Herbert Humphrey Building
Washington, DC
The National Committee on Vital and Health Statistics was convened on September 20-21, 2012 at the Herbert Humphrey Building in Washington, DC. The meetings were open to the public.
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Committee Members
Lead Staff and Liaisons
| Others
Working Group on HHS Data Access and Use members present at NCVHS meeting:
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Note: The transcript of this meeting and speakers' slides are posted on the NCVHS Web site. Use the meeting date to locate them. For final versions of NCVHS documents discussed in the meeting, see "Reports and Recommendations."
The Committee approved a letter to the Secretary with findings on health care administrative transactions and administrative simplification from a hearing held in June 2012.
Ms. Buenning briefed the Committee on the EHR incentive program, including the final rule for Stage two of Meaningful Use; publication of the final rule on ICD-10 code sets and the Health Plan Identifier; the work of the CMS privacy staff; and designation of CORE as the authoring entity for the remaining HIPAA standards.
NCVHS members asked for more information in the future on the connections between ICD-10, Meaningful Use, and quality measures, and they offered the Committee’s help on privacy issues in the health insurance exchanges.
Mr. Scanlon reviewed the HHS strategic plan, work on data collection standards for demographic items, and the health systems tracking project that will monitor the progress of health care reform in ten areas. In the HealthData Initiative, HHS is sponsoring hackathons and health data forums to bring the research community, data producers, and the technology community together. It created the NCVHS Working Group on HHS Data Access and Use for the same purpose.
NCVHS members urged the Department to make clear the purpose and nature of the data collection standards, and also to encourage flexibility in data collection. The lack of data for some is lands and territories was noted. Mr. Scanlon was asked what is being done to capture local experiences on use of the data sets in healthdata.gov and the issues that are arising. While acknowledging the importance of evaluation, he said not much ishappening yet in this regard.
Ms. Daniel reported on ONC’s work on standards certification rules, privacy and security, and patient/family engagement. ONC recently held its second consumer health IT summit. Regarding governance of the Nationwide HealthInformation Network, ONC has announced that it will not proceed down the regulatory path at present. Rather, it plans to use available levers, provide guidance, connect HIE service providers, and seek to engage, listen,and learn. Ms. Daniel briefed the Committee on forthcoming hearings of the Health IT Policy and Standards Committees and reported that ONC is creating new workgroups focused on how to use health IT to engage and empower consumers.
Dr. Cohen urged that ONC expand its approach to information access and development of tools and principles to address communities’ need to access and use aggregated, deidentified information to improve local health.
The co-chairs explained that this draft report by the Subcommittee on Privacy, Confidentiality and Security is designed to support and strengthen community health initiatives by clarifying responsibilities related to stewardship of community data. Following an extensive discussion, the Subcommittee revised the letter and presented it for further discussion on day two. The letter will be further revised based on these discussions and presented at the November full Committee meeting.
Dr. Suarez presented a letter based on a June 2012 hearing held by the Subcommittee on Standards. He described its background and key messages. More than 30 testifiers participated in panels on 5010 transactions, operatingrules for eligibility and claims status, ICD-10 code sets, dental code sets, and the process for ACA certification for health plans. The NCVHS letter summarizes the common themes across these topics and makes recommendations in each of them. Full Committee members offered a few suggested revisions, which were worked into a revised version that was presented and approved on day two of this meeting.
Members accepted the Subcommittee’s recommendation that NCVHS wait until next year to write another report to Congress on HIPAA implementation.
The purpose of the day-long August retreat was to develop an NCVHS roadmap for the next few years. Full Committee members discussed two products from the retreat?a set of guiding principles for selecting NCVHS projects, and three overarching and interrelated themes for prioritizing the Committee’s work. The three themes, as revised, are:
These themes and the guiding principles (included in the detailed summary below) will serve as a reference for future NCVHS planning.
The purpose of this special session was to explore Theme One of the three themes outlined above. Most NCVHS members participated, including the co-Chairs of all four subcommittees.
Participants outlined ideas for five possible projects and sub-projects along with cross-cutting suggestions for how to carry out any and all of them. The chief project ideas:
Members agreed that this targeted, joint session is a useful and productive format for future use.
Mr. Scanlon reported that Ms. Milam and Dr. Suarez have been reappointed for another term; Dr. Carr and Dr. Warren have completed their NCVHS tenure; Dr. Carr will continue as Chair of the Working Group on HHS Data Access and Use; and the Secretary has appointed Dr. Green as the next NCVHS Chair. Ms. Greenberg added that the appointments of four new members are in process, and they are expected to join NCVHS in time for the November meeting.
Dr. Green laid out the next steps on empowering communities. Ms. Milam announced that Dr. Cohen would serve as the new co-chair of the Subcommittee on Population Health. Apart from that change and Dr. Green’s Chairmanship the Executive Subcommittee will remain as before.
Heritage is an integrated physicians' network in Southern California. As a fully capitated medical group, it is at risk for both professional and hospital claims, making it essential to control hospital costs and reduce unnecessary hospital utilization. It stratifies its population for that purpose and uses various case management techniques. Heritage created the Heritage Health Prize (which Mr. Gluck manages along with serving as the network's General Counsel) to predict hospitalization and identify members who would benefit from preventive measures in a "real-worldusable" manner. Heritage contracted with Dr. El Emam to de-identify the data released for the prize and ensure that they could not be re-identified. They used technical and legal methods to manage the risk, and commissioned an adversarial attack on the data to determine if the deidentification was stringent enough. The conclusion was that "it would be extremely difficult to re-identify the Heritage Prize data." Dr. El Emam described the de-identification methods used and the technical issues his team faced.
-Day One-
Dr. Carr called the meeting to order, and all present introduced themselves.
In the EHR incentive program, the final rule for stage 2 Meaningful Use was published on September 4. Among other changes, ICD-10 code sets now appear as a reference in EHR certification criteria. Stage 2 allows for batch reporting, and patient engagement is a major focus of this stage. Clinical quality measures reporting will remain the same through 2013. The CMS website has links to the National Coordinator’s final rule on 2014 certification of EHR technology.
CMS published a final rule in the Federal Register on September 5 pushing the compliance date for ICD-10 code sets back to October 1, 2014. Most, though not all, of the 600 public comments it received during the comment period favored this delay, and the decision is considered a fair compromise. In the same final rule, CMS requires health plans to obtain and use the standardized Health Plan Identifier (HPID) in standard transactions. The enumeration system for obtaining the HPID will be outlined in October. The same rule also closed a part D loophole in the National Provider Identifier.
CMS' privacy staff is developing guidance on privacy policy for administration of the new ACA health insurance exchange program, working with the Center for Consumer Information and Insurance Oversight (CCIIO) and other federal agencies.
Ms. Buenning said one of the most significant things CMS has done is to confirm the designation of CORE as the authoring entity for the remaining HIPAA standards, an action that is responsive to NCVHS recommendations.
Dr. Suarez pointed out an apparent disconnect between the ICD-10 compliance date and Meaningful Use stage 2 requirements, which needs clarification and may necessitate a bridge using SNOMED. Ms. Buenning said CMS is starting to make connections between ICD-10, Meaningful Use, and quality measures. Dr. Carr affirmed that NCVHS will want to know more about this.
Dr. Cohen asked how CMS would work with state Medicaid plans and small providers to get them prepared for ICD-10 code sets, and Ms. Buenning described current CMS efforts in that area, especially with small individual practices, using extension services and regional offices. The agency hopes to hold a listening session soon to identify issues and questions regarding compliance and testing. On another subject, she said she would relay the NCVHS offer to help on privacy issues in the exchanges to the director of CMS' privacy policy group.
Mr. Scanlon began his briefing, as usual, by reviewing the HHS strategic plan and its five major goal areas. In addition, there are about nine initiatives and program areas with their own plans and action steps. Reducing disparities in health and health care is a major focus of health care reform, along with the national quality and prevention strategies. Data and evaluation experts are involved in each of these initiatives, usually governed by a council or workgroup.
The ACA required HHS to adopt data collection standards for certain demographic items in all its surveys. HHS has adopted standards for race and ethnicity data that build on the OMB categories, and also has made recommendations on sex, primary language and disability status. The Department was asked to look at standardization for administrative data; this is more difficult than doing so with surveys, and it is exploring the same demographic areas. The Data Council has talked with federal agencies and health plans about these matters, and HHS is deciding what to do regarding SES, an area in which NCVHS did an environmental scan on standards at the Department's request.
The Department's health systems tracking project will monitor the progress of health care reform in ten areas including access to care, cost and affordability, quality, and vulnerable populations. A working group helped identify what to monitor. Mr. Scanlon offered to organize a briefing for NCVHS on these activities. All major HHS surveys and those of the Census Bureau and Labor Department have added indicators related to ACA data needs. A working paper on these activities is posted on the ASPE website. Work lies ahead on how to measure participation in the exchanges. So far, only Massachusetts has a "real exchange."
The Health Data Initiative (HDI) is liberating HHS data as part of the Open Government Initiative. HealthData.gov is the main access point for data and information, with 340 datasetsand tools to date. HHS is sponsoring hackathons and health data forums to bring the research community, data producers, and the technology community together, and it created the NCVHS Working Group on HHS Data Access and Use for the same purpose. No data being made available are identifiable. HHS is looking at de-identification, and has arranged a briefing for the Committee and Working Group on the topic later in this meeting.
Members discussed the HHS work on demographic data. Dr. Cohen predicted that the work on federal standards will help promote other forms of standardization, for example in states. However, he cautioned that people sometimes confuse minimum standards with maximum ones, inhibiting more detailed data collection. He urged the Department to clarify the purpose and nature of the standards and to encourage flexibility in data collection. Dr. Mays commented on the lack of data for some islands and territories and asked about plans to address that gap, such as by offering training. She also expressed concern about behavioral health data collection to monitor the effects of the push to integrate behavioral health and primary care.
Ms. Kloss asked what is being done to capture local experiences in using the data sets in healthdata.gov, and the issues that are arising. Mr. Scanlon acknowledged the importance of evaluation but said not much is happening in this regard yet.
Ms. Daniel began with a report on the standards certification rules that are companions to CMS' meaningful use rules. ONC has worked to provide flexibility so people can adopt only the technology they need to meet meaningful use requirements, along with "glide paths" to help them get to 2014. Regarding privacy and security, ONC has adopted certification criteria that focus on encryption of health information on end-user devices and certification criteria to enable secure messaging between providers and patients and to enable patients to view and transmit their health information. The patient/family engagement piece is core to ONC's consumer engagement efforts. Ms. Daniel also described the work under way on interoperability, data portability, safety and usability (emphasizing user-centered design), and transparency of price and test results.
The second ONC regulatory effort relates to governance of the Nationwide Health Information Network (NHIN), as required in ONC's statute. The goals there are to strengthen interoperability, facilitate the emergence of a market for HIE services, and foster trust. ONC put out a request for information proposing a voluntary governance framework established through regulation, and heard a lot of feedback in response. A strong message was concern that regulations would stifle an emerging market in which a lot is going on. People urged ONC to get more feedback and information from those engaged in this market. They also encouraged the government to have a role, but not necessarily via rules and regulations. ONC has announced that it will not proceed down the regulatory path at present. Rather, it plans a four-pronged approach using available levers, with an emphasis on providing guidance; connecting HIE service providers; and seeking to engage, listen, and learn.
In its consumer program, ONC recently held its second consumer health IT summit. Its pledge program to make data more easily accessible to consumers in electronic form - the Blue Button Pledge Program - now has more than 400 participating organizations. The trademark is now held by HHS, which is working to make the Blue Button more robust and functional.
Finally, Ms. Daniels briefed the Committee on forthcoming hearings of the Health IT Policy and Standards Committees. ONC is creating new workgroups focused on how to use health IT to engage and empower consumers.
Dr. Cohen urged that ONC expand its approach to information access and development of tools and principles for that purpose to include communities' access to and use of aggregated, de-identified information to improve local health.
The co-Chairs explained that this draft letter report by the Subcommittee on Privacy, Confidentiality and Security is designed to support and strengthen community health initiatives by clarifying responsibilities related to stewardship of community data. The most immediate audience for the NCVHS report is the Secretary, and communities are the secondary audiences. The report is modeled on the NCVHS stewardship primer, which is broad in scope.It is intended to frame the major issues and outline guiding principles for communities.
The letter report addresses the issues arising from the practice of reusing data for multiple purposes, or repurposing data. Communities need guidance on how to practice data stewardship so they can preserve public trust and further the positive uses of community data for community benefit. Openness and transparency are basic operating principles.
There was considerable discussion among Committee members, who had reviewed the report prior to the meeting. Dr. Cohen stressed the importance of explicitly defining the relevant "community" in this and other NCVHS documents, and also of clarifying the types of data and data uses in question. Ms. Milam observed that issues can arise from unanticipated actions and consequences; and she noted that the data uses in question fall outside HIPAA coverage. Calling this a quickly-changing landscape, Dr. Mays pointed to forthcoming NIH requirements on community-based participatory research.
The co-Chairs said the Subcommittee would revise the report based on the foregoing discussion and bring it back for review on day two of this meeting.
Dr. Suarez presented a letter based on a June 2012 hearing held by the Subcommittee on Standards, and described the background and key messages. More than 30 testifiers participated in panels on 5010 transactions, operating rules for eligibility and claims status, ICD-10 code sets, dental code sets, and the ACA certification process for health plans. The letter summarizes the common themes across these topics and makes recommendations in each area. A major message to emerge from the hearing was the need for a listening session that could generate a roadmap to help industry comply with regulations by outlining the steps involved. Another theme was the need for collaboration, coordination, openness, and transparency in future standards work and implementation. Other areas are the need for testing; the need to standardize the acknowledgement process; monitoring as a critical activity; and enforcement.
Members discussed the urgent need for an implementation roadmap and testing around ICD-10 code sets, and referred to suggestions in the hearing about innovation in testing methods. Another point flagged for emphasis concerned the needs of the smallest organizations. The letter will be revised and submitted for approval on day two of this meeting.
From the audience, a representative of the American Medical Association thanked NCVHS for past recommendations and, in the present context, called attention to concerns about cash-flow interruptions, especially for small practitioners.
Dr. Carr referred members to the written summary of the Executive Subcommittee retreat, held in August. The purpose of the day-long retreat was to develop an NCVHS roadmap for the next few years. She invited Committee members to discuss two products from the retreat-a set of guiding principles for selecting NCVHS projects, and three overarching and interrelated themes for prioritizing the Committee’s work. These products grew out of the recognition that there are limits to the Committee’s capacities, and it needs to be discerning in its choice of projects.
Members discussed and slightly reorganized the proposed guiding principles, leading to this final version:
As guiding principles, a project under consideration by NCVHS should meet these criteria:
Full Committee members then reviewed and discussed three overarching and interrelated themes that the Executive Subcommittee identified as the organizing framework for the Committee's future work. They crafted the following revised description of the three themes:
Members agreed that the retreat summary document should be revised to reflect these modifications so it can serve as an ongoing planning resource for the Committee.
The Committee focused on what activities and products Theme Three might involve. Mr. Scanlon observed that NCVHS has been successful in crafting visions, and it could help facilitate alignment and convergence among different data streams and uses by devising a vision for the nation's data capacities. Dr. Carr added that the Executive Subcommittee had thought in terms of a finite work product to be completed in a few months. Full Committee members agreed on the wording used above for Theme #3, but did not pursue the idea of a specific near-term work product. There was considerable sentiment throughout this meeting that because the three themes are so interrelated, NCVHS could facilitate convergence and contribute to a unifying framework for the health data infrastructure through its work on the first two themes. Some members suggested that it would take years to craft avision and framework. Ms. Greenberg described the way the NCVHS landmark visions, Information for Health and Shaping a Health Statistics Vision for the 21st Century, evolved through several stages of development, with several interim documents and presentations.
Dr. Carr asked the group to consider whether the three themes are consistent with the new guiding principles, and if so, how they should be operationalized. The first step in this direction, she noted, is the special session on Theme 1 to be held on day two of this meeting. All interested members were encouraged to attend. (See summary below.)
Members expressed support for the guiding principles and themes as "the new way of doing things." There was brief discussion of whether existing subcommittees should continue, with agreement to defer a decision about structure. On Theme One, Dr. Mays suggested that NCVHS focus on the actions the Secretary can take to empower communities. Dr. Walker suggested focusing on the policy frameworks, data structures, and data services that constitute the infrastructure for empowering communities. Members also discussed ways to include more community representation in the Committee's work.
There was further discussion of NCVHS structure and the pros and cons of retaining the subcommittee and Executive Subcommittee structure, with agreement that no structural changes would be made for the time being. Members agreed that the subcommittees "coalesce expertise" in useful ways. Ms. Greenberg pointed out the value of the Executive Subcommittee's leadership; and Mr. Scanlon reminded members of the benefits of continuity for theaudiences for the Committee's work. He also stressed the value, historically and in the future, of providing "proactive thought and ideas" in areas where others are not doing so.
At Dr. Carr's request, all members and lead staff were invited to express their thinking about future directions. With varied nuances, the general view expressed was that the themes and guiding principles are appropriate. The Committee then recessed into breakout sessions, to reconvene the following day.
-- Day Two --
This special session was organized so that interested NCVHS members could explore Theme One of the three themes outlined above -- empowering communities (including individuals and families) to use data to improve their health. Fourteen NCVHS members, including the co-chairs of all four subcommittees, participated, along with a number of staff members. The following summary is organized thematically to capture the major ideas and suggestionsgenerated by their discussion.
Dr. Green began by "anchoring the conversation in the prior work of the Committee" and other entities. He highlighted the NCVHS vision for 21st century health statistics, and especially its schematic on the influences on health; the IOM/ONC work on the learning health system; and the NCVHS project and report on communities as learning systems for health. He noted that communities are mobilizing all across the country to improve local health. Dr. Carr and others observed that this thematic focus is one in which all NCVHS subcommittees can participate.
The remainder of the two-hour discussion focused on ideas for possible projects and cross-cutting suggestions for how to carry them out.
Possible projects
Cross-cutting suggestions (apply to any and all of the above projects)
Purpose:
Conceptualization:
Process:
Project components:
Product(s):
Dr. Carr concluded this special session by expressing appreciation for the quality of the discussion and suggesting that NCVHS use this format of targeted discussions again in the future.
(Full Committee proceedings resume below.)
Following the customary introductions to initiate the full Committee session for day two, Mr. Scanlon reported that Ms. Milam and Dr. Suarez had been reappointed for another term; Dr. Carr and Dr. Warren have completed their tenure on the Committee; Dr. Carr will continue as Chair of the Working Group on HHS Data Access and Use; and the Secretary has appointed Dr. Green as the next NCVHS Chair.
Ms. Greenberg added that the appointments of four new members are in process, and they are expected to join NCVHS in time for the November meeting.
Dr. Carr offered words of advice to NCVHS members and Dr. Green, based on her experience as a member and Chair. In conclusion, she enjoined everyone to "recognize the honor bestowed" on them and to "live up to it."
Dr. Suarez noted that the approach to this letter reflects Dr. Carr’s influence regarding being explicit about the reasons for a project/letter, who is affected by it, and its intended benefits. He then presented the letter that was discussed the previous day and revised accordingly. After a few minor changes, the Committee passed a motion approving the letter, as revised.
He then conveyed the recommendation of the Subcommittee on Standards that NCVHS wait until next year to produce its next report to Congress on HIPAA implementation, because its 10th report was submitted relatively recently and is still timely, and many new developments are anticipated in the coming year. Dr. Carr and NCVHS members agreed with this recommendation. She acknowledged the extraordinary leadership and hard work of the Subcommittee's co-Chairs.
Ms. Kloss presented a draft of this letter-report, which was revised based on the previous day's discussion. The document is intended to inform the Secretary about an emerging issue. Ms. Kloss and Dr. Francis noted the possibility that this new activity will lead to a revision of the NCVHS primer on data stewardship, published in 2009.
They then explained the revisions to the letter-report, and discussed the new draft with the Committee. The discussion had these major points: the need for universal protection and universal application of stewardship principles across diverse communities; the critical role of the data steward; and the notion that "accountable reuse" requires transparency and openness.
The Subcommittee on Privacy, Confidentiality and Security was asked to revise the letter further to more fully explain its context and key concepts. The next draft will be circulated to the full Committee, revised further as needed, and reviewed by the Executive Subcommittee in preparation for the November full Committee meeting.
Dr. Green laid out the steps that follow from the morning's session on empowering communities: producing a summary of the discussion, clarifying the federal players who should be involved, and getting clear about preciselywhat space needs to be "stepped into" by NCVHS. (Mr. Scanlon suggested also looking at the resources CDC has produced on community health, and possibly doing an environmental scan.) Further, Dr. Green asked staff for a management approach for NCVHS, noted the need to tighten up staffing, and expressed hope that new members can be thoroughly oriented in advance of the next meeting. As part of his personal remarks and suggestions to members, he pointed to the rapidity and extent of the change under way, and the Committee's opportunity to remedy the missing infrastructure for community data use and action.
Dr. Green announced that Dr. Cohen would serve as the new co-chair of the Subcommittee on Population Health. Ms. Greenberg said that apart from that change and Dr. Green's Chairmanship, the Executive Subcommittee would remain the same as before. The group briefly discussed plans for November 15, including a Subcommittee on Standards roundtable discussion and a possible working session on one or two of the new themes.
Heritage is an integrated physicians' network in 35 locations in Southern California. As a fully capitated medical group, it is at risk for both professional and hospital claims, making it essential to control hospital costs and reduce unnecessary hospital utilization. It stratifies its population for that purpose and uses various case management techniques, which Mr. Gluck briefly described. Heritage created the Heritage Health Prize (which he manages along with serving as the network’s General Counsel) to predict hospitalization and identify members who would benefit from preventive measures in a "real-world-usable" manner. This he characterized as part of a general attempt by the network to move from a "post-disease provision-and-care model to a predisease prediction, prevention and cure model."
Privacy issues drove many decisions about the structure of the Heritage Health Prize. It was necessary to ensure that the data released to prize participants were de-identified and could not be re-identified, and Heritage contracted with Dr. El Emam to de-identify the data. (See his presentation below.) Although using rich data could produce the best solution, it was necessary to pull back data to prevent re-identification. Heritage used technical and legal methods to manage this risk, including having entrants click on a "terms of use" form that prohibits re-identification attack. Besides creating a strict legal structure around data release to prize participants, Heritage commissioned an adversarial attack on the data to determine if de-identification was stringent enough. The conclusion was that "it would be extremely difficult to re-identify the Heritage Prize data."
Mr. Gluck noted the benefits of holding a competition like this instead of "hiring five people and having them try to solve the problem," because "you don't know where your best solution is going to come from." Indeed, most of the leading solutions are coming from people outside the medical field, he said. He concluded by citing society's need to balance individual privacy interests with the greater social good to be achieved by solving large problems through crowd sourcing.
Dr. El Emam then described the de-identification methods used, the technical issues his team faced, and the lessons they have already identified. He noted that de-identification is a very active area of research. He observed that re-identification attacks are hard to do and take a lot of skills and resources; and if a data set is de-identified properly, the probability of a successful re-identification attack is low. He explained their approach to passing the "reasonableness test" in HIPAA, and said that in general, they erred on the conservative side. For example, patients with sensitive data were removed from the data set, and Heritage chose not to include lab or drug data because they increased the possibility of re-identification. He added that the concept of adversary power and patient diversity were very important.
Summarizing the lessons learned thus far, he said that they now tend to use average risk rather than maximum risk for data releases. In addition, over the last 18 months they have developed efficient algorithms for assessing adversarial power that provide a strong quantitative basis for allowing the release of more longitudinal data.
Mr. Gluck said he would share with NCVHS a copy of the contract with prize participants. To other questions, he said the data do not include any address information; participants are allowed to use publicly available data sets as well; and once the contest is over, Heritage will not be able to track future re-identification attempts using the data. The contest ends in mid-2013. Mr. Quinn commented that NIST might be able to provide technical guidance on de-identification and re-identification in a joint project with HHS.
With this, Dr. Carr adjourned the full Committee meeting.
I hereby certify that, to the best of my knowledge, the foregoing
summary of minutes is accurate and complete
/s/ 11/14/ 2012
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Chairperson Date