Department of Health and Human Services

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

June 15-16, 2011

Doubletree Hotel, Arlington, VA

Meeting Minutes

The National Committee on Vital and Health Statistics was convened on June 15-16, 2011, at the Doubletree Hotel in Arlington, VA. The meeting was open to the public.

Present:

Committee members:

(*new members)

  • Justine M. Carr, M.D., Chair
  • John J. Burke, MBA, MSPharm.*
  • Raj Chanderraj, MD, FACC*
  • Bruce Cohen, Ph.D.*
  • Leslie Pickering Francis, J.D., Ph.D.
  • Larry A. Green, M.D.
  • Mark Hornbrook, Ph.D.
  • Linda Kloss, RHIA, CAE, FAHIMA*
  • Vickie Mays, Ph.D., MSPH*
  • Blackford Middleton, M.D., MPH, MSc
  • Sallie Milam, J.D., CIPP/G
  • Len Nichols, Ph.D.*
  • William J. Scanlon, Ph.D.
  • W. Ob. Soonthornsima*
  • Walter Suarez, M.D.
  • Judith Warren, Ph.D., R.N.

Outgoing members

  • J. Marc Overhage, M.D., Ph.D.
  • Donald M. Steinwachs, Ph.D.

Absent:

  • Paul Tang, M.D.
  • James Walker, M.D., FACP*

Lead Staff and Liaisons

  • Marjorie Greenberg, NCHS, Exec. Secretary
  • James Scanlon, ASPE, Exec. Staff Director
  • J. Michael Fitzmaurice, AHRQ liaison
  • Charles Friedman, Ph.D., ONC liasion

Others

  • Debbie Jackson, NCHS
  • Katherine Jones, NCHS
  • Marietta Squire, NCHS
  • Bill Allano, BlueCross BlueShield Assn. (BCBS)
  • Michael DeCarlo, BCBS Assn.
  • Cathy Sheppard, ASC X12
  • Cynthia Wark, AHIP
  • Thomas Bizarro, First DataBank
  • Maria Friedman
  • Allison Viola, AHIMA
  • Frank Kyle, Amer. Dental Assn.
  • Steven Lazarus, Boundary Info. Grp
  • Margaret Walker, HP
  • Peter Barto, PWC
  • Dan Rode, AHIMA
  • Denise Love, NAHDO
  • Emily Sullivan, NAHDO
  • Patrick Miller, APCD Council
  • Alan Prysuyka, ME Health Data Org.
  • Craig Schneider, MA Health Data Consortium
  • Keely Cofrin Allen, Utah DOH

Note: The transcript of this meeting and speakers’ slides are posted on the NCVHS Web site, http://ncvhs.hhs.gov. Use the meeting date to locate them. For final versions of NCVHS documents discussed in the meeting, see “Reports and Recommendations.”

EXECUTIVE SUMMARY

The meeting began with a remembrance of former NCVHS member Barbara Starfield, M.D., who died recently. Dr. Starfield was internationally respected and valued for her contributions to the field of primary care, and she will be missed by her NCVHS colleagues.

Updates from the Department–Jim Scanlon, ASPE

Mr. Scanlon reviewed the HHS Strategic Plan and discussed two HHS data initiatives. To implement the Affordable Care Act (ACA), HHS is working on what types of data are needed to monitor implementation and outcomes, and identifying potential data sources. This includes trying to closely monitor insurance coverage and the impacts of the lack thereof. The Department’s Health Data Initiative is “liberating” data for use by local communities,app developers, and others. It is an HHS goal to improve access to community-level data that people can use for local decision making. The Department plans to add granularity to the demographic information in survey data.

ONC Update: The Learning Health System–Dr. Friedman, ONC (slides)

Dr. Friedman focused updating the Committee on the Learning Health System (LHS), a joint project of ONC and the IOM. He showed a schematic of the LHS and noted that to function it will need governance; public/patient engagement and trust (“above all”); technical functions such as the ability to aggregate and analyze data; and knowledge dissemination to points of care, research, and decision. Meaningful Use is a necessary but not sufficient precondition of the LHS: While meaningful use is achieved individually by professionals and hospitals, the LHS is a system that binds them together in a way that enables them jointly to achieve goals. In other words, “meaningful use, plus some delta, is what will be required to achieve a learning health system.” ONC and the IOM co-hosted three workshops on the LHS, resulting in a report released on May 23.

Update on Privacy and Security Activities–Joy Pritts, JD, Chief Privacy Officer, ONC (slides)

Ms. Pritts gave a brief overview of her role and mandate, and then described current activities of the HIT Policy Committee’s Tiger Team on privacy-related policy issues, including provider authentication, accreditation and credentialing. The HIT Standards Committee has been working on digital certificates and will be working on patient information matching. ONC has set up a process for processing and responding to federal advisory committee recommendations that come through ONC.

Review of NCVHS Roadmap Targets?Dr. Carr

Dr. Carr gave an overview of NCVHS priorities and plans for the next 18 to 24 months. She reviewed the external factors and past NCVHS visions with which the Committee’s new plans must align, and outlined the major work areas before the Committee.

PCAST Letter Review–Dr. Carr

Dr. Carr led a discussion of a draft letter to the Secretary containing NCVHS recommendations for achieving the goals of the PCAST Report on Health Information Technology. The NCVHS letter is structured around a series of observations, each followed by one or more recommendations. Work on this letter continued throughout the meeting and afterwards. The final version of the letter was approved on August 26, and is posted on the NCVHS website.

Standards Update–Dr. Suarez (slides)

Dr. Suarez presented an overview of NCVHS work, past and planned, on administrative simplification and health reform. The Subcommittee’s administrative simplification tasks include the following: unique health plan identifier, eligibility and claim status operating rules, EFT and ERA, acknowledgements, and improvements to national process for standards/operating rules development and adoption, plus regular reports to Congress on HIPAA implementation. Operating rules–the “third leg” of administrative simplification, along with the standards and implementation specifications,–are a current Subcommittee focus. It has developed work timelines that extend through 2016.

Briefing on Privacy/Populations May 12 Workshop–Dr. Francis, Ms. Milam, Dr. Green

The Privacy and Populations subcommittees co-hosted workshops in February and May. The first explored how communities are innovatively using data to improve local health and what they need to accomplish more; the second focused in on privacy and security challenges and how communities can establish trust around data use, with transparency and community involvement as important strategies. At the February workshop, the community representatives said they need more granular data and help with analytics. The need for a stronger population health information infrastructure was evident. Dr. Green described this phenomenon as an emerging organic processgoing on from coast to coast at the community level, where people are applying information to improve local health. The question for NCVHS is how to help facilitate it and, in particular, what are the implications for federal policy. Summaries of both sessions are posted on the NCVHS website.

Tenth HIPAA Report to Congress–Drs. Suarez and Warren

Dr. Suarez noted that the tenth anniversary of NCVHS HIPAA reports is an opportunity to re-view where things are and where things are going. He referred members to a high-level outline for the intended report to Congress, which is required of NCVHS every year. A draft of the report is expected later in June, which the Subcommittee on Standards will continue to work on in conjunction with the Subcommittee on Privacy, Confidentiality and Security. A draft will be presented to the full Committee in September, with a final report slated for review and approval in November. The group agreed that the report should include small sections on quality and population health as well as privacy and standards.

Members discussed a number of ideas for spin-offs from the HIPAA report (see detailed summary), notably work on the data needs that underlie payment reform, as well as new ways to share the Committee’s thoughts on HIPAA’s contributions with industry and with community members.

Findings and Directions from Acknowledgments and Standards Process Hearing–Dr. Suarez

Acknowledgement transactions are one of the areas about which NCVHS makes recommendations, and the Subcommittee has begun a letter based on the findings from an NCVHS hearing held in April, 2011. The transactions are designed to reduce the need for other forms of communication and to increase efficiency, although use is voluntary, which represents a barrier. The April hearing revealed a sense of urgency about having these transactions in place quickly. The Subcommittee will present its draft letter to the full Committee in September.

Multi-Payer Claims Database (MPCD) for Comparative Effectiveness Research–Andre Chappel, Ph.D., ASPE (slides)

The Secretary was advised to use funding from the American Recovery and Reinvestment Act of 2009 for improving comparative effectiveness research (CER) to focus on infrastructure development, and HHS decided to create a database combining claims data from public and private payers–a multi-payer claims database (MPCD). The highest goal for it is protecting the privacy of the patient data in the database. Within that, the goal is to enable research on priority populations, interventions, and conditions for both clinical and delivery system research, with analytic tools for greater functionality. The ultimate aim of this public-private partnership is to lay thefoundation for future enhancements with clinical data. Dr. Chappel reviewed the development and nature of the project. The key partners are AcademyHealth, NAHDO, Buccaneer Computer Systems and Services, and the University of Washington.

In a brief discussion period, NCVHS members raised points about using these data for the Mini-Sentinel Surveillance; ownership of the data and the infrastructure; privacy protections and mapping for the chain of secondary uses; potential benefits in terms of evaluating population health and conducting surveillance; states’ ability to use the database; the difference between “all-” and “multi-” payer databases; the limitations of claims data; and the potential role of NCVHS in this project.

All-Payer Claims Databases: State Progress and Federal Integration–Denise Love, NAHDO (slides)

All-Payer Claims Databases (APCDs) are typically created by state mandate and include claims data from medical, pharmacy, and often dental plus eligibility and provider files from public and private payers. A big driver in terms of purpose is transparency. The “whole idea” is to build a population-based dataset to look at health care delivery performance and the health of the state’s population. Since APCDs began in the early 2000s, a proliferation of initiatives (e.g., payment reform, HITECH and ACA) has made them more urgent. Ms. Love showed a map of the states with existing databases, those in an early implementation stage, and those in a planning stage. She characterized usage of the databases as “something for everyone” including consumers, providers, employers, researchers, and state government (including for public health purposes); and she showed illustrative usecases.

The APCD Council and NAHDO are spending much of their time helping states put together data policies, regulations, and laws for an APCD. Its Technical Advisory Panel was funded by AHRQ to develop core standards and data elements. NAHDO also helps states with governance models. Funding is the major roadblock, and NAHDO hopes to help states cobble together funding; NAHDO also helps with the technical build. Finally, Ms. Love commented on lessons learned thus far and the challenges facing states.

In response to query about a possible NCVHS role, Patrick Miller of the University of NH, co-chair of the APCD Council, said the Council would like to work with the Committee. Dr. Francis pointed out the need to ensure trust, and Dr. Suarez reiterated the need to elevate this issue and to have a strong, guiding privacy and confidentiality framework. Ms. Greenberg added the importance of transparency and education. Everyone affirmed that this is the beginning of a dialogue, and Dr. Carr stressed the Committee’s interest in this project.

Subcommittee Reports, Strategic Plans and Next Steps

(See the brief summaries at end of the summary below.)

DETAILED SUMMARY

– Day One –

Welcome, Introductions; Remembrance of Dr. Barbara Starfield

Following introductions and a welcome to new members, at Dr. Carr’s request, Dr. Green spoke in memory of former NCVHS member Barbara Starfield, M.D. Dr. Starfield made major contributions to the field of primary care, which she viewed as “medicine’s way of improving population health and relieving disparities.” She was respected and is grieved all over the world, and will be missed by her NCVHS colleagues.

Updates from the Department―Jim Scanlon, ASPE

Mr. Scanlon reviewed the HHS Strategic Plan, which the Department published about two years ago and will soon update. It has five goals that express the Department’s priorities. To implement the Affordable Care Act (ACA), HHS is working on what types of data are needed to monitor implementation and outcomes, and identifying potential data sources. He called the Committee’s attention to Section 4302 of the ACA on Data Collection Standards, which specifies the minimum demographic data expected in all surveys. Much (but not all) of the information is already in surveys, with provisions for asking questions in the person’s native language. However, the Department plans to recommend additional granularity as a basic standard for most HHS programs. Income and education will likely be included. This will probably affect Census Bureau surveys, as well. The recommended changes will be posted on the HHS website and sent to NCVHS members, followed by a comment period.

The Department’s Health Data Initiative is working on improving access to HHS data as part of the Open Government plan. It has posted more than 200 data sets on healthdata.gov. No identifiable data are released. The “data liberation” initiative is related to an effort to stimulate web technology developers to develop new applications, particularly ones with beneficial local uses. HHS and IOM have jointly held two successful forums wherenew applications were demonstrated.

On the budget, Mr. Scanlon said core statistical activities have held constant in the 2011 budget, despite some cuts in other areas. In addition to developing additional data to monitor the impact of health reform, HHS isalso trying to closely monitor insurance coverage and lack thereof, including the impacts of state cutbacks in Medicaid eligibility.

Dr. Green asked about the need for more and better local data, and Mr. Scanlon said it is an HHS goal to improve access to community-level data that people can use for local decision making. He added that this is all the more pressing in a declining economy, with its negative health consequences.

Dr. Francis said there were disappointingly few community-oriented applications shown at the June 9 IOM/HHS data forum. Ms. Greenberg observed, though, that Dr. Sondik hosted a session on local information needs, attendedby several NCVHS members. Some of the demoed apps recognize the range of influences on health (as shown in the graphic on health determinants in the Committee’s vision for 21st century health statistics)?e.g., showingthe locations of full-service grocery stores.

ONC Update: The Learning Health System?Dr. Friedman, ONC (slides)

In his last appearance before NCVHS as the Chief Scientific Officer of ONC, Dr. Friedman focused on an update on the Learning Health System, a joint project of ONC and IOM. IOM defines the learning health system (LHS) as “one in which progress in science, informatics, and care culture align to generate new knowledge as an ongoing, natural by-product of the care experience, and seamlessly refine and deliver best practices for continuous improvement in health and health care.” This is an outgrowth of a progressive and continuous federal vision over more than a decade. A LHS can greatly shorten the time it takes to respond to given problems, such as adverse drug reactions or epidemics. The LHS is a pillar of the forthcoming Health IT Strategic Plan, and is explicit or implicit in four of its five goals. Dr. Friedman showed a schematic of the LHS in the U.S., noting that to function it will need governance; public/patient engagement and trust (“above all”); technical functions such as the ability to aggregate and analyze data; and knowledge dissemination to points of care, research, and decision.

ONC and the IOM co-hosted three workshops on the LHS, resulting in a report released on May 23. One of its creative ideas is the concept of the LHS as an ultra large-scale system that functions the way the Internet functions today. Meaningful Use is a necessary but not sufficient precondition of the LHS: While meaningful use is achieved individually by professionals and hospitals, the LHS is a system that binds them together in a way that enables them jointly to achieve goals. In other words, “meaningful use, plus some delta, is what will be required to achieve a learning health system.”

The LHS as currently envisioned will be a federation of some type (not a centralized database), grounded in public trust and patient engagement, with participatory governance and “just enough” standardization. The “grand strategy” to achieve this vision involves simultaneously building toward national meaningful use, building the “delta,” and doing each in a way that anticipates the other. The Federal LHS Working Group has seven projects in four agencies (including the multi-payer claims database described below), and is exploring whether they could join to form an LHS using shared technology and policies. In addition, a new IOM study (nicknamed the “sushi-grade data study”) is looking at what levels of data quality are needed for different types of learning; and ONC’s standards and operability framework is generating a “lightweight initial approach” to asking a questionacross a distributed network.

Discussion

Members talked with Dr. Friedman about the potential role of administrative data; the lack of uniformity in privacy and security mechanisms; and technical and legal issues associated with clinical decision support and knowledge management.

Asked about NIH’s response to all this, Dr. Kaplan, the new NIH liaison, said he hopes to expand what NIH is doing in these areas. An NIH working group will be looking at information issues as part of an effort to expand NIH research activities in primary care. Dr. Friedman added that the Genome Institute recently generated some things deserving of attention, related to standards and interoperability.

Dr. Hornbrook urged that scenarios be developed that the general public can understand, related to what the learning health system would mean for them.

Dr. Suarez thanked Dr. Friedman on behalf of the Committee for his service and contributions to ONC and as liaison to NCVHS. This was echoed by Dr. Carr and other NCVHS members and staff.

Update on Privacy and Security Activities–Joy Pritts, JD, Chief Privacy Officer, ONC (slides)

Ms. Pritts gave a brief overview of her role and mandate, and then described some of her current activities around what she called “big-P policy issues” related to privacy. The Policy Committee’s privacy and security workgroup, The Tiger Team, has been addressing key privacy and security issues including provider authentication. The Team’s original recommendations, which Ms. Pritts described, called for an accreditation program and credentialing to help prevent fraud; they were revised at the request of the Standards Committee. The revised recommendations on certificate authorities, accepted by the Policy Committee, have proved to be controversial. The Standards Committee has issued recommendations on digital certificates.

The Policy Committee is working on several other areas related to privacy and security, including how to build them into Meaningful Use activities in stages 1 and 2. They will focus on encryption in Stage 2. The Tiger Team will focus on a more comprehensive security framework in light of evolving technology, including filling in gaps in the HIPAA Privacy Rule and the Security Rule. T he Tiger Team has been focusing on patient information matching, which has now shifted to the Standards Committee.

Ms. Pritts then touched on the HITECH modifications to the HIPAA Privacy Rule, activities around privacy issues in the ACA, and efforts on Capitol Hill to get a bill passed providing baseline federal information privacy. Finally, she said that ONC has set up a process for processing and responding to the recommendations of federal advisory committees that come through ONC.

Review of NCVHS Roadmap Targets–Dr. Carr

Dr. Carr introduced a discussion of NCVHS priorities and plans for the next 18 to 24 months. Planning needs to align with the NCVHS charter, guiding NCVHS visions, national priorities and legislative mandates, emerging issues in health and health care, and the resources and timeframes of NCVHS members and meetings. The richness of the Committee, she noted, comes from the intersection of experts in a range of fields and from the issue identification that arises at this intersection. She reviewed the work before the Committee, including commenting on the PCAST Report, moving ahead with the findings from the February and May workshops on community health, and carrying out ACA assignments. She concluded by outlining the tasks be-fore the Committee at the present meeting, and encouraging new members to attend and join subcommittees.

Dr. Middleton pointed out that the NCVHS charter applies not only to information and data but to knowledge, and the focus on the learning health system will lead to further work on knowledge management. Dr. Burke wonderedif the Committee would also look at cost issues. Ms. Greenberg commented on the Committee’s growing interest in recent years in communi-cating more broadly with the public and educating people about the issues it works on.

PCAST Letter Review–Dr. Carr

Dr. Carr led a discussion of a draft letter to the Secretary containing NCVHS recommendations for achieving the goals of the PCAST Report on Health Information Technology. The NCVHS letter is structured around a series ofobservations, each followed by one or more recommenda-tions. See the transcript for details of the discussion, starting on page 71.

The group began by discussing the key messages in the NCVHS letter, which begins by outlining the concepts in the PCAST Report that align with NCVHS priorities. A theme throughout the discussion of the letter was the importance, in many areas addressed by the PCAST Report, of building on and maintaining continuity with current work that is taking place at national, regional, and local levels, while also facilitating transformation. In part, the NCVHS letter cautions against unintended consequences and the need to “manage the delta.” In particular, the Commit-tee wants to call attention to issues related to privacy and standards, as well as stressing the central purpose of improving the quality of health care and health.

(Members and staff continued to work on this letter after the meeting, then again on day two, and in the weeks following the meeting. The final version of the letter was approved on August 26, and is posted on the NCVHS website.)

Standards Update–Dr. Suarez (slides)

Dr. Suarez presented an overview of NCVHS work, past and planned, on administrative simplification and health reform. (See transcript for details.) He began with a look at the regulatory landscape, which he characterizedas “a persistent storm” with four things (HIPAA 1 and 2, Meaningful Use standards, 2010 health reform, and a set of changes from the states and others) coming together over the next three to four years. He showed a timeline that pulls together all the HIPAA and Meaningful Use requirements between 2011 and 2015.

He then outlined the assignments within health reform related to administrative simplification and standards (Sections 1104 and 10109), and showed a timeline for them that goes to 2016. The ACA calls for a crosswalk from ICD-9-CM to ICD-10 code sets as an official code set under HIPAA regulation, and establishes a monitoring function that NCVHS can perform.

Operating rules are the “third leg” of administrative simplification, along with the standards and implementation specifications, and they are the most significant portion of Section 1104. Dr. Suarez explained what they are and their intended benefits. The ACA defines them as “the necessary business rules and guidelines for the electronic exchange of information that are not defined by a standard or its implementation specification….” NCVHSis responsible under ACA for selecting and informing HHS on 1) the entity/entities selected to be operating rules authoring organizations, and 2) the operating rules to be adopted for HIPAA transactions.

Finally, Dr. Suarez reviewed the status of NCVHS work on the following administrative simplification tasks: unique health plan identifier, eligibility and claim status operating rules, EFT and ERA, acknowledgements, and improvements to national process for standards/operating rules development and adoption. He outlined the Subcommittee on Standards’ work plans for 2011 and 2012, which include a series of hearings in addition to issuing the Tenth and Eleventh HIPAA Reports to Congress.

Dr. Carr’s response was, “It is incredible, it’s extraordinary…and it’s intimidating.” She praised the Subcommittee on Standards for mastering this complex content and doing the formidable amount of work involved.

Briefing on Privacy/Populations May 12 Workshop–Dr. Francis, Ms. Milam, Dr. Green

Dr. Francis reported that the Privacy and Populations subcommittees co-hosted workshops in February and May. The first explored how communities are innovatively using data to improve local health and what they need to accomplish more; the second focused in on privacy and secu-rity challenges and how communities can establish trust around data use and prevent what Denise Love of NAHDO called a “lockbox mentality.” Transparency and community involvement are important strategies. Summaries of both sessions are posted on the NCVHS website.

Regarding the February workshop, Ms. Milam and Dr. Green reported that the community representatives said they need more granular data and help with analytics. The need for a stronger population health information infrastructure was evident. Dr. Green described this phenomenon as an emerging organic process going on from coast to coast at the community level, where people are applying information to improve local health. He stressed the need for an infrastructure to support the efforts to improve community health, which currently are being conducted with very limited resources. He concluded, “Something is trying to happen here.” The question for NCVHS is how to help facilitate it and, in particular, what are the implications for federal policy.

Before recessing into breakout sessions, the chairs of each of the subcommittees put in a pitch to new members to consider membership in their groups. Ms. Greenberg added that NCVHS also has many crosscutting activities, and efforts are made to keep members abreast of the work of all subcommittees.

-Day Two-

Dr. Carr began by acknowledging the “superb support” of NCVHS Team members ?Debbie Jackson, Marietta Squire, Katherine Jones, and Jeannine Christiani Mtui.

Ms. Greenberg noted that Dr. Don Steinwachs and Dr. Marc Overhage had been “welcomed into the NCVHS Alumni Association,” upon their retirement from the Committee. They were honored at a Committee dinner the previous evening.

PCAST Letter (as revised)

After describing the changes made to the draft PCAST letter, Dr. Carr read the revised letter and led a discussion of it. The Committee discussed the draft letter in considerable detail, and again referred it to a small group for further editing. Dr. Carr noted that this has been the Committee’s first opportunity to discuss the PCAST Report and NCVHS response face to face.

As noted above, work on this letter continued after the meeting. The final version was approved on August 26 and is posted on the NCVHS website.

Tenth HIPAA Report to Congress (Outline, Process, and Progress)–Drs. Suarez and Warren

Dr. Suarez noted that the tenth anniversary of NCVHS HIPAA reports is an opportunity to review where things are and where things are going. The timing coincides with transition to a new version of the standards and to ICD-10 code sets, representing a “new step in the journey of ad-ministrative simplification.” He referred members to a high-level outline for the intended report to Congress. The report is required of NCVHS every year. A draft of the report is expected later in June, which the Subcommittee on Standards will continue to work on in conjunction with the Subcommittee on Privacy, Confidentiality and Security. A draft will be presented to the fullCommittee in September, with a final report slated for review and approval in November.

The group agreed that the report should include small sections on quality and population health as well as privacy and standards. Dr. Middleton offered to contribute a “quality dimension” to the HIPAA report. Dr. Nicholspointed out the future significance of claims adjudication for ad-ministrative simplification.

In a wide-ranging discussion, members raised a number of issues. Dr. Kloss suggested finding ways to communicate the high points of the report to the industry, reflecting on what has been accomplished. Dr. Green noted the silence about the fundamental flaws in health care financing, which undermine the things administrative simplification is designed to achieve. While several members expressed support for this concern, the general sentiment was that the NCVHS HIPAA report is not the appropriate vehicle for conveying this message. Also, if NCVHS wants to ad-dress health care financing issues, it will need to do so within the scope of its charge. Dr. Scanlon stressed the strong link between wanting payment reform and having the data to support it; he urged thinking strategically about what information is needed to inform payment reform decisions, and how to get it. The process could begin, he said, with preliminary language about what is possible and desirable. Dr. Cohen noted that there are both short-term and long-term data needs, and the Committee needs to reflect on both and consider including both dimensions in the HIPAA report (and/or in other documents).

Ms. Greenberg reflected on the ways in which HIPAA has stimulated a “bringing-together of communities,” such as Medicaid agencies and public health entities, toward greater standardiza-tion around common needs. She noted the possibility of a more “omnibus” report marking the tenth NCVHS HIPAA report, perhaps extracting a shorter document for Congress. Responding to Dr. Kloss’ suggestion about communicating with industry, she noted that NCVHScould generate multiple small documents for targeted audiences, and its website could become more of a resource center. Dr. Mays suggested producing a brief statement about “what’s good for the community about HIPAA,” to help bring the community along. This led to further reflections on the positive impact of HIPAA and the way researchers and others had learned to work within it.

Dr. Warren pointed out the original intent of HIPAA reports and suggested that a “second report” pull together the issues and ideas raised in the foregoing discussion. Such a report could also address the impact of post-HIPAA legislation (HITECH, ACA, etc.) on data requirements and opportunities, and look ahead to the future. Dr. Carr suggested that all subcommittees keep this idea in mind as they plan future work. She also asked themto think about what they want to say about HIPAA in the forthcoming report.

Findings and Directions from Acknowledgments and Standards Process Hearing–Dr. Suarez

Dr. Suarez reminded his colleagues that acknowledgements is one area on which NCVHS makes recommendations, and the Subcommittee has begun a letter based on findings from an NCVHS hearing held in April, 2011. He explained the key concepts around acknowledgements, a new type of transaction under HIPAA that communicates the status of a transaction between trading parties. The transaction is designed to reduce the need for other forms of communication and to increase efficiency, although use is voluntary, which represents a barrier. Three critical types of acknowledgement are the TA1, 999 implementation acknowledgement, and 277CA health care claim acknowledgement. Dr. Suarez outlined the major findings from the April hearing, which revealed a sense of urgency about having these transactions in place quickly. On this basis, the Subcommittee plans to recommend that theSecretary adopt these three as HIPAA transactions using an expedited NPRM process, exclude pharmacy transactions conducted in real time, make clear the conditions for submission of each acknowledgment transaction, and other actions. The Subcommittee will present its draft letter to the full Committee in September.

Multi-Payer Claims Database (MPCD) for Comparative Effectiveness Research ?Andre Chappel, Ph.D., ASPE (slides)

This project began with funding from the American Recovery and Reinvestment Act of 2009 to improve comparative effectiveness research (CER). The Secretary was advised to focus on infra-structure development for CER, and HHS decided to create a database combining claims data from public and private payers?a multi-payer claims database (MPCD). The highest goal for it is privacy protection for the patient data in the database. Within that, the goal is to enable research on priority populations, interventions, and conditions for both clinical and delivery system research, with analytic tools for greater functionality. The ultimate aim of this public-private partnership is to lay the foundation for future enhancements with clinical data. Incorporating public and private data into a single source is expected to enhance the value of claims data for CER.

Dr. Chappel reviewed the development and nature of the project, which has had two design pilots thus far. (See slides for further details.) The contract for implementing the MPCD in Phase 2 was awarded to Ingenix (now OptumInsight), which is collaborating with ASPE and CMS and consulting with health care leaders. The databases will have both a centralized data repository and a distributed data network. The two initial data sources are the CMS Chronic Condition Warehouse and Ingenix’ Normative Health Information (NHI) database. Efforts are under way to add two other data sources. The project has a governance board and an HHS Leadership Council as governance. A Data Stewardship Council will include all data contributors and provide an arena to voice concerns and ensure that data requests meet the criteria. An HHS Expert Panel composed of HHS researchers will utilize and test the system beginning in February 2012 and give feedback on improving it.

The efforts to ensure privacy and security along with usability include testing enclave models. The data access model has three tiers of access?a public use file with aggregated data only, a standard analytic file representing a 5-10 percent extract, and full claims files. There are criteria for evaluating data partners as well as incentives for their participation. The key partners in the project are AcademyHealth, NAHDO, Buccaneer Computer Systems and Services, and the University of Washington. The project is building awareness and demonstrating MPCD utility through presentations to agencies and at conferences and articles in peer reviewed journals. Future plans include incorporating value-added analytics and non-claims data.

In a brief discussion period, NCVHS members raised points about using these data for the Mini-Sentinel Surveillance; ownership of the data and the infrastructure; privacy protections and map-ping for the chain of secondaryuses; potential benefits in terms of evaluating population health and conducting surveillance; states’ ability to use the database; the difference between “all-” and “multi-” payer databases; the limitations of claims data; and the potential role of NCVHS in this project.

All-Payer Claims Databases: State Progress and Federal Integration–denise Love, NAHDO (slides)

Ms. Love said All-Payer Claims Databases (APCDs) are emerging quickly, and she introduced six members of the NAHDO board and APCD data stewards who were present in the audience. These large-scale databases are typically created by state mandate and include claims data from medical, pharmacy, and often dental plus eligibility and provider files from public and private payers. Medicare and Medicaid are either in or “an active, planned part” of state data systems. APCDs are enhancing and supplementing but not replacing hospital discharge data, Medicare, registries, and other datasets. A big driver in terms of purpose is transparency. The “whole idea” is to build a population-based dataset to look at health care delivery performance and the health of the state’s population.

The sources (or potential sources) of APCD data fall into four groups, based on how they are coming on line: 1) commercial, TPAs, PBM, dental, and Medicare parts C&D claims; 2) Medi-caid FFS, managed care, and SCHIP claims; 3) Medicare parts A&B claims; and 4) uninsured, Tricare, VA, HIS, and FEHB claims. (See slides for details.) Many states are getting encrypted or de-identified social security along with patient demographics. Since APCDs began in the early 2000s, a proliferation of initiatives (e.g., payment reform, HITECH and ACA) has made them more urgent. States are seeking a dashboard they can use to manage the new initiatives. Ms. Love showed a map of the states with existing databases, those in an early implementation stage, and those in a planning stage. In Washington and Wisconsin, employer coalitions (rather than a state mandate) took the first steps. States without a legislative mandate have more flexibility but cannot compel reporting, and volunteer initiatives such as these are providing useful information.

Ms. Love characterized usage of the databases as “something for everyone” including consumers, providers, employers, researchers, and state government (including for public health purposes). She showed illustrative use cases (see slides) related to such topics as the prevalence of selected conditions, comparisons of prevalence between public and commercial insurance populations, cost comparisons for specific surgeries by hospital, and episode of care groupings.

The APCD Council and NAHDO are spending much of their time helping states put together data policies, regulations, and laws for an APCD. Its Technical Advisory Panel was funded by AHRQ to develop core standards and data elements. NAHDO also helps states with governance models. Funding is the major roadblock, which is ironic, since states need this resource now more than ever to make cost-effective decisions about how to use limited resources. NAHDO hopes to help states cobble together funding; and it helps with the technical build.

On linkages, Ms. Love said the APCD can help effect strategic, just-in-time linkages, perhaps with a state linkage review board reviewing requests. She outlined the vision for “APCD version 2.0” and commented on lessons learned thus far and the challenges facing states, which include standardization and identification issues, the completeness of populations captured, the sheer work involved at start-up, and many others. Maintenance will be another challenge going forward.

Discussion

NCVHS members had a number of questions and comments (some of which are noted here). Dr. Nichols commented on the need for national messaging and asked what kind of help with stand-ardization efforts is needed from federal government and other stakeholders. Patrick Miller of the University of NH, co-chair of the APCD Council, described standardization efforts thus far. He noted the need for external stakeholders from the plans to prodand support the standards movement. In response to query about a possible NCVHS role, he said the Council would like to work with the Committee. Dr. Francis pointed out the need to ensure trust, and Dr. Suarez then reiterated the need to elevate this issue and to have a strong, guiding privacy and confidentiality framework. Ms. Greenberg added the importance of transparency and education. Dr. Carr asked subcommittee leaders to think about next steps for their subcommittees in this context, prompting a few additional comments from members. Everyone affirmed that this is the beginning of a dialogue, and Dr. Carr reiterated the Committee’s interest in thisproject.

Subcommittee Reports, Strategic Plans and Next Steps

Subcommittee on Standards

Dr. Suarez enumerated the seven core items the Subcommittee plans to finish between now and December. It is developing a work plan.

Subcommittee on Population Health

Dr. Green said the Subcommittee would work with the Subcommittee on Privacy, Confidentiality and Security to consolidate the findings from the two workshops on community health information into a “foundational document.” He noted the possibility of another workshop to further formulate the Committee’s thinking about the community as a learning system for health, and to identify the unique NCVHS contribution in this space.

Subcommittee on Privacy, Confidentiality and Security

Dr. Francis said the Subcommittee would continue to work on privacy challenges and strategies in community data use, as well as undertaking other projects such as privacy challenges related to APCDs.

Subcommittee on Quality

Dr. Middleton noted the need to focus on the relationship between health care expenditures and quality in the U.S. Emerging topics for the Subcommittee include consumer-source data, the quality of quality of care data, andknowledge management.

Dr. Carr encouraged everyone to consider, as well, the tie-ins to the learning health system. She then adjourned the meeting.

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

/s/                                                                             June 16, 2011

____________________________________________________

Chair                                                                           Date