal is to give developers the privacy and security tools they need to meet consumers’ expectations. This tool is expected to be ready in early 2016; it is already in FTC’s hands. She thanked Ms. Kloss for her recent testimony on the NCVHS data stewardship toolkit, which was featured in a recent report to the White House. On another subject, she suggested that NCVHS ask Elise Anthony at ONC for a briefing on the new data collection features of the 2015 rule.
She then talked about three topics in the consumer privacy and security space related to that rule, which takes effect for equipment in January 2018. First is the requirement that certified EHR technology make APIs (standardized application program interfaces) available to developers for use in creating systems for consumers to “knock on the doors” of certified EHRs. Second, the rule requires developers to offer individuals a choice between encrypted and unencrypted email for transmitting copies of their records. The final provisions concern data segmentation for privacy. A new joint task force on privacy and security issues related to health care APIs will kick off on November 30 and run until May. The meetings are open to the public, and people can dial in. Ms. Savage offered to brief the Committee further on this request.
Finally, she talked about the work on health information security, and mentioned the effort to synchronize and align privacy regulation to make it less confusing, and ONC projects on patient-generated data and precision medicine.
NCVHS Goals and Objectives, Strategic Plans, and Next Steps
Members reviewed a document on NCVHS mission, goals, and objectives that has been under development for several months and is designed as the framework for coordinating Subcommittee work plans. In this context, Subcommittee chairs briefly outlined their plans for 2016 and beyond. Mr. Scanlon offered a few suggestions about choosing projects and setting priorities.
DETAILED SUMMARY
―Day One―
Welcome and Introductions
Dr. Suarez applauded the fact that the Committee has its full complement of 18 members for the first time in several years, and welcomed five new NCVHS members to the meeting: Nicholas Coussoule, Richard Landen, Michael O’Grady, Robert Phillips, and Helga Rippen. (The meeting transcript includes their self-introductions.) A sixth new member, Barbara Evans, was unable to attend. After reviewing the agenda, introductions, thanking NCHS for hosting the meeting, and commenting on convergence, Dr. Suarez welcomed Mr. Scanlon.
Updates from the Department
- ASPE―Jim Scanlon
Mr. Scanlon noted these HHS personnel developments: Karen DeSalvo is the Acting Assistant Secretary for Health; Suzanna Fox is the HHS Chief Technology Officer; Steve Cohen is retiring; and Pete Delaney of SAMHSA is on detail with the Office of the National Drug Control Policy.
HHS has begun working on the 2017 budget and has updated its strategic plan for 2014-18. The plan has four goals and 21 objectives. In addition, there are many targeted strategic plans, action plans, and initiatives, all coordinated by ASPE, which also coordinates the measurement of progress on the plans’ objectives. A proposal is out to revise the Common Rule for human participants research. The comment period has closed on a proposal on non-discrimination in health care.
Work continues on ACA implementation and monitoring access and impact, using national surveys and administrative data, following a robust strategy. There are efforts to enroll those registered in the 16 insurance co-ops that recently closed in other markets. A related HHS initiative concerns delivery system reform, with emphases on using information technology, bundling services, focusing on value, and coordinating care.
Mr. Scanlon shared his view that NCVHS is “at its best when it is providing an overall view of how we bring these various streams of data, standardization, data quality together to improve health and health care.” He endorsed the Committee’s emphasis on convergence and alignment, which HHS shares. Four Data Council work groups are looking at alignment within and among surveys related to health insurance, behavioral health, tobacco control, and LGBT data. Mr. Scanlon said he would share the draft questions for best practices being proposed in these four areas. The Data Council is also working toward more reliable health and human services data on several vulnerable populations, including American Indian and tribal populations.
In the discussion period, NCVHS members had questions for Mr. Scanlon about ACA coverage, strategies for minimizing the impact of budget cuts on survey data, analysis of health outcomes for newly insured populations, ways to coordinate more closely with the Data Council, and the impact of anticipated changes in race and ethnicity categorization by the Census Bureau. Dr. Mays suggested that NCVHS write a letter recommending augmentation of funds for the redesign of the NHIS, and Mr. Scanlon suggested that the Committee ask for an NCHS briefing on this topic. There was also discussion of issues related to the all-payer claims databases on which Mr. Scanlon said HHS “would be open to a letter.”
ONC: Steve Posnack (slides)
After noting that ONC updated the Federal Health IT Strategic Plan in October, Mr. Posnack focused on the recently-published 10-year Nationwide Interoperability Roadmap. The process began in June 2014 with a concept paper that generated a lot of feedback from ONC’s FACAs and public stakeholders. The comments revealed among other things confusion about privacy and security, the need for greater clarity on standards, mixed feedback on governance, and calls for unique health identifiers.
ONC developed ten principles that underlie interoperability starting with building on the existing health IT infrastructure. The roadmap has three overarching goals and timeline milestones in three, six, and ten-year increments, with subsections on “calls to action” and “commitments” for each increment. He stressed that this is a nationwide interoperability roadmap, “not our roadmap”; and it is envisioned as a living document that will be tracked and revised over time. The three themes around which it is organized are the drivers for interoperability, policy and technical components (the largest section), and outcomes. He stressed the importance of developing the ability to measure and understand the clinical outcomes that result from interoperability. At the end of the Roadmap are “tear-away sheets” consisting of tables for each of the subsections, with the milestones for each increment.
In the discussion period, members had comments and questions related to the forthcoming NCVHS hearing, security, implementation of the Roadmap through “the actual workings of the system,” and ONC’s other priorities. As priorities, Mr. Posnack mentioned clinical quality measurement, privacy and security, precision medicine, and delivery system reform. Other questions concerned the ONC vision of a learning system (he cited the IOM vision), sustaining the Roadmap through changes in leadership, and individual access to personal health information.
- Shana Olshan, CMS (by phone)
Ms. Olshan’s headline was that “all signs to date indicate that the ICD-10 implementation has gone very well.” The HIMSS ICD-10 Task Force has been interviewing payers, clearinghouses and providers about their experience with implementation, and will share the feedback in December. Over all, the reports are positive.
Now, she said, she will shift her focus to the other administrative simplification responsibilities of the National Standards Group. After noting the useful testimony at the Review Committee’s June hearing, she shared an evaluation framework for considering recommendations for new standards and operating rules. Its four principles are that proposed solutions must 1) solve a problem or business need, 2) lead to administrative simplification across the industry over the long term, 3) allow for flexibility or adaptability to respond to changes and not stymie innovation, and 4) be enforceable. She elaborated on each principle, noting among other things that her team is developing a comprehensive enforcement strategy to ensure consequences for lack of compliance.
Dr. Suarez began the discussion period by noting the alignment between the CMS framework for evaluating recommendations and the Committee’s and Review Committee’s approach. Ms. Goss welcomed further opportunity to dialog about this and to build the partnership between CMS and the Review Committee. Other questions and comments concerned pending regulations and what is down the road from ICD-10. Dr. Suarez suggested asking for a formal presentation on ICD-11 to follow on the report on ICD-10 forthcoming from Ms. Pickett. Ms. Kloss urged that a formal assessment be conducted of how the transition worked, or didn’t, to capture change management lessons that can be applied next time. She noted that the challenge is to look broadly at classifications, vocabularies, and code sets “as a family of special, complex change that we need to figure out how to do as an industry more efficiently.” Dr. Suarez endorsed this goal, and Mr. Soonthornsima agreed that the idea is to more completely align the changes in different domains. Dr. Mays noted, for example, the issues in the mental health area related to DSM-5 and ICD, as well as the need for training. Others cited the importance of sequencing so that the various roadmaps intersect constructively.
ACA Review Committee Briefing: June Hearing (slides)―Ms. Goss, Ms. Deutsch, Mr. Soonthornsima
Ms. Goss stressed that this session would present the Review Committee’s initial thinking on the themes it heard from 77 testifiers at its June 2015 hearing, plus written comments. It plans to submit a formal report and proposed recommendations at the February 2016 NCVHS meeting.
Ms. Deutsch explained that the Review Committee was mandated by a statute under the ACA, which also requires a hearing no less than biannually followed by recommendations to the Secretary. NCVHS was designated as the Review Committee, and delegated this function to the Subcommittee on Standards. The purpose of the June hearing was to determine the extent to which existing standards and operating rules meet the business needs of the health care industry and, if not, how this can be rectified. Testifiers responded to questions they were provided in advance regarding the current status of HIPAA transactions and their standards and operating rules, the extent to which they meet business needs, how implementation went, the ability to meet new or emerging needs, and what changes are needed. The hearing focused on six HIPAA transactions plus coordination of benefits. Industry provided considerable information in response to the questions.
Mr. Soonthornsima said the hearing showed that there has been significant progress on some standards, but not all standards and operating rules are broadly or consistently adopted, due to obstacles including cost, complexity, timing factors, and dependency on other stakeholders (e.g., vendors). He noted that in some cases, even if a standard is adopted it may not be utilized. Ms. Goss added that piloting and testing are core issues. The four themes of the feedback were agility/applicability; usability/enforceability; sustainability; and education and assistance. Some testimony included suggestions for targeted forms of education.
The Review Committee will hold follow-up calls to finish vetting the industry feedback and develop the report for February. Most of the ensuing discussion focused on planning for completing this challenging task in the short time available.
ICD-10-CM Implementation―Donna Pickett, Director, Standards Group, NCHS
Dr. Suarez noted that ICD-10, like ICD-9, is used in the public health space, in vital and health statistics as well as in health care administration. Ms. Pickett was asked to focus on the first two of these arenas. He reiterated that NCVHS will ask for a subsequent presentation on ICD-11 and other topics related to ICD.
Ms. Pickett, who is also Co-Chair of the ICD Coordinating and Maintenance Committee, noted that the U.S. has used ICD-10 for death certificate reporting since 1999. She said today’s presentation would look at the public health use and impact of ICD-10 code sets. Public health programs have not yet seen the influx of ICD-10-coded data, but they have been preparing for them. For example, AHRQ has information about the migration of tools to ICD-10. Some CDC programs that receive coded data have provided instructions to partners on how to submit them. FDA, AHRQ, and several other HHS operating divisions anticipate having ICD-10 data in the second quarter of 2016. The analytic part has not yet begun. ICD-10 allows expanded details that may result in changes in analytics and reporting.
Ms. Love reported on the NAHDO perspective, noting that ICD-10 has caused programs to reassess ICD-9-CM base codes. NAHDO.org has a MapIT tool, webinars, SAS tools, and conversion tools. She offered examples of the fact that while some things are lost, much is gained with the new coding schema.
In response to member questions about comparability ratios and an overall evaluation plan, Ms. Burke-Bebee said ASPE is looking at having an expert panel advise NCHS on this, and it is also looking at recoding some surveys. She added that NCVHS would be kept abreast of this effort.
Dr. Mays called attention to the fact that NIMH is discontinuing the use of DSM-5 for coding behavioral health, with implications for research, and Ms. Burke-Bebee said they would look into this. Dr. Phillips commented on double-coding, which launched a discussion of coding for clinicians and recognition that the issues in that setting differ from the ones in a population health setting. Dr. Suarez noted the implications for quality reporting.
Ms. Pickett noted that because of a four-year partial freeze on updates to ICD-9-CM, the first update to ICD-10 will involve more changes than usual. Members urged CMS and NCHS to start preparing the industry for an extensive annual update in October 2016.
Regarding ICD-11, Ms. Pickett said NCHS would bring forward a panel to give a high-level overview on this at the February NCVHS meeting. She predicted that it would be many years before such a change.
Advancing Community-Level Core Measurement―Drs. Stead and Cohen (slides)
The Subcommittee on Population Health Co-Chairs reported on the November 17 workshop, “Advancing Community-level Core Measurement: Proposing a Roadmap for HHS.” Dr. Stead began by thanking Dr. Denise Koo and Acting Assistant Secretary for Health Dr. Karen DeSalvo for recognizing the synergy between the goals of the Office of the Assistant Secretary for Health (OASH) and NCVHS, and for using the National Committee’s convening authority to advance both efforts. Some 100 people participated in the workshop, coming from both health-related and non-health-related organizations, inside and outside government and at all levels (local, state, national). They contributed deep expertise about the topic.
The workshop had two purposes: 1) Identifying a balanced and parsimonious set of domains through which multi-sectoral community partnerships can assess, measure, and improve local health and well-being. These domains must encompass the key determinants of health and be consistent across all geographic levels. 2) Drafting a Roadmap for the Department of Health and Human Services (HHS) to advance well-informed, community-driven action by promoting such a set of domains, along with suggested measures, to facilitate greater availability and use of data within communities. As “straw domains” to focus the discussion, Dr. Koo presented the Measures of Community Health she developed for OASH (as described at the September NCVHS meeting), and participants were asked to provide input and feedback on the conceptual framework and the domains.
There was strong consensus among participants on the overarching purpose of the effort―to improve community health and well-being through support for multi-sector collaboration at the sub-county level; and on the value of a core set of cross-cutting domains to provide a common language, help communities assess their status, and help different sectors see where to focus for collective impact. Participants also agreed on the critical need for sub-county-level data, the importance of greater collaboration across federal agencies and programs, and the need for an environmental scan to understand how other sectors are approaching measurement at the community level. The areas of challenge have to do with achieving parsimony while including all key sectors; meeting other sectors where they are; focusing not just on determinants but also on health equity and life course; and supporting both assessment and local action. Ms. Booth presented her summary of the participants’ top recommendations for next steps by NCVHS to keep this effort moving ahead.
Dr. Stead said the Subcommittee would present a summary report on the workshop at the February meeting, not including any recommendations.
Dr. Cohen outlined the themes taking shape for development into recommendations to be considered at the June meeting. They fall into two buckets:
Content foci: Perform an environmental scan on domain and indicator data sets used in federal agencies and programs; develop multi-sectorial indicators for use by different agencies and different objectives; and develop a menu of metrics for communities to select from for measurement around local priorities.
Methodological foci: Review data sets available at geographic levels, (e.g., ACS) and determine how to make them more accessible and usable; create easy-to-use data portals; and develop easy-to-use guidance and resources to help communities implement their own community surveys.
Dr. Suarez then welcomed Karen DeSalvo, MD, the Acting Assistant Secretary for Health and National Coordinator for Health Information Technology.
Acting Assistant Secretary for Health: Comments and Conversation
Dr. DeSalvo said she wanted to share an overview of what her team is thinking about and wants to partner on in the work to improve health. She acknowledged that she is “preaching to the choir.” This is an exciting moment in the history of health in the U.S., when expanding coverage through the ACA makes it possible to widen the focus from health care and access to the many other determinants of health. Public health has an opportunity to move into the role of convener. Data have already changed the landscape, and there is an opportunity to further leverage data for health. In sum, this is an inflection point that calls us to action, starting with rethinking the definition of health and the levers for advancing it. The collective impact model requires having something to measure and monitor. The question is what to measure, especially at the community level where few indicators are available. The country’s difficulty in conceptualizing how to measure, monitor, and improve health is at its core a responsibility problem; this calls for a cultural shift to a sense of shared responsibility and accountability for improving community well-being.
A stronger public health infrastructure is needed to keep the movement going on the ground. Dr. DeSalvo calls this “Public Health 3.0”―i.e., public health that is “ready and strong to work across sectors to address the multiple determinants of health and work toward a set of shared measures.” She wants to put a “really big wedge in the door to HHS” to help enable communities to “measure success.” Today’s data and measures don’t work for policy makers; what is needed instead are rapid-cycle measures that tap into new data sources and bring quality improvement to policy action on the ground. Her goal is to put structure in place so that communities can measure, compare themselves to others, and show progress based on collective investments. The structure must be straightforward enough that everyone can understand it and it is accessible to even the smallest county health department with the smallest staff. After expressing a “very strong sense of urgency about what can and should get done,” she cited the convergence of opportunity represented by people’s willingness to tackle this problem, and she stressed her desire to partner with NCVHS in this effort.
Dr. Suarez responded that she had found a partner in the National Committee. Noting the valuable workshop the previous day and acknowledging Dr. Koo’s many contributions as a collaborator, he said NCVHS is on a pathway to helping define the concepts OASH is working on. There is good information at national, state, and individual levels; communities are where the information gaps are. He also noted the shift in focus to wellness, well-being and health equity.
Dr. Cohen celebrated the “phenomenal synchronicity” between OASH and NCVHS around these goals, and he noted the need for a culture change in federal government around the definition of health and the role of communities as the central building block. He recalled the excitement shown by the representatives of non-health agencies at the workshop, and Mr. Rothwell’s promise to talk to the directors of other federal statistical agencies about the idea of a set of common domains in which each agency could drill down in its area of interest.
In response to a comment about the need to build community competence to take the data and act on them, Dr. DeSalvo said she has “a lot of confidence in communities,” especially if we don’t make it more complicated than necessary. She suggested that will is a greater factor than competence. Other themes of the discussion included the overlooked significance of the community’s influence on the individual; the question of how to sustain change over the long term; the potential influence of democratized data in this arena; and the need to avoid increasing the data-collection burden on physicians.
Dr. DeSalvo stressed the importance of moving beyond a national preoccupation with health care as the solution and creating partnerships between health care, public health, and other sectors, with public health as “the natural leader.” She added that public health, too, needs to change―something that is happening through the push for accreditation. The Public Health 3.0 concept envisions a new kind of public health leader, the skill-sets this entails, and how these skills can be built into the incumbent workforce. Responding to a comment about the multi-factorial nature of well-being, she cited the Health in All Policies principle, adding that every community will be a little different. Asked how to ensure that this vision resonates with people of all political persuasions, she cited the collective impact model as a basis for a shared vision and language. She added her belief that “we have natural allies that we have not tapped into in this space,” such as business and elected officials. The challenge is to work outside of traditional partnerships and sectors.
Finally, responding to the lament that “the value of data accrues across many partners, but nobody wants to pay for it,” Dr. DeSalvo called attention to new work at ONC around a public utility model for health information, following the lead of some states. The 2015 certification rule would require by 2018 that all EHRs have a generic, publicly-facing doorway (an API) to data for patients, with appropriate security and consents. The purpose is to show consumers that their electronic health information can be shared according to their wishes.
Reflections on the Conversation with Dr. DeSalvo, the Workshop, and Next Steps
Members expressed appreciation for the structure and context that Dr. DeSalvo provided to help them process the Workshop findings and consider priorities for moving forward. Some members suggested developing a model for analyzing the impacts of different interventions on community risk factors. Rather than requiring additional federal resources, Dr. Cohen stressed the need to repurpose existing resources and figure out how communities can avail themselves of the expertise that resides at the federal level.
Dr. Stead outlined the Subcommittee’s current thinking about the goals and work plan for the coming year. In brief, it will present a report on the project and the workshop at the February meeting. It will then develop recommendations and a letter to the Secretary and submit it for review and approval at the June NCVHS meeting. It is looking into commissioning a multi-sector environmental scan of non-health domains and data in the near term. It hopes to convene another meeting similar to the one just held on November 17 for next November, to continue the work. It will continue to refine the roadmap for the HHS role in this effort. The Subcommittee hopes to turn this project over to other entities by early 2017 so it can work on other priorities.
Dr. O’Grady commented on potential roles for other federal agencies, especially the federal statistical agencies, and suggested asking OMB (home of the Chief Statistician of the US) to make this project a priority. He also wondered if other agencies have FACAs like NCVHS.
Subcommittee on Standards ―Ms. Goss, Mr. Soonthornsima, Ms. Deutsch (slides)
This session gave an overview of the Subcommittee’s responsibilities and its work plan for the near term. Ms. Goss reviewed the Subcommittee’s focus areas, many of which are driven by the Committee’s legislative obligations related to HIPAA administrative simplification and ACA provisions. Other focal areas relate to 1) advancements, evolution, and convergence of standards and 2) the convergence of health and health care. (See slides for details.) The nine health care transactions relate to different stages of the business process. NCVHS regularly reports to Congress on the status of HIPAA administrative simplification.
The concept of convergence is important for NCVHS; for the Standards Subcommittee, that includes keeping administrative messaging apace with changes and needs in health and health care, and aligning HITECH and HIPAA. Topics on the Subcommittee’s radar include public health data standards, all-payers claims databases, and pay for performance. In addition, other data use needs that must be mapped back into standards include those related to long-term care or mental health, areas where the greatest gaps and opportunities often lie. The Subcommittee also oversees the National Committee’s responsibilities as the ACA Review Committee, which focuses on standards that have already been adopted.
In response to this overview, several new members had observations and questions that prompted discussion about how NCVHS structures and prioritizes the work of its subgroups. An overarching theme was the emphasis on convergence and coordination across the work streams.
Ms. Deutsch outlined the Subcommittee’s plans for operating rules/phase 4 activities, after reviewing phases 2 and 3 and the contents of a 2014 NCVHS letter on the subject. The Standards Subcommittee plans to hold a hearing in February 2016 to gather feedback from stakeholders on operating rules that have not yet been adopted (health care claims, enrollment, dis-enrollment, premium payment, and prior authorization). It was asked to hold this hearing by CORE, the operating rule authoring entity. The Subcommittee has developed questions for testifiers that align with those being used to evaluate adopted standards using the same criteria. People can submit written feedback to augment their 5 minutes of testimony; and some will submit only written testimony.
Dr. Suarez then briefed the Committee on attachments, starting with a review of past NCVHS work on the subject including a 2013 letter and recommendations. He called attachments “one of the most significant transactions.” X12, HL7, and LOINC have developed standards for this transaction. The HL7 attachment work group has developed a new version of an implementation guide, with conformance criteria so it can be adopted. It is going through the validation process now. At the February hearing, NCVHS will be briefed by HL7 about that and also by X12 and LOINC about their relevant work. He expressed hope that NCVHS will then be able to develop a recommendation to the Secretary about the adoption of the attachment standards.
Working Group on HHS Data Access and Use―Dr. Mays
Dr. Mays explained the background and functions of the Working Group for the benefit of new members. It was formed at the request of HHS as an NCVHS work group; any formal recommendations to the Secretary go through the usual NCVHS vetting and approval process. Generally, however, it is meant to be nimble and to give informal advice to entities within HHS―for example, to SAMHSA on how to get its data out faster and better. In addition to having one representative from each NCVHS Subcommittee, its other members are consultants who volunteer their time to serve. In general, they like to work on specific problems referred to them by people in HHS and/or NCVHS related to improving HHS data access and use. Requests come primarily from Mr. Scanlon and Damon Davis, who runs the HHS IDEA Lab. In addition, the Working Group sometimes is asked to advise NCVHS subcommittees on communications topics such as dissemination of the data stewardship toolkit. Dr. Mays also told the Committee about the current thinking on an informal blog on topics of interest to the working group that one of its members would maintain.
The overview prompted a number questions and comments from new members in an attempt to understand the purpose and functions of the group and its functional relationship to NCVHS. One topic concerned possible revisions to the group’s name and charge. The Committee agreed to revisit the charge on the second day of this meeting and to ask Mr. Scanlon to review the proposed revisions.
―Day Two―
NCHS Update―Charles Rothwell, Director
Mr. Rothwell began by thanking NCVHS members for their service, stressing that “this is what makes government work” and government does “need guidance.” NCHS is one of 13 federal statistical agencies (FSAs), whose directors meet on a regular basis. At such a meeting on the previous day, he told his fellow FSA directors about the new NCVHS project on cross-cutting community indicators, and they are interested in learning how they can help.
He gave updates on NCHS surveys, starting with NHANES. There is an overall push at NCHS to improve the speed of data release, which is yielding significant improvements in this area. NCHS now releases data briefs on NHANES and follows up with journal articles that provide greater detail. NCHS is doing quarterly estimates for health insurance, and it publishes health indicators. Reporting on vitals has sped up to the point that it now provides surveillance capability, such as for monitoring the flu. In 2016, high-risk birth events will be added to the quarterly vitals report. NCHS is also working with state partners to improve data quality, notably in death certificates.
On the data briefs, Mr. Rothwell acknowledged the contributions of Jenifer Madans, NCHS Associate Director for Science, who just received the American Statistical Association’s highest award. The role of NCHS is not to say anything about policy, but simply to inform the debate; this alone sometimes “puts us in the crosshairs.”
He commented on the issues related to response rates, which are at 70 percent―far better than the 5-10 percent rates of private industry. Another challenge is to limit the number of survey questions; this frustrates agencies looking for information, but is necessary to keep the length of surveys manageable. NCHS plans to have a core set of questions and another set that rotates in and out. It would like to test the questions, but lacks the money to do this. The Data Council is trying to align the surveys better, internally and externally. Finally, Mr. Rothwell expressed his hope that NCVHS can develop a closer relationship with the NCHS Board of Scientific Counselors.
In the discussion period, members applauded Mr. Rothwell’s successful efforts to improve the timeliness of survey data release. Regarding revisions to race and ethnicity categories, Dr. Queen said Census and OMB have a large workgroup that is engaged in a lengthy process on this. Nothing will happen without involvement across the federal statistical system. Mr. Rothwell added that these changes will be driven this time by the Census director. A member encouraged NCHS to add infographics to its issue briefs so they appeal to a broader audience. Mr. Rothwell shared his view that Health US should be completely automated as a regularly updated database, with visualizations. Asked about funding for the NHIS redesign, he commented on the ways in which the structure of federal funding limits innovation.
Dr. O’Grady called attention to the fact that researchers widely use NHANES to look at the wider implications of clinical trials. To a question from Ms. Love about possible changes in the hospital surveys, Mr. Rothwell commented on the challenges related to standardization of EHRs. She suggested that NCHS serve as “the nexus of hybridization between administrative data and enhanced clinical feeds.” Mr. Scanlon followed with comments about Meaningful Use stage 2.5. He also mentioned the ASPE evaluation fund, which can be used to fund some testing and implementation of innovations. He reiterated his frequent point that “no one is getting increases in their budgets,” and what the new fiscal year will hold is unknown.
Subcommittee on Privacy, Confidentiality and Security―Ms. Kloss
After noting that she is lacking a co-chair for this Subcommittee and making a pitch for new members (as all Subcommittee chairs did during the meeting), Ms. Kloss reviewed its past activities and presented its goals for the coming year. Most recently, the Subcommittee held a hearing in May 2015 on the 1179 exemption to HIPAA, with a letter to the Secretary on the subject approved at the September meeting. She described its major points. She encouraged new members to review the large volume of NCVHS contributions in this area since the late 1990s. The relevant documents are posted on the NCVHS website.
After observing that the Subcommittee coordinates it work carefully with OCR and ONC, Ms. Kloss welcomed representatives from these offices for briefings to the Committee. (See below.) Following these two presentations, she briefly reviewed the thinking about possible projects for the coming year or more, as input to the forthcoming strategic planning discussion. The possibilities include developing guidance on “minimum necessary”, putting the issue of de-identification and re-identification into lay language, commenting on the forthcoming OCR request for information on harm and civil monetary penalties, thinking about the long-range future of health privacy, and the privacy implications of predictive analytics and algorithmic transparency. Dr. Stead suggested working for an industry-wide understanding regarding opt-ins and opt-outs. Dr. Mays raised the need for guidance on CFR42 part 2. Ms. Kloss said there would be a Subcommittee call to process the possibilities.
- HHS Office for Civil Rights ―Rachel Seeger (slides)
Ms. Seeger said she just received a letter sent on behalf of Secretary Burwell acknowledging the recommendations of NCVHS on financial services in Section 1179, which the Department will share and carefully consider. The letter also thanks NCVHS members for their efforts. Ms. Seeger reported that Ms. Kloss met with Deven McGraw, Deputy Director for Health Information and Privacy, to discuss potential joint projects.
Turning to recent activities, she reported that OCR has launched a platform for mobile health developers, designed to help OCR understand the concerns of developers new to the health care industry and to HIPAA standards. Users can submit questions and comments and vote on the relevancy of various topics. This input will be considered in OCR’s decisions about priorities http://hipaaQsportal.hhs.gov. She showed several screen shots of the portal and said that one burning question is, Are we a HIPAA-covered entity? There are also questions on patient-generated protected health data. In general, OCR is able to respond with answers.
OCR plans the following activities: a final NICS rule (it is now at OMB); access guidance and FAQs; and more guidance, including on cloud computing. Ms. Seeger described the cross-cutting work being done by OCR and ONC on m-health. They are working on a tool for developers and others to walk through via a mobile platform.
- ONC Chief Privacy Officer―Lucia Savage, JD
Ms. Savage said the collaborative work on m-health envisions a tool such as TurboTax. The goal is to give developers the privacy and security tools they need to meet consumers’ expectations. This tool is expected to be ready in early 2016; it is already in FTC’s hands.
She thanked Ms. Kloss for her recent testimony on the NCVHS data stewardship toolkit, which was featured in a recent report to the White House. On another subject, she suggested that NCVHS ask Elise Anthony at ONC for a briefing on the new data collection features of the 2015 addition rule.
She then talked about three topics in the consumer privacy and security space related to that rule, which takes effect for equipment in January 2018. The first is the requirement that certified EHR technology make APIs (standardized application program interfaces) available to developers for use in creating systems for consumers to “knock on the doors” of certified EHRs. Second, the rule requires developers to offer individuals a choice between encrypted and unencrypted email for transmitting copies of their records. The final provisions concern data segmentation for privacy. A new joint task force on privacy and security issues related to health care APIs will kick off on November 30 and run until May. The meetings are open to the public, and people can dial in. Ms. Savage offered to brief the Committee further on this request.
Finally, she talked about the work on health information security, which she said ONC regards as “an enabler of interoperability” and also something that “needs to mature pretty significantly.” ONC plans to “beat the drum loudly” on things the industry could do right now to improve security, following the lead of the financial services industry. It is also exploring how to “help people respect the credentialing systems each other has put in place.” There is a broad inter-agency workgroup on security in which OCR participates.
Dr. Mays remarked that it would be good to have a case study of the way that ONC and OCR have worked with entrepreneurs, so others can learn from their example. She urged them also to think about the domain of health and health care research, which are not a HIPAA environment. Ms. Seeger said OCR is working closely with NIH, which is interested in helping provide grantees and others with clear language on privacy protection.
Ms. Savage noted that there is an NPRM on the Common Rule, with a December deadline for comments. Also, there is an effort to synchronize and align privacy regulation and make it less confusing. She also mentioned ONC projects on patient-generated data and precision medicine. Dr. Suarez expressed concern that some API vendors are “portraying themselves as acting on behalf of the consumer and the patient” when there are concerns about what they will do with the data and the potential for fraud and abuse. He noted the disconnects that can occur between consumer desires and expectations, vendors’ interests, provider practices, and legal requirements with respect to information sharing. He also called attention to the significance of the ONC project on patient-generated health data.
One thread of this discussion concerned the role and capacity of ONC to coordinate the disparate activities of federal government in the aforementioned areas, and its role with respect to states. Ms. Goss urged an effort to increase access to the excellent resources being developed by ONC and OCR. Ms. Savage said they would be looking for ways to push the materials out through stakeholder organizations.
NCVHS Goals and Objectives, Strategic Plans, and Next Steps
Members reviewed a document on NCVHS mission, goals, objectives that has been under development for several months and is designed to serve as the framework for coordinating Subcommittee work plans. The document prompted a rich discussion. It was suggested that relevant guiding principles be incorporated into this framework. Members agreed that the sustainability of the health statistics enterprise should be explicitly referenced in the NCVHS strategic framework.
Another suggestion was to use the planning document, when complete, as an outreach tool to orient the broader public to the Committee’s work and make it clear that people are welcome to attend or listen to its meetings. The group discussed cultivating stronger relationship with other federal agencies, especially in view of the current Population Health Subcommittee project on community-level health measurement and development of indicators.
The document will be edited based on the day’s discussion and a final version distributed to members. Its purpose is to shape the subcommittees’ plans for working toward relevant objectives. Dr. Suarez noted that this will be an iterative and evolving process, aimed at creating a more complete picture of the collective work plan by June, 2016. Mr. Scanlon offered his “usual guidance” on “staying in our lane,” prioritizing, “picking projects we think we can do,” and choosing projects for which there is a client who can use it. The Committee should choose things that are enduring and valuable.
The Subcommittee chairs then briefly outlined their plans for 2016 and beyond within the context of the planning document.
Finally, there was brief discussion of the Data Access and Use group, with Mr. Scanlon explaining that FACAs can establish subcommittees and workgroups that are not themselves FACAs. He affirmed that the Department asked for establishment of the Working Group.
There were no public comments.
After further words of welcome to new members, 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/
Chair Date