Department of Health and Human Services

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

September 15-16, 2010

Embassy Suites Crystal City Hotel
Arlington, VA

Meeting Minutes

The National Committee on Vital and Health Statistics was convened on September 15, 2010 at the Embassy Suites Crystal City Hotel in Arlington, VA. The meeting was open to the public. Present:

Committee members

  • Justine M. Carr, M.D., Chair
  • Leslie Pickering Francis, J.D., Ph.D.
  • Larry A. Green, M.D.
  • Mark Hornbrook, Ph.D.
  • John P. Houston, J.D.
  • Garland Land, M.P.H.
  • Blackford Middleton, M.D. (by phone)
  • Sallie Milam, J.D.
  • J. Marc Overhage, M.D., Ph.D.
  • William J. Scanlon, Ph.D.
  • Donald M. Steinwachs, Ph.D.
  • Walter Suarez, M.D.
  • Paul Tang, M.D.
  • Judith Warren, Ph.D., R.N.

Lead Staff and Liaisons

  • Marjorie Greenberg, NCHS, Exec. Secretary
  • James Scanlon, ASPE, Exec. Staff Director
  • Jorge Ferrer, M.D., VA liaison (by phone)
  • J. Michael Fitzmaurice, AHRQ liaison
  • Charles Friedman, Ph.D., ONC liaison
  • Karen Trudel, CMS liaison

Others

  • Debbie Jackson, NCHS
  • Marietta Squire, NCHS
  • Joy Pritts, J.D., ONC
  • Bill Alfano, BCBSA
  • Henry Heffernan, NIH
  • Keera Holly, PWC
  • Tammy Banks, AMA
  • Allison Viola, AHIMA
  • Michael DeCarlo, BCBSA
  • Thomas Bizzaro, First DataBank
  • Susanne Powell, Emdeon
  • Erin Richter, CAQH
  • Robin Thomashauer, CAQH
  • Frank Kyle, Jr., ADA
  • Jack Joseph, PriceWaterhouseCoopers
  • Stuart Hanson, Fifth Third Bank
  • Marshall Votta, NaviNet
  • John Wagner, The Clearing House
  • Jennifer Searfoss, United Healthcare
  • Jennifer Weisman, DHHS
  • Dan Rode, AHIMA
  • Hayley Anne Severance, Booz Allen Hamilton
  • Kathryn Schulke, Booz Allen Hamilton
  • Jeanette Thornton Barrett, AHIP
  • Matthew Van Sant, PriceWaterhouseCoopers

Note:  The transcripts of this meeting 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

(New NCVHS Chair: Justine Carr, M.D.)

ACTIONS

  1. Members unanimously passed a motion approving the recommendations and letter on operating rules for eligibility and claims status.
  2. By a unanimous vote, the Committee approved the recommendations related to a health plan identifier, as revised, and authorized the Subcommittee to work further on the letter, primarily to improve the presentation. The final version will be approved by the Executive Subcommittee and posted on the NCVHS website.
  3. By a vote of 9 to 3, the Committee passed a motion on a draft letter on sensitive information in medical records, with the following components:

A) Content

  1. The current content, modified with the following:
    1. Simplify the recommendations and move them forward in the letter.
    2. The Committee will recommend research and pilot testing of mechanisms to identify, manage, and protect sensitive information being exchanged in an electronic environment.
    3. The letter will also recommend an environmental assessment and solicitation of patient input.
    4. The letter will mention the areas of information that might be considered sensitive, consistent with current federal and state law, and suggest pilot testing in one or more of these areas.
    5. The letter will explain that the Committee’s thinking has evolved in recent years and recognizes that in addition to categories, there are other dimensions of protecting sensitive data, and that this is one of the reasons it is recommending research.

B) Process

  1. The Executive Subcommittee will have final say on approving, revising, or not approving the next draft of the letter. If the letter is not approved, it will be referred back to the full Committee.
  2. All NCVHS members will receive the new draft and be invited to express their views to the Executive Subcommittee prior to its decision.

Update from the Office of the National Coordinator – Chuck Friedman, Ph.D.

Dr. Friedman reported on the announcement of the 2011 meaningful use rule; developments in ONC programs; the projects of the SHARP grantees; and the work toward a rapid-learning health system (RLHS, or “Element 3”).

Update from the Chief Privacy Officer, ONC – Joy Pritts, J.D.

Ms. Pritts reviewed the duties of this office, created in HITECH/ARRA, and focused her update on its external activities. After describing the office’s current activities, particularly in relation to the HIT Privacy and Security Tiger Team and the Governance Workgroup, she said its next steps include continuing the FACA activity, standards and certification work, and increased outreach to other federal agencies and States in the context of health care reform.

In the discussion period, the group discussed ways to manage the interface between ONC and NCVHS.  Ms. Pritts and others noted the good working relationship already in place between the two in the privacy area. For the future, Dr. Friedman pointed to the emerging work on advancing the rapid learning system, which he noted is well aligned with the Committee’s traditional attention to public and population health issues. He expressed interest in engaging NCVHS around that work, and NCVHS members expressed corresponding interest.

Letter on Operating Rules on Eligibility and Claim Status – Dr. Warren

The Affordable Care Act (ACA) gives NCVHS responsibility for recommendations related to operating rules as well as a national health plan identifier. Of several stages of operating rules mentioned in the law, the ones with the earliest deadlines concern authoring organizations and rules for eligibility and claim status. The legislative timeframe is very short; the first two operating rules are to be effective by January 2013. To provide background for its work, NCVHS commissioned an environmental scan. The Subcommittee has worked closely with the designated standards maintenance organizations, and also has received considerable input from the industry.

On day 1 of the meeting, Dr. Warren presented the Standards Subcommittee’s draft letter on operating rules. She outlined the Subcommittee’s provisional recommendations, and the Committee discussed them at some length. On day 2, the letter was presented and approved.

Letter on National Health Plan Identifier – Dr. Warren

The ACA charges NCVHS with providing input to CMS on a process related to a national health plan identifier. The process is intended to result in a unique national plan ID supported by an enumeration database, standard instructions on which ID to use where, clear information for providers on how to submit transactions and obtain response transactions, reduction in manual processes, and improved ability to aggregate data for policy analysis and quality improvement.

On day 1, Dr. Warren explained that there is little agreement on the definition(s) of a health plan, product types, or intermediate entities. She reviewed the Subcommittee’s provisional recommendations, which are grouped around two sets of issues. The first concerns 1) who and what may obtain an ID and 2) who and what must obtain an ID. The second set is issues related to implementation and timing. NCVHS members discussed these issues and the proposed recommendations, with a focus on pinning down precisely what problem they were trying to solve and whose needs they are trying to meet.

On day 2, a revised letter was presented, discussed and further revised, and approved, subject to final work by the Subcommittee and approval by the Executive Subcommittee.

Privacy Letter on Sensitive Information in the Medical Record – Dr. Francis

After background comments and discussion, Dr. Francis presented the Subcommittee’s draft letter on sensitive information. The participants spent much of the remaining two-day meeting discussing this highly complex subject and what to say about it. On day 2, the Committee reviewed a revised version of the letter, and after extensive discussion, passed a motion outlined above (Actions). Dr. Francis and Dr. Green were asked to prepare the next draft.

DETAILED SUMMARY

Call to Order, Welcome, Review of Agenda

Dr. Justine Carr, the new NCVHS Chair, began the meeting by recognizing the enormous amount of work done over the summer by both the Standards and Privacy Subcommittees, to prepare the three letters that are under review at the present meeting.

Update from the Office of the National Coordinator Chuck Friedman, Ph.D.

Dr. Friedman reported on the announcement of the 2011 meaningful use rule, developments in ONC programs, the projects of the SHARP grantees, and the work toward a rapid-learning health system (RLHS, or “Element 3”).

Stage One of the “escalating” Meaningful Use criteria concerns data capture and sharing, and takes place in 2011; the following two stages are in 2013 and 2015. Dr. Friedman summarized meaningful use as formulated in the legislation, and ONC/CMS programs to achieve the objectives. These programs include regional extension centers, workforce training, Medicare and

Medicaid incentives and penalties, state grants for health information exchange, a standards and certification framework, and a privacy and security framework. Together, they are aimed at three intermediate objectives EHR adoption, meaningful use of EHRs, and exchange of health information all of which are aimed at achieving greater transparency and efficiency, better individual and population health outcomes, and improved ability to study and improve care delivery. Grants have been awarded to 17 Beacon Communities.

Dr. Friedman explained that ONC now uses the term health information exchange (HIE) to describe an activity rather than an entity; organizations that do HIE are referred to as health information service providers. In response to a question, he said he would get back to the Committee later with precise descriptions of  NIHN Direct, NHIN Connect, and NHIN Exchange.

In the Strategic Health Advanced Research Projects (SHARP) program, there are four grants. Dr. Friedman highlighted the work of the Harvard Group on advanced network and application platform, which is working on a “componentized” platform called Substitutable Medical Apps Reusable Technology (SMART). Its architecture will preserve or enhance the EHR’s privacy and security.

The Rapid-Learning Health System (also called “Element 3,” a term that Dr. Friedman said is being phased out) is a concept for a federated model to enable data to be safely and securely moved among institutions and aggregated for use in research, public health, and quality improvement. The approach anticipates using data for specific purposes rather than having them reside in a persistent centralized database. He gave some examples of possible functions, such as helping to track epidemics by using data from EHRs. To plan these activities, the Institute of Medicine is holding a series of three multi-stakeholder workshops, the last in early October. Three themes are emerging as the pillars for developing the system technology, governance, and patient engagement. A report of the findings will be published by year’s end, with a vision statement and description of a pathway to get there.

Update from the Chief Privacy Officer, ONC – Joy Pritts, J.D.

Ms. Pritts reviewed the duties of this office, which was created in HITECH/ARRA, and she then focused her update on its external activities. The position advises the National Coordinator on privacy, security, and data stewardship of electronic health information and coordinates with other Federal agencies, state and regional efforts, and foreign countries in that area. She stressed that the duties go beyond HIPAA.

Internally, the Office is working to ensure that privacy and security are embedded in all ONC programs. Externally, it is working closely with the HIT Privacy and Security Tiger Team (on which NCVHS member John Houston sits, with Dr. Francis as his alternate). They are making sure to build on NCVHS’ prior recommendations. Over the summer, they focused on technical issues surrounding consent and on data segmentation. Records of the proceedings and the resulting recommendations are on the website. In the Fall, the Tiger Team will meet twice a month (a less intense schedule than the summer’s) and focus on several “parking lot” issues and other priorities such as provider authentication.  The Tiger Team recommendations go to the Policy Committee, which accepts, rejects or modifies them and forwards them to ONC, which now has a process for promptly addressing the recommendations.

ONC coordinates with other government agencies including the Office for Civil Rights, which writes the HIPAA privacy regulations. There is also a Governance Workgroup (headed by Dr. John Lumpkin), charged with helping the National Coordinator establish a governance mechanism for the NHIN. It will work on this issue in late 2010 and early 2011, with tight deadlines.

The Office of the Chief Privacy Officer also participates with the Federal Health IT Interagency Task Force, and particularly the Cybersecurity Work Group, and consults with other agencies to identify best practices on security issues. It is continuing to work on personal health records in response to the HITECH mandate for HHS to report to Congress on privacy and security for uncovered entities; it is focusing on PHRs. Dr. Francis is working with them on this, and there will be a workshop in early December on how individuals interact electronically with their health information.

Next steps for the Office include continuing the FACA activity, standards and certification work, and increased outreach to other federal agencies and States in the context of health care reform.

In the discussion period, Dr. Green asked about plans for actively managing the interface between ONC and NCVHS. Ms. Pritts noted the good working relationship already in place on privacy and security issues, with someone always at the table who can represent the NCVHS perspective. Dr. Green affirmed that this relationship is exemplary for other dimensions of ONC’s work. Dr. Carr stressed the Committee’s desire to be integrated into the “growing landscape, as the tempo of work quickens, and its desire to know where it best “fits in.” Dr. Friedman pointed to the work on advancing the rapid learning health system, which he said is well aligned with Committee’s traditional attention to public and population health issues. He expressed great interest in engaging NCVHS around that work.

Dr. Hornbrook noted the Committee’s interest in access to electronic records for tracking the health of the society, and wondered about using a masking approach such as synthetic averaged individuals as well as registries to supplement surveys for this purpose.

Letter on Operating Rules on Eligibility and Claim Status:
Day 1 Presentation and Day 2 Action – Dr. Warren

The Affordable Care Act (ACA) gives NCVHS responsibility for recommendations related to operating rules as well as a national health plan identifier. Of several stages of operating rules mentioned in the law, the ones with the earliest deadlines concern authoring organizations and rules for eligibility and claim status. To provide background for the work of the Subcommittee on Standards on these assignments, NCVHS commissioned an environmental scan. Dr. Warren explained that this activity continues work the Committee has been doing on the transaction standards platform since 1998.

Operating rules are needed to reduce the complexity and variations, many of them regional, in the application of transaction standards to date. These variations have resulted in part from the flexibility initially built into HIPAA in these areas. The goal of the present effort around operating rules is to standardize the business requirements and reduce the need for companion guides (of which Dr. Suarez said there are thousands), to supply better information to patients and providers, and to give input to SDOs. The legislative timeframe is very short; the first two operating rules are to be effective by January 2013.

Dr. Warren outlined the alternatives and the Subcommittee’s provisional recommendations, and the Committee discussed them at some length. She said the Subcommittee has worked closely with the designated standards maintenance organizations, and also has received considerable input from the industry. (See day 1 transcript, page 41ff, for details of this presentation.)

The timeline set out in the law was one of several issues discussed by the Committee at this meeting. The Subcommittee recommends meeting the December 31 deadline. Another issue under discussion concerned whether an effort should be made to add the top ten best practices in the present phase (phases 1 and 2). The Subcommittee further recommends that CAQH CORE meets the requirements as the authoring entity for operating rules for non-retail pharmacy-related eligibility and claims status, and that NCPDP meets the requirements for retail pharmacy eligibility transactions.

The Executive Director of CAQH, Robin Thomashauer, who was present at this meeting, assured the Committee that the organization would give it their “best shot” to identify best practices through a consensus process by the deadline.

A motion was made that NCVHS meet the December 31 deadline with a recommendation of CAQH CORE and NCPDP, as outlined above. Further, the intention is by the deadline to continue the effort by CORE, in consultation with NCVHS, to integrate best practices that are not currently included. If this effort is successful, the Committee would have the opportunity to consider making a follow-up recommendation to the Secretary. No vote was taken on the motion. The Subcommittee on Standards will take the input from the foregoing discussion into its afternoon deliberations during the breakout session. The ultimate thinking of NCVHS about this matter will be expressed in its letter to the Secretary.

ACTION

In day 2 of the meeting, Dr. Warren reminded her colleagues of the ACA charges to NCVHS in this area. She then reviewed the recommendations in the proposed letter. After expressing few, if any, objections to the letter, members unanimously passed a motion approving the recommendations.

Letter on National Health Plan Identifier:
Day 1 Presentation and Day 2 Action – Dr. Warren

The ACA charges NCVHS with providing input to CMS on a process related to a national health plan identifier. The first NCVHS assignment in this area was part of the HIPAA legislation; however, the issue proved to be very complicated. The reason for the effort now is that proprietary identifiers are inconsistently applied to different entities within health care transactions. The lack of a standard identifier contributes to the challenges of efficiently and effectively using the standards, and reduces the ability to conduct studies on the impact of payers on health care spending and outcomes. The process is intended to result in a unique national plan ID supported by an enumeration database, standard instructions on which ID to use where, and clear information for providers on how to submit transactions and obtain response transactions; also it is intended to reduce manual processes and improve the ability to aggregate data for policy analysis and quality improvement.

Dr. Warren explained that the best practice, from an international standard, is that identifiers should have no meaning in them. There is little agreement on the definition(s) of a health plan, product types, or intermediate entities. She reviewed the Subcommittee’s provisional recommendations, which are grouped around two sets of issues. The first concerns 1) who and what may obtain an ID and 2) who and what must obtain an ID. The second set is issues related to implementation and timing.

NCVHS members discussed these issues and the proposed recommendations, with a focus on pinning down precisely what problem they were trying to solve and whose needs they are trying to meet. Dr. Carr urged a focus on achieving genuine simplification. The distinction between a plan and a product and whether products are what should be enumerated was one theme of the discussion. Ms. Trudel told the Committee that the hearings revealed that there is no consensus “out there” about what a health plan ID should enable. Another theme concerned whether there should be any qualitative criteria (a “threshold”) for being identified as a health plan and given a number. Dr. Green recommended incorporating the CMS definition of a health plan.

Mr. Scanlon suggested that NCVHS go beyond the explicit ACA charge so its input to the Department is logically related to other provisions of health reform and creates a conceptual link between the potential users of the plan identifier and aspects of health insurance reform such as those related to the functions of the portal and of health insurance exchanges. (A similar suggestion was made with regard to the Committee’s recommendations on sensitive information.)

The Subcommittee on Standards took the foregoing discussion into consideration as it worked on its revised letter to the Secretary.

ACTION

In day 2 of the meeting, Dr. Warren highlighted the major changes made to the health plan ID letter, starting with the recommendations. This was followed by extensive discussion, primarily on the nature of a health plan as distinct from a product, and on the purpose of the proposed NCVHS letter and recommendations (see day 2 transcript, pages 2-47, for details of the discussion).

Ultimately, members agreed on a set of recommendations that mostly articulate guiding principles. By a unanimous vote, the Committee approved the recommendations, as revised, and authorized the Subcommittee to work further on the letter, primarily to improve the presentation. The final version will be approved by the Executive Subcommittee and posted on the NCVHS website.

Privacy Letter on Sensitive Information in the Medical Record (Days 1 and 2) – Dr. Francis

Background comments

Dr. Francis, Co-Chair of the Subcommittee on Privacy, Confidentiality and Security, reminded Committee members that NCVHS recommendations on privacy in 2006, 2008, and 2009 had called attention to sensitive information issues and stated the Committee’s intention to define categories of sensitive information. The Subcommittee recently held a hearing on the subject, on the basis of which it developed the findings and recommendations in its draft letter. It also has conferred with the ONC Policy Committee about how to complement each other’s work. This project is part of the broader, ongoing effort to build trust in the health information systems and practices, to realize their potential to improve population and individual health.

Mr. Houston explained that the Subcommittee’s intent was to provide principles that address “about 95 percent of what people are concerned with,” in a form that can be applied as users see fit. He noted the Subcommittee’s interest in giving organizations guidance, based on the early experience of others in the field. It was stressed that the proposed findings and recommendations pertain not only, and not primarily, to treatment; Dr. Suarez stated that “the vast majority of issues” are disclosures for purposes other than treatment.

The group agreed that the ultimate question for NCVHS is what it can say that will be useful to public policy, and particularly to those with specific responsibilities to address this issue. Dr. Carr noted the Committee’s historic role of “teeing up” concepts, issues, and challenges so that technical specialists can work through them. Given the complexity of the issues at hand, the group agreed that sharing the Committee’s thinking and learning in this area could be beneficial.

Overview of the discussion

Dr. Francis presented the Subcommittee’s draft letter, and the participants spent much of the remaining two-day meeting discussing this highly complex subject and what to say about it. The details of the discussion can be found in the transcript posted on the NCVHS website (pages 80-144 on day 1 and 61-66 and 86-146 on day 2). Major points and themes of the discussion are outlined in the next section. Dr. Chuck Friedman, ONC liaison to NCVHS, was an active participant in the discussion because the Committee regards ONC as a prime audience and customer for its work output. He talked with the Committee about how to frame and focus its recommendations so they are most useful to the Department.

The discussion highlighted the unresolved complexities of these topics and led the Committee to shift from recommending a substantive approach to sensitive information categories to recommending research and testing. Although much of the discussion focused on the two categories already required by law, genetic information and substance abuse, ultimately members agreed to leave open which areas of information should be the research focus. Some urged that the NCVHS letter also leave open the possibility of finding methods other than categories for protecting sensitive data, because of continuing questions (for some) about whether categorization is feasible and constructive.

In the evening between the two days of meetings, Dr. Francis revised the letter based on the day-1 discussion, and she presented the revised version on day 2. ( Dr. Carr commended her for “unwavering fortitude in getting this right.”) The participants continued to refine the content of the letter and to discuss how to present it most effectively. Finally, a motion was made with the following components:

A) Content

  1. The current content, modified with the following:
    1. Simplify the recommendations and move them forward in the letter.
    2. The Committee will recommend research and pilot testing of mechanisms to identify, manage, and protect sensitive information being exchanged in an electronic environment.
    3. The letter will also recommend an environmental assessment and solicitation of patient input.
    4. The letter will mention the areas of information that might be considered sensitive, consistent with current federal and state law, and suggest pilot testing in one or more of these areas.
    5. The letter will explain that the Committee’s thinking has evolved in recent years and recognizes that in addition to categories there are other dimensions of protecting sensitive data, and that this is one of the reasons it is recommending research.

B) Process

  1. The Executive Subcommittee will have final say on approving, revising, or not approving the next draft of the letter. If the letter is not approved, it will be referred back to the full Committee.
  2. All NCVHS members will receive the new draft and be invited to express their views to the Executive Subcommittee prior to its decision.

The motion passed, by a vote of 9 to 3. Dr. Green and Dr. Francis were asked to revise the letter, based on the foregoing discussion.

Major themes and issues discussed:

  • Context: Several members did not support the Subcommittee’s initial effort (in Dr. Francis’ words) to “strip” the draft letter of “references to context.” The Committee returned many times to the feasibility and pros and cons of trying to characterize information, including its sensitivity, without reference to context. Dr. Friedman spoke to the importance of setting up the issues in a way that reflects current thinking. He noted the “emerging view that any element of data can take on attributes of its local context, expressed technically in its local metadata,” and urged that the NCVHS letter reflect this thinking in the way it frames the issues, to avoid suggesting that data have “permanent, persistent properties.”
  • Patient-centeredness: Some members cautioned against the notion that one solution or approach would work for all types of patients and situations.
  • Trade-offs: Members urged that the letter acknowledge the costs of enabling special protections for sensitive information, including costs related to burden, money, and impact on public health uses.
  • Content: There was considerable discussion of what categories of information (if any) should be addressed, and at what level of granularity. Possibilities included genetic information, substance abuse, mental illness, and sexually transmitted diseases. Some types of information are already protected by law; for example, GINA covers genetic tests and family history of disease, and employers are not allowed to request this information. Some NCVHS members favored focusing on information already covered by law, which would narrow the immediate focus to genetic information (GINA) and substance abuse (SAMHSA).

Following the discussion, Dr. Carr adjourned the meeting.