Department of Health and Human Services
NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS
September 13-14, 2006
Hubert H. Humphrey Building
Washington, D.C.
Meeting Minutes
The National Committee on Vital and Health Statistics was convened on September 13-14, 2006 at the Hubert H. Humphrey Building in Washington, D.C. The meeting concluded with a joint meeting with the Board of Scientific Counselors of the National Center for Health Statistics. The meeting was open to the public. Present:
NCVHS members
Simon P. Cohn, M.D., M.P.H., Chair
Jeffrey Blair, M.B.A.
Justine M.Carr, M.D.
John P. Houston, J.D.
Robert W. Hungate
A. Russell Localio, Esq., M.A., M.P.H., M.S.
Harry Reynolds
Mark A. Rothstein, J.D.
William J. Scanlon, Ph.D.
Donald M. Steinwachs, Ph.D.
C. Eugene Steuerle, Ph.D.
Paul Tang, M.D.
Kevin C. Vigilante, M.D., M.P.H.
Judith Warren, Ph.D, R.N.
Absent:
Stanley M. Huff, M.D.
Carol J. McCall, F.S.A., M.A.A.A.
Staff and liaisons
Marjorie Greenberg, NCHS/CDC, Executive Secretary
James Scanlon, ASPE, Executive Staff Director
Karen Trudel, CMS liaison
Steve Steindel, Ph.D., CDC liaison
Irma Elo, Ph.D., NCHS Board of Scientific Counselors liaison
Virginia Cain, NIH liaison (for joint meeting with BSC)
Ed Sondik, Ph.D., NCHS liaison (for joint meeting with BSC)
NCHS Board of Scientific Counselors members and staff
June O’Neill, Ph.D., Chair
Irma Elo, Ph.D.
Donald Hernandez, Ph.D.
William Kalsbeek, Ph.D.
Thomas Koepsell, M.D.
James Lepkowski, Ph.D.
Janet Norwood, Ph.D.
Neil Powe, M.D.
Louise Ryan, Ph.D.
Steven Schwartz, Ph.D.
Matthew Snipp, Ph.D.
Virginia Cain, Ph.D., NCHS, Executive Secretary
Rob Weinzimer, NCHS, staff
Absent:
Nicholas Eberstadt, Ph.D.
Raymond Greenberg, Ph.D.
Michael Grossman, Ph.D.
Ruth Stein, M.D.
Others
Debbie Jackson, NCHS
Dan Rode, AHIMA
Allison Viola, AHIMA
Michael DeCarlo, BlueCross BlueShield
Douglas Boenning, ASPE
Nancy Ferris, Government HealthIT
Carol Bickford, American Nurses Assn.
Jack Swenson, Keane Worldzen
Jessica Townsend, HRSA
Frank Kyle, Amer. Dental Assn.
David Slaughter, TPG
Sheilah Dwyer, Amer. Optometric Assn.
Elizabeth Hallen, Mitre
Denise Buenning, CMS
Susan Baird Kanaan
EXECUTIVE SUMMARY
ACTION:
The Committee approved a draft letter commenting on and concurring with the Consolidated Health Informatics Initiative recommendations on the allergy domain.
UPDATE FROM THE DEPARTMENT
· Data Council—Jim Scanlon, ASPE
· HIPAA Implementation and e-Prescribing—Karen Trudel, CMS
· Privacy Rule Compliance Update—Sue McAndrew, OCR
Mr. Scanlon discussed the President’s August 22 Executive Order, whose purpose is to promote the use of health information technology (HIT), transparency regarding quality and prices, and better incentives. He called attention to two HIT bills worth watching, H.R. 4157 and S.1418.
Ms. Trudel reported that as of October 1, all electronic remittance advices sent to providers will be HIPAA compliant. On the National Provider ID (NPI), about 1.2 million providers have been enumerated to date. CMS and WEDI will work together to develop outreach messages for providers on the use of NPIs. There was a two-day joint HHS/DEA hearing on e-prescribing for controlled substances. DEA and HHS are reviewing the testimony and will work together to find a workable plan. The e-prescribing pilots end December 31, and the report to Congress is due in April 2007.
Ms. McAndrew reported that OCR is participating on AHIC’s Consumer Empowerment and Privacy and Confidentiality Workgroups. More than 22,000 complaints had been received by the end of August, with a closure rate of 75 percent. OCR is looking into ways to mine the database for more information about compliance. It is giving priority in its investigations to cases involving complaints about individual rights violations. It is also looking into identity theft and methamphetamine logs, working with disaster response teams to promote understanding of the privacy rule, and working with the research community to address research issues related to the privacy rule.
NCVHS members hailed the breadth of OCR activities, and particularly its attention to researchers’ concerns.
UPDATE ON OFFICE OF THE NATIONAL HIT COORDINATOR—Dr. John Loonsk
Dr. Loonsk described the recent activity of AHIC’s working groups. AHIC has identified priority areas for next steps, such as developing an emergency responder EHR use case and further work in the quality area. It will hold the second Nationwide Health Information Network Forum in October.
In the discussion period, members had questions about the breadth or specificity of the AHIC privacy workgroup’s agenda and plans for its quality workgroup’s agenda. Dr. Fitzmaurice asked about efforts to link together the progress ONC has facilitated in the areas of interoperability specifications, NHIN functions, and proposed architectures; Dr. Loonsk agreed that it is a challenge to coordinate the products. Dr. Fitzmaurice also noted people’s hope that ONC will develop a model that shows how everything is meant to fit together and be used.
AD HOC WORK GROUP LETTER: NATIONWIDE HEALTH INFORMATION NETWORK
The draft letter on the NHIN was presented for discussion. The revised document will be put out for public comment in the coming weeks because of the importance of having the involvement of the main stakeholders. It will be finalized in late October. Dr. Cohn and Dr. Loonsk thanked everyone involved for their hard work on this project. Mr. Reynolds explained that the Workgroup worked hard to create a comprehensible structure for this complex and diverse subject and to make the contents understandable. The appendices of the letter are important as they contain the greater technical detail, and so are the precise definitions given for terms used.
Margret Amatayakul then read the observations and recommendations in the report, and the group discussed each set. Members identified some sections needing clarification and in a few cases suggested alternative language.
UPDATE ON HEALTH INFORMATION TECHNOLOGY STANDARDS PANEL (HITSP)
—John Halamka, M.D., Chair, HITSP
HITSP encompasses 206 member organizations and is administered by a Board of Directors, on which Dr. Halamka serves as a non-voting Chair. It reports to AHIC and the National Coordinator. HITSP’s deliverables—interoperability specifications and a business plan for self-sustaining processes—will be released on September 29 following voting on the 20th after a formal comment period. The project has required intensive work by the project management team and some 12,000 volunteer hours over a period of six months. There has been diverse stakeholder representation and a strong commitment to inclusiveness. Harmonization consisted of reducing 700 standards to about 20 as of this meeting. Following the standards selection, HITSP constructed interoperability specifications. The HITSP process was very open, with decision-making by consensus. Testing was rigorous and followed a rapid schedule.
Dr. Halamka pointed out a number of incomplete aspects, estimating that HITSP will have completed about one third of the necessary work by September 29. The consumer empowerment recommendations are in two stages because the Continuity of Care Document (CCD) is not finished yet. Also, there are not yet any privacy and security policies or architecture, and substantial work is needed on the business sustainability of HITSP. An important thing to figure out is a consistent process for every organization building standards, code sets and implementation guides to follow, so they all work together. Further work is also needed on terminology. In the discussion period, Dr. Halamka stressed that “standards are not a product but a process,” and he and the Committee discussed the need for further work on aspects of the HITSP recommendations.
SUBCOMMITTEE ON STANDARDS AND SECURITY LETTER
The Committee reviewed a draft letter concurring with and commenting on the Consolidated Health Informatics Initiative recommendations on the allergy domain. It passed a motion approving the letter.
AHRQ QUALITY INDICATOR PROJECT UPDATE— Mary Beth Farquhar
The AHRQ quality indicators (QIs) are performance measures, based on administrative data, in the areas of inpatient, pediatric, prevention and patient safety. There are 86 indicators, each of which can be stratified by variables including race, age, sex, provider and geographic region. The QIs, documentation software and technical support are available free of charge to all users, and AHRQ maintains the QIs.
AHRQ is submitting the QIs to the National Quality Forum consensus development process for approval. It is in consultation with the NCVHS Quality Workgroup on this project. AHRQ has a range of activities related to this project, including creating composite measures, convening a risk adjustment workgroup, conducting validation studies and developing new QIs. It has a contract with RAND to look broadly at the QI area. They have completed their draft report and will deliver a final one on November 1. AHRQ still needs advice on strategic directions for the future in this area.
In the discussion period, members proposed that AHRQ try deriving quality measures from primary clinical data, and suggested a possible Committee role in making clinical data more useful for quality measurement. They also discussed the potential for manipulating data and the influence of monetary incentives on provider behavior.
JUNE RETREAT REVIEW; PROPOSED PROCESS IMPROVEMENTS
The group reviewed the broad themes of the June retreat, alternative approaches to Committee structure, and several specific process improvements. They agreed to continue the existing structure, including the option of ad hoc workgroups, for the coming year.
REPORTS FROM SUBCOMMITTEES AND WORKGROUPS
(See the brief summaries on pages 12-13)
—JOINT MEETING WITH NCHS BOARD OF SCIENTIFIC COUNSELORS—
The meeting concluded with a joint session with the Board of Scientific Counselors of the National Center for Health Statistics. The session began with introductory comments from the two chairs, Dr. Cohn and Dr. O’Neill; the groups’ liaisons to each other, Dr. Scanlon and Dr. Elo; and Dr. Sondik. The comments stressed the complementary missions of the two bodies and the desire to find synergies to maximize their impact. The group then heard presentations on pressing issues in vital statistics and discussed how they might collaborate to promote solutions.
IMPLICATIONS OF CONFIDENTIALITY REQUIREMENTS IN NATALITY AND MORTALITY VITAL STATISTICS
· State Perspective—Steven Schwartz, Ph.D., NAPHSIS
· NCHS Perspective—Charlie Rothwell, NCHS
Dr. Schwartz described the Vital Registration System, operated by states in cooperation with the federal government. State laws and practices are diverse, and there is no national policy in this area. The System is threatened by identity theft, national security measures and changing technology. He highlighted the challenge of balancing public health and research benefits with protections against the threats listed above and need to address the risks created by technology and to strengthen enforcement. The goal is to maximize the use of vital statistics data for public health purposes while protecting confidentiality and complying with state laws and regulations.
Mr. Rothwell discussed the compromise NCHS has reached with states regarding the issues described above, particularly to comply with state law. NCHS releases vital statistics at three stages, with a final release of clean and complete data in public use files that are available to researchers and analysts. The public use file is now a national file with no geographic specificity. He described this compromise as less than ideal but the best that could be worked out.
In the discussion period, Dr. Schwartz commented that there is an opportunity for leadership to craft a model state law on data release; Mr. Rothwell agreed that there is an opportunity to educate states on the best way to compile and release data.
ELECTRONIC DEATH REGISTRATION: RE-ENGINEERING STATE AND FEDERAL SYSTEMS—Mr. Rothwell
Dr. Rothwell described current problems with death reporting, stemming largely from the dependence on distinct sources for demographic and medical information. As part of the e-Gov initiative, NCHS has recently received funding to start implementing Electronic Death Registrations (EDRs) to supplement improvements spearheaded by the Social Security Administration. Once EDRs are in place, the federal government will have a complete record of deaths within a few days of the event and at the same time that the state health department has the information. There are unresolved questions about how to release the information, and other matters, and Mr. Rothwell said the two advisory bodies could be very helpful in figuring out how to handle them.
NEXT STEPS
In the final discussion by the two groups, the following ideas were put forward:
- Referring these issues to the NCVHS Subcommittee on Populations, in the context of its review of progress toward the Vision for 21st century health statistics and its work on data linkages;
- Bringing the issues forward at a higher level, possibly through a joint letter to the Secretary;
- Taking a look at the data user agreements;
- Pursuing the role of electronic health records and the notion of overall EHR activity that includes vital statistics as an integral aspect;
- Getting this concept on AHIC’s radar screen;
- Supporting the Center’s role in bringing the states on board;
- Encouraging further research and work on best practices and model statistics laws;
- Paying attention to cost, funding and resource use issues; and
- Reconvening the organizing group for this meeting to talk further about next steps.
DETAILED SUMMARY
—DAY ONE—
CALL TO ORDER, WELCOME, INTRODUCTIONS, REVIEW OF AGENDA
Dr. Cohn called the meeting to order. Following introductions around the room, he commented on the Committee’s hard-working summer, the growing attention to the recent NCVHS report on privacy and the NHIN, and the work in progress by other bodies, notably the NHIN Workgroup. All of this takes place against a backdrop of intensified Congressional and Departmental activity. He noted that this meeting would conclude with a joint meeting with the Board of Scientific Counselors of the National Center for Health Statistics.
UPDATE FROM THE DEPARTMENT
Data Council—Jim Scanlon, ASPE
Mr. Scanlon first discussed the President’s August 22 Executive Order, “Promoting Quality and Efficient Health Care in Federal Government-Administered or -Sponsored Health Care Programs.” Its purpose is to promote the use of health information technology (HIT), transparency regarding quality and prices, and better incentives. It directs federal agencies and their contractors to adopt HIT that meets recognized interoperability standards (recognized by SDOs and the Secretary) when they acquire or upgrade their systems. The focus is on convergence, standards, and certified systems. There are also provisions related to the transparency of quality measurements and pricing, also based on standards. Compliance is ordered by January 1, 2007. Details such as to whom the Order applies are still being worked out. The primary focus is on the “first ring” of federal health programs—those directly administered such as VA, DoD and IHS. In response to a question, Mr. Scanlon confirmed that this Order is the next step in the government’s Consolidated Health Informatics (CHI) process.
On the Hill, two notable HIT bills, H.R. 4157 and S.1418, are worth watching. Particularly in the House bill, there are provisions that give NCVHS a central role in the upgrading, addition and modification process for HIPAA standards. Some standards recommended by the Committee would be promulgated as final rules. The bill directs the Department to adopt several standards and promulgate rules related to specific transactions, linking a public federal role to the open SDO process. There are also grant programs in both bills, and privacy provisions. It remains to be seen how they would be coordinated with the final rules that HHS has already issued.
To questions from members, Mr. Scanlon said the Committee would be able to recommend implementation dates and that additional resources for NCVHS for these purposes are possible.
HIPAA Implementation and e-Prescribing—Karen Trudel, CMS
As of October 1, all electronic remittance advices sent to providers will be HIPAA compliant. CMS is piloting a program to do Medicare eligibility queries and responses over the Internet. On the National Provider ID (NPI), about 1.2 million providers have been enumerated to date. The data dissemination notice is under review, and the process will begin as soon as possible. CMS met with a WEDI group to discuss concerns about claims processing and what can be done to expedite enumeration. They will be working together to develop outreach messages for providers regarding the use of NPIs. Any planning for enforcement will depend on whether there are problems with compliance.
There was a two-day joint HHS/DEA hearing on e-prescribing for controlled substances. The testimony highlighted the features of existing e-prescribing products and aired different solutions that might be used for both controlled and non-controlled substances. One message was that the fill status notification would be a tool. DEA is reviewing the testimony, and HHS is working with them to find a workable plan. This will be reported at an October hearing by the Subcommittee on Standards and Security.
The e-prescribing pilot ends December 31, testing standards to see if they transmit the appropriate data in a manner useful to the receiver. The second priority is return on investment. The report to Congress is due in April 2007.
Mr. Localio called attention to the concern that the FDA does not have a database containing all the medications, and he asked about plans to fill that gap. Ms. Trudel said there is experimentation about linking up with RX-Norm and the NDC. Mr. Blair added that the Subcommittee on Standards and Security plans a series of testimonies on that question in October or December. Dr. Fitzmaurice said AHRQ is funding various public databases of drug product listings, involving FDA and the NLM.
Privacy Rule Compliance Update—Sue McAndrew, OCR
OCR is participating on AHIC’s Consumer Empowerment Workgroup, which is focusing on personal health records and looking into existing models. It is also part of AHIC’s Privacy and Confidentiality Workgroup, launched in August and planning a hearing in late September.
On the compliance front, OCR had received more than 22,000 complaints as of the end of August, and maintains a closure rate of 75 percent. It is looking into ways to mine the database for more information about compliance. OCR is giving priority in its investigations to cases involving complaints about individual rights violations, in an effort to put these on a faster track for resolution.
OCR is also looking into identity theft as part of a White House committee on the subject. The Department as a whole is taking a stronger and more organized approach to the issue. OCR has been working on issues related to the regulations on methamphetamine logs and working with disaster response teams to promote understanding of the privacy rule. It has posted a new tool for disaster response planners. Finally, OCR is working with the research community to address research issues related to the privacy rule. The IOM held a public hearing on this in the summer. The problem areas include recruitment and issues about identifiable information.
On the issue of identity theft, Mr. Houston “implored” the government not to let the fact that financial institutions have compromised the reliability of SSNs through unwise credit practices tie the hands of health care institutions that rely on social security numbers. Hospitals depend on SSNs for historical information, even if they are developing other unique numbers. On disaster response, he urged that the OCR guidance be comprehensive enough to enable hospitals to properly inform local authorities and others to help locate people in a disaster.
To another question, Ms. McAndrew said OCR does not currently have anything addressing the privacy solutions in an NHIN environment, for example on RHIOs and state and local health information exchanges.
Asked what is next with regard to research community issues, she said IOM may mount its own inquiry within a year. The Department is currently focusing on guidance, and it will be working out issues more concretely in the next 2-3 months. Any possible rulemaking or rule modifications would take at least a couple of years, especially if OCR waits for an IOM process.
Mr. Blair said that if OCR begins to work on privacy issues related to matching patients to their records, which he hopes it will, it would be helpful if there were federal guidance for protecting privacy and security in data subscription agreements. He noted that the EHI initiative has a common framework with guidance, which might shortcut OCR efforts. In addition, all the RHIOs and HIE networks in the U.S. are developing data subscription agreements and they would like assurance that they meet federal requirements.
Dr. Cohn was one of several to hail the breadth of OCR activities, and particularly its attention to researchers’ concerns. He also noted the progress on e-prescribing, which is likely to be the leading edge of the NHIN.
FULL COMMITTEE RETREAT
The group briefly discussed the full Committee retreat held in June. (It addressed specific process improvements on day two.) Dr. Cohn called attention to the bios from members and lead staff, compiled in response to members’ desire to get to know each others’ interests better. On another recommended process improvement, speakers will be held to time limits to leave more time for discussion.
Members affirmed that the retreat was very valuable in stimulating interaction and giving Committee members a better sense of the work of subcommittees and workgroups of which they are not members. Future full Committee retreats will help orient new members.
UPDATE ON OFFICE OF THE NATIONAL HIT COORDINATOR—Dr. John Loonsk
After discussing the August Executive Order, Dr. Loonsk described the recent activity of AHIC’s working groups, each of which has addressed its specific charge and is now thinking about its broader charge. For example, the EHR Workgroup is now starting to envision the next steps of EHR adoption and the implications for the national agenda. AHIC has identified priority areas for next steps, such as developing an emergency responder EHR use case and further work in the quality area. It has put the Confidentiality, Privacy and Security working group in place, and it will be moving toward demonstrations and implementation. The group is one of several that are working with documents and recommendations put forward by NCVHS in the past.
ONC will hold the second Nationwide Health Information Network Forum in October, focusing on the practical implementation and policy issues related to security for the NHIN as well as the desired attributes of NHIN service providers. The forum will also discuss architecture variations. The general thrust is to move the process forward, building on the first forum.
Discussion
Mr. Rothstein asked if the privacy workgroup would address the broader privacy issues that go beyond its current focus of the privacy issues in the AHIC uses cases to include the broader range of issues addressed by the NCVHS Subcommittee on Privacy and Confidentiality. Dr. Loonsk said the broad issues are on people’s minds, but the workgroup’s approach is to focus on the specific implementation issues related to the breakthroughs, as a way of contextualizing the high-level issues. Dr. Cohn noted that the Secretary has asked NCVHS to take the longer view, so these are compatible.
Asked about the new Quality Workgroup’s agenda, Dr. Loonsk said the immediate charge is to think about a subset of quality reporting metrics, aiming for practical implementation. The group has not met yet.
Asked about the implementation of interoperability specifications for the use cases assigned to HITSP, Dr. Loonsk said these specs are intended to represent implementations of standards that have been worked through SDOs, not new standards. They are meant to articulate how data exchange should happen. (See Dr. Halamka’s presentation later in this meeting for further details on HITSP.)
Dr. Fitzmaurice asked if there are efforts to link together the progress that ONC has facilitated in the areas of interoperability specifications, NHIN functions, and proposed architectures. Dr. Loonsk agreed that it is a challenge to coordinate the products. CCHIT and HITSP will have a joint working group to ensure that their products work together. The use cases are helpful in that regard, he added. Also, it is hoped that NCVHS will be represented at the NHIN forum, where the standardization needs of the architectures will be discussed. ONC is looking at different mechanisms to be sure that the pieces work together. Dr. Fitzmaurice noted people’s hope that ONC will develop a data or information model that shows how everything is meant to fit together and be used. Dr. Loonsk said a lot of thought has been given to that issue.
AD HOC WORK GROUP LETTER: NATIONWIDE HEALTH INFORMATION NETWORK
Dr. Cohn explained that the intent of the forthcoming discussion is to develop a comfort level with the letter developed by the ad hoc NHIN Workgroup. The document will be put out for public comment in the coming weeks because of the importance of having the involvement of the main stakeholders; it will be finalized in late October. He noted that Dr. Loonsk’s presentation helped frame the broad issues involved. He thanked his Co-Vice-Chairs, Mr. Reynolds and Mr. Blair, the Workgroup members, lead staff person Dr. Deering, Dr. Steindel and others who provided support, and writer Margret Amatayakul. Dr. Loonsk added his thanks to the Committee, and particularly the individuals named above, for taking on and expediting this challenging project.
Mr. Reynolds described the discussion process that he would be leading. He noted that the Workgroup had worked hard to create a structure for this complex and diverse subject and to make the contents understandable to non-experts without being too pedestrian for the experts. The appendices of the letter are important as they contain the greater technical detail. Mr. Blair described the structure of the document and urged NCVHS members to give feedback on whatever is not understandable so it will ultimately be something the public can understand.
Mr. Reynolds stressed that the letter tries to make clear that what is called the NHIN is “a system of systems” in the public and private sectors, not a central entity or bricks-and-mortar part of government. It has to encompass wide differences in design and service among existing components and disparate views about how to “group up.” Further, it may be necessary over time to reduce the number of variations for greater efficiency and effectiveness: “We are building this thing as it goes.” Finally, because key terms are used and understood in different ways, it is important to pay attention to the definitions used in the document.
Ms. Amatayakul then read the observations and recommendations, and the group discussed each set.
This discussion took place in three stages in the course of this meeting. The group addressed recommendations 0-11 before breaking for a presentation by Dr. Halamka, and afterwards reviewed recommendations (12-15). Members identified some sections needing clarification and in a few cases suggested alternative language. For the details of the discussion, the reader is referred to the meeting transcript, posted on the NCVHS Website. (See pages 71-164 and 213-222 of day one.)
One idea arose that went beyond the document. It was suggested that the Committee make available or point readers to a summary of testimony it has received on matching patients to their records, to provide potentially useful background for the recommendation on person identification (#4).
Mr. Reynolds noted that the Workgroup was not asked to address policy issues, nor to recommend standards. In each case, however, it identified the ones that arose and recorded them in the letter, for possible future attention.
UPDATE ON HEALTH INFORMATION TECHNOLOGY STANDARDS PANEL (HITSP)
—John Halamka, M.D., Chair, HITSP
Dr. Halamka commented that the interoperability specifications now on the HITSP Website overlap nearly completely with the CHI standards on which NCVHS worked for several years. HITSP encompasses 206 member organizations and is administered by a Board of Directors, on which he serves as a non-voting Chair. It reports to AHIC and the National Coordinator. Importance is attached to the participation of patient advocates along with the other stakeholder groups. HITSP’s deliverables—interoperability specifications and a business plan for self-sustaining processes—will be released on September 29 following voting on the 20th. Reaching this point has required intensive work by the project management team and some 12,000 volunteer hours over six months. Dr. Halamka noted his surprise at the number of people willing to give large amounts of time to this effort. They served on three committees (panels) based on the use cases—biosurveillance, consumer empowerment and EHR interoperability. There has been diverse stakeholder representation and a strong commitment to inclusiveness.
The use cases were received on March 1 and translated into a set of actions, actors and events, each of which had individual standards placed against them. There were 700 candidate standards for the three use cases; even so, there are gaps that have been called to the attention of the SDOs. There are also complicated overlaps in standards and terminologies. Harmonization consisted of reducing 700 standards to “a more manageable number” — about 20 as of this meeting, with a goal of reducing the number further in the future. This required getting “beyond emotion” and involved “very high-level standard criteria,” notably cost and ease of implementation. Following the standards selection, HITSP constructed interoperability specifications. Dr. Halamka pointed out the challenges of having to do this “in the total absence of architecture,” making it necessary to maintain architectural flexibility. He explained that HITSP prescribed a messaging standard, not an architecture.
Dr. Halamka described the HITSP process, which was very open (with minutes for every meeting) and with decision-making by consensus. He has gone to extra lengths to encourage broad participation in voting. He described the informal comment period on the draft specifications as “a mistake” because they got 704 comments and were unable to formally respond to them. However, all the comments were read, they were very helpful, and they will be addressed during the formal comment period, September 13-20.
The consumer empowerment specification is split into “interim state” and “final state” elements because the latter depends on the Continuity of Care Document (CCD), which is not finished yet. The interim solution, he said, should motivate people to move quickly to the final CCD state. In general, he estimated that HITSP will have completed about one third of the necessary work by September 29. Another source of ambiguity in the short run is the absence of privacy and security policies, which the AHIC Workgroup on privacy will develop. Substantial work is also needed on the business sustainability of HITSP, which expects to work on new use cases coming from AHIC. An important thing to figure out is a consistent process for every organization building standards, code sets and implementation guides to follow, so they all work together.
Further work is also needed on terminology. Dr. Halamka showed a graphic of the HITSP Framework and commented on the complexities of terminology in relation to standards. HITSP built a set of terminologies called base standards, transactions and transaction packages. They come with a “crisp set of definitions.” He then discussed issues related to the interim-state consumer empowerment recommendations. For all use case recommendations, he said, the idea is to produce functional, content-specific packages that can be taken off the shelf and reused for any use case. The biosurveillance use case is the least controversial. It contains some gaps, and is a work in progress.
Finally, Dr. Halamka commented on testing, noting the rapid testing schedule and stressing that “this was not any kind of rubber stamp.” It was done by 50 volunteers through five teleconferences.
Discussion
Committee members had a number of questions, including one about how HITSP planned to handle changes in standards. Dr. Halamka commented that as a major payor, the government should have a role in sustaining HITSP, which will constantly update the interoperability specifications as new standards are issued. He stressed that “standards are not a product but a process.” He and the Committee discussed the need for further work on aspects of the HITSP recommendations and the possibility that some percentage may be sent back for more work. On the issue of proprietary standards Dr. Halamka said that so far, HITSP has “not found the need for” any of them. The companies with proprietary standards have understood the HITSP criteria.
SUBCOMMITTEE ON STANDARDS AND SECURITY LETTER
The Committee reviewed a draft letter commenting on and concurring with the Consolidated Health Informatics Initiative recommendations on the allergy domain. Dr. Steindel explained the document and the five component standards. Mr. Reynolds said Beth Halley of CHI had “brought a cast of thousands” representing multiple government agencies to the Subcommittee’s hearing on this matter, and they were all in concurrence.
Following a brief discussion, the Committee passed a motion approving the letter. Dr. Cohn congratulated CHI for accomplishing standards in this complex and difficult area. The next area that will be tackled (in October) is disability.
The group then returned to the NHIN letter, to review recommendations 12-15, following which members recessed into Subcommittee and Workgroup meetings.
—DAY TWO—
AHRQ QUALITY INDICATOR PROJECT UPDATE— Mary Beth Farquhar
Ms. Farquhar began by thanking the Committee for its help on this project. The AHRQ quality indicators (QIs) are performance measures based on administrative data. There are inpatient, pediatric, prevention and patient safety QIs. The latter are the most recent. The pediatric QIs include indicators from the other three areas. The indicator definitions are based on ICD-9-CM codes and procedure codes. The numerator is the number of flagged cases; the denominator is the population at risk. Together they make up the observed rate. The QIs, the documentation software and technical support are available free of charge to all users. AHRQ gets a lot of input from users on how to revise the indicators, which it does yearly. The fact that AHRQ maintains the indicators is another advantage. There are 86 indicators, each of which can be stratified by variables including race, age, sex, provider and geographic region.
AHRQ is submitting the QIs to the National Quality Forum consensus development process for approval. In preparation, it worked to make them as strong as possible for administrative data. The QIs are used for the National Healthcare Quality and Disparities Reports, and nine states use them for public hospital reporting. Their limitations stem from the limitations of administrative data. Also, they were developed for quality improvement but are being used for other things, and there are risk adjustment and timing limitations.
Ms. Farquhar described the range of activities for this project. There are currently unaligned efforts among hospitals reporting on certain measures and states using others, creating burdens on reportees. AHRQ has asked for volunteers for three workgroups creating composite measures for procedures, mortality for conditions, and overall patient safety. Two draft reports are now out for public comment. It has also convened a risk adjustment workgroup, and is doing literature reviews. It selected 32 indicators to submit for NQF submission along with a reporting template that is being tested on consumer groups, providers, focus groups and others. AHRQ also put out a call for partners for validation studies of the indicators, particularly those on patient safety, a topic in which there is a lot of interest.
On risk adjustment, the Agency investigated several models and methods. It has also worked on having the whole program evaluated. RAND has been working for more than a year on a contract to survey the market of QIs, performance measures and measurement tools; the major players; what is available and where the gaps are. They have completed their draft report and will deliver a final one on November 1. RAND gave an overview of the findings to the Quality Workgroup. Rand found that people liked the QIs and the scientific evidence behind them and the fact that AHRQ maintains them. However, they did not offer guidance on strategic direction regarding where AHRQ should go next. Ms. Farquhar said they could use help in this area.
AHRQ also is doing validation studies, for which it had many volunteers, and it is developing new QIs in the pediatric area, scheduled for release in Winter 2007. Future research proposals include additional validation studies, linking the QIs to clinical data elements, linking them to other data sets, and developing new QIs. In conclusion, Ms. Farquhar said she has had good discussions with the Quality Workgroup and will continue to get their input on next steps.
Discussion
Noting that current methods can produce inaccurate results or inadequately identify the population at risk, Dr. Tang asked if AHRQ had any plans to try deriving quality measures from primary clinical data, rather than validating old administratively derived measures.
Dr. Vigilante commented that the Committee might consider possible roles that are distinct from those of AHIC in regard to making clinical data more useful for quality measurement, given the limitations of EHRs for this purpose.
Dr. Steuerle commented on the possibilities of manipulating data and asked what mechanisms AHRQ was considering to control such behavior. Dr. Carr remarked that monetary incentives influence behaviors in particular directions, as well, even when no fraud is intended. Dr. Scanlon stressed the importance of these issues and noted the absence of any mechanisms for attacking the problem as well as its seemingly prohibitive scale.
JUNE RETREAT REVIEW; PROPOSED PROCESS IMPROVEMENTS
Dr. Cohn referred the group to a summary of proposed process improvements, drafted by Ms. Greenberg. The June retreat ideas were reviewed by the Executive Subcommittee in July and converted to specific process improvement proposals. Dr. Cohn noted that at a high level, the retreat reaffirmed the NCVHS vision and its commitment to the crosscutting priorities of patient engagement, population health improvement, and provider process improvement. Privacy and security are underlying priorities, along with quality. Because of limited resources and the many tasks assigned by government, the Committee must be careful to determine where it can make the greatest difference and add real value. He added that the retreat did not point to any need to change the NCVHS structure. Members agreed to use ad hoc workgroups as needed, to add flexibility.
Dr. Tang noted the value of cross-fertilization and suggested that NCVHS sub-groups give each other cross-assignments so they are sure to work in concert and not overlook each other’s domains. Dr. Steinwachs added that the Committee should develop mechanisms for identifying and handling the cross-cutting dimensions of projects. Dr. Vigilante commented that the Committee has an important role to play related to information-sharing for research, a topic AHIC is not directly addressing.
The discussion turned to the best structure for approaching the Committee’s work. Dr. Carr imagined a grid with the three priority areas on one axis and the Subcommittee and Workgroup areas on the other. She wondered how NCVHS projects fit in to this schema. Dr. Cohn said the idea is to use the three priorities to avoid confining tasks to a single subgroup, but rather to encourage looking across all the domains. Dr. Tang proposed using ad hoc project groups instead of the existing structure. Mr. Scanlon observed that the Committee’s work falls into the large categories of HIT/HIPAA and data applications, and both need to focus on all three priority areas and have dialogue between them.
Mr. Houston took issue with the proposition that the NCVHS structure is satisfactory, noting that security is not adequately addressed. He advocated shifting it to the Privacy Subcommittee, where it would have a better home. The discussion returned to this concern several times, with general agreement that the issue will be increasingly pivotal and that ideally, absent other constraints, security should be grouped with privacy. However, there was recognition of many constraints. Dr. Cohn pointed out that security is “60% of what the NHIN Workgroup is talking about,” so it has a vehicle for the time being.
Turning to the topic of project development, he noted the agreement at the retreat that new projects should be brought to the full Committee at the very beginning, for discussion of the best way to handle them. Joint projects should be encouraged when appropriate. Future agendas will allow more time for the reports of NCVHS subgroups, to encourage ongoing cross-fertilization.
Mr. Rothstein cautioned that the desire to do “100 new things” or create a new structure must be tempered by awareness of all the tasks thrust upon the Committee by Congress or the Department. He reminded the group of the Committee’s limited resources and encouraged decisions that take these constraints into consideration. Dr. Carr reminded the group to “look to our membership” and remember the expertise around the table. Dr. Steuerle added that some members are better at identifying gaps in information systems and data, while others are better at providing the architecture.
Mr. Reynolds affirmed that the current structure works well, especially with the flexibility afforded by ad hoc workgroups. He suggested that members volunteer for projects rather than waiting to be recruited. On the security issue, he pointed out that it is a base requirement for every NCVHS subcommittee and workgroup domain.
Dr. Cohn proposed that the Committee go forward with its “hybrid structure” for the next year, and the group agreed. He then reviewed the recommendations on adjudicating letters and reports and on dissemination. More effort will be made to present NCVHS documents in professional, attractive designs and formats. Dr. Steuerle suggested finding out from HHS what happens to the letters and what could be done to maximize the chance that the Secretary will read them.
REPORTS FROM SUBCOMMITTEES AND WORKGROUPS
NHII Workgroup—Dr. Cohn
The Workgroup has been part of the recent work on the NHIN letter. The Ad Hoc Workgroup will hold a four-hour conference call on October 3 and another conference call for Committee members before presenting the letter to the NHIN Forum.
Subcommittee on Standards and Security—Mr. Reynolds
This Subcommittee was also part of the NHIN project. After the October hearing, it will focus on NPI and possibly develop a letter on NPI implementation. It is also planning four presentations on e-prescribing.
Subcommittee on Privacy and Confidentiality—Mr. Rothstein
The Subcommittee is planning two hearings, one following this meeting on the potential effect on non-covered entities of extensions of coverage of HIPAA or another law. A November 30 hearing will address research strategies to measure the effects of the privacy rule.
Subcommittee on Populations—Dr. Steinwachs
The Subcommittee will hold a workshop on September 18-19 on data linkages to improve health outcomes. It also has been moving ahead on exploring surge capacity and is working on ways to assess progress toward implementing the Vision for 21st century health statistics.
Quality Workgroup—Mr. Hungate
Mr. Hungate welcomed Mary Beth Farquhar as the new lead staff for the Workgroup, which is working with her on the AHRQ Quality Indicators project. The Workgroup may hold a hearing on the pitfalls and potential of the program.
This concluded the normal business of the National Committee, which immediately reconvened in a joint meeting with the NCHS BSC.
—JOINT MEETING WITH NCHS BOARD OF SCIENTIFIC COUNSELORS (BSC)—
INTRODUCTORY COMMENTS—Dr. Cohn and Dr. O’Neill
Following introductions around the room, the two Chairs described the functions of their respective advisory bodies and commented on the overlaps and synergies between them and the purpose of this meeting. They predicted that the day’s discussions would yield decisions about next steps to be taken jointly.
Dr. Scanlon, the NCVHS liaison to the BSC, commented that both bodies face the same challenge of having very broad missions and needing to be strategic to maximize their impacts. The two groups can reinforce each other in achieving a greater impact, a process that can be catalyzed by greater familiarity.
Dr. Elo, the BSC liaison to NCVHS, noted the importance of identifying overlapping issues and concerns in order to lighten their combined load rather than adding new work. She noted the relevance of the Subcommittee on Populations’ work on data linkages and the bearing of the work on privacy and the NHIN on the threats to the nation’s vital statistics system.
Dr. Sondik described the two bodies as “the two wings of the NCHS family” and said he hoped they would meet periodically. Introducing the next presentations, he noted the “opposing forces” of a desire to get vital information as quickly as possible, the potential offered by technology, and the constraints related to confidentiality concerns.
IMPLICATIONS OF CONFIDENTIALITY REQUIREMENTS IN NATALITY AND MORTALITY VITAL STATISTICS
STATE PERSPECTIVE—Steven Schwartz, Ph.D., NAPHSIS
Dr. Schwartz is the New York City Registrar and President of the National Association for Public Health Statistics and Information Systems (NAPHSIS). He began with a summary of the U.S. Vital Registration System, a state function operated cooperatively with the federal government. States voluntarily send data to NCHS, which pays for the data. The two functions of the System are civil registration and collection of public health data. There are 57 vital registration jurisdictions in the U.S.: the 50 states and five territories plus the District of Columbia and New York City, all represented in NAPHSIS. The System faces many new risks from identity theft, national security, and changing technology. There is no national law on data release, which is governed by state law. One of the challenges for NCHS is coming up with a national policy on data release, given the large differences among states with respect to openness or restrictiveness and the varying nature of birth and death certificates. In addition, national security legislation will tighten access to vital records and vital statistics data.
Vital statistics data are special relative to other public health data because inclusion in the database is mandatory and universal, these data are attractive targets for misuse, and there are serious consequences if people refuse to provide the data because they fear the risks. Dr. Schwartz highlighted three categories of challenge: balancing public health and research benefits with protections against the threats listed above; addressing the risks created by technology; and the weakness of current enforcement. The goal is to maximize the use of vital statistics data for public health purposes while protecting confidentiality and complying with state laws and regulations.
NCHS PERSPECTIVE—Charlie Rothwell, NCHS
Mr. Rothwell described three types of NCHS releases of vital statistics: monthly data based on counts from states; reports when 90% of the data are in; and final release of clean and complete data in public use files that are available to researchers and analysts. He then discussed the compromise that NCHS has reached with states because of the issues described by Dr. Schwartz and particularly to comply with state law. The public use file is now a national file with no geographic specificity. NCHS has come up with a two-tiered approach to information release that is more specific than the public use file. Federal employees and contractors can ask for more specific information, down to the county level and for exact dates. The requests are reviewed by state representatives and NCHS staff to determine if they are appropriate. Record keeping is now required. The same procedure is used for private researchers, who have to use the NCHS research data center (RDC) to use sensitive data. This requirement restricts researchers’ ability to use and analyze the data.
Mr. Rothwell said this “balancing act” is not ideal, but it is “what we could hammer out” with the states over the course of a year in order to be in compliance with state laws. He noted that his next presentation (see below) would further illuminate vital statistics issues.
Discussion
Members of both committees had questions for the presenters. Mr. Rothwell said the above-mentioned restrictions would not affect the National Death Index. He reiterated that the issue with public use files is less about the risk of identifying people than about complying with state law. Dr. Norwood commented that there are similar issues for federal statistics in general (e.g., unemployment insurance data) as for vital statistics. Mr. Rothwell commented that one problem is that once a file is on the Internet, “other people [than the original users] can use and abuse it” and they cannot be identified.
Asked by Dr. Cohn whether these changes will have a chilling effect on understanding the health of the population, he said he did not think so; other data sources remain, including states’ own publications of vital statistics data. He added that NCHS publications will not change.
Dr. Schwartz commented that there is an opportunity for leadership here to craft a model state law on data release. Mr. Rothwell agreed that there is an opportunity to educate states on the best way to compile and release data, including some that release information they shouldn’t.
On Dr. Cohn’s question, Dr. Sondik said there could be an impact in terms of the individual information needed for public health action. Joint action by federal and state government will be necessary to address this, for example to permit comparisons.
Mr. Scanlon pointed out that there is a similar balancing of confidentiality and data access in HIPAA.
ELECTRONIC DEATH REGISTRATION: RE-ENGINEERING STATE AND FEDERAL SYSTEMS—Mr. Rothwell
In most states, mortality data are provided by funeral directors and a certifying physician such as a coroner. The funeral director provides the demographic information and the physician provides cause of death. There are a variety of problems with the current process. The federal government wants to automate death data, and Electronic Death Registration is one of the first E-gov initiatives, called e-vital. The Social Security Administration has taken the lead, funding several states a year to automate the EDR process. However, while demographic information is moving more rapidly to SSA, this has not helped NCHS because it also needs the medical information. The slowness of reporting means that emerging public health issues are not evident.
NCHS has recently received funding to start implementing EDRs to supplement what the SSA is doing. The end result will be reporting just days after a death. There will be regulations in the next year to require states to provide information more rapidly, and states and localities are getting more automation. One of the constraints is limitations in the medical coding systems that provide multiple causes of death. Another issue is the need to put the medical and demographic data together quickly to determine its accuracy. One question entails what is the appropriate interface with physicians.
Once EDRs are in place, the federal government will have a complete record within a few days of the event and at the same time that the state health department has the information. Then the question is how to release the information. One issue is that the preliminary information will be so recent that there may be problems with its accuracy. There also will have to be a decision about what is “the official, final file” once data can be more easily updated and improved. Those are some of the challenges ahead that Mr. Rothwell said the two advisory bodies present could be very helpful in figuring out how to handle. He added that decisions also will have to be made about who has access, and under what conditions.
Discussion
Dr. Ryan expressed enthusiasm about these developments and commented on the potential uses of modeling to create estimates based on preliminary data and samples.
Dr. Steuerle pointed out the merits of determining what the two committees could do and each one’s relative advantage with respect to such an issue. Mr. Rothwell pointed out the relevance of NCVHS’s work on the EHR and the fact that birth and death are “the bookends.” In the long term, he said, there should be systems that “suck” EHR information into them in usable form. The committees can also work on promoting data quality with health care providers.
NEXT STEPS
Dr. Tang summarized the issues discussed above as 1) capturing the information correctly the first time, in a codified way; 2) staging the analysis; and 3) getting the information out and used while protecting its safety.
In the final discussion of possible next steps, the following ideas were put forward:
- Referring the issues to the NCVHS Subcommittee on Populations, in the context of its review of progress toward the Vision for 21st century health statistics and its work on data linkages;
- Bringing the issues forward at a higher level, possibly through a joint letter to the Secretary;
- Taking a look at the data user agreements;
- Pursuing the role of EHRs and the notion of overall EHR activity that includes vital statistics as an integral aspect;
- Getting this concept on AHIC’s radar screen;
- Supporting the Center’s role in bringing the states on board;
- Encouraging further research and work on best practices and model statistics laws; and
- Paying attention to cost, funding and resource use issues.
Finally, Ms. Greenberg suggested that the conveners of this meeting get together again by phone to talk further about next steps.
Dr. Cohn then adjourned the meeting.
I hereby certify that, to the best of my knowledge, the foregoing summary of minutes is accurate and complete.
/s/ 11/29/2006
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Chair Date