Department of Health and Human Services
NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS
September 13-14, 2017
Hubert H. Humphrey Building, Washington, DC
Note: Please refer to the transcript and slides for details on this meeting, posted at ncvhs.roseliassociates.com. Transcripts are linked to the meeting calendar; slides are linked to the agenda.
The National Committee on Vital and Health Statistics convened September 13-14, 2017 at the Department of Health and Human Services’ Hubert H. Humphrey Building in Washington, DC. The meeting was open to the public. Present:
William W. Stead, MD, Chair
Bruce Cohen, PhD
Llewellyn Cornelius, PhD
Linda Kloss, RHIA, CAE, FAHIMA
Vickie Mays, PhD, MSPH
Helga Rippen, MD, PhD
David Ross, Sc.D.
Debra Strickland (phone)
Raj Chanderraj, MD
Richard Landen, MPH, MBA
Bob Phillips, MD
Lead Staff and Liaisons
Rebecca Hines, MHS, NCHS, Executive Secretary/DFO
Maya Bernstein, ASPE
Kate Brett, PhD, NCHS
Lorraine Doo, CMS
Debbie Jackson, NCHS
Katherine Jones, NCHS
Marietta Squire, NCHS
Geneva Cashaw, NCHS
CAPT Chris Jones, ASPE
Vivian Auld, NLM
Rachel Seeger, OCR
- The Committee passed a motion approving a letter to the Secretary on the CMS transition from Social Security Numbers to a Medicare Beneficiary Identifier, and authorizing staff and Subcommittee co-chairs to decide on the placement of recommendations in the letter.
- The Committee passed a motion approving the revised NCVHS Strategic Plan.
Agenda Review and Welcome―Dr. Stead and Ms. Hines
After Dr. Stead welcomed the Committee and reviewed the agenda, Ms. Hines invited new member Jacki Monson, present in person at her first NCVHS meeting, to introduce herself. Ms. Monson is the Chief Privacy and Information Security Officer for Sutter Health and brings cybersecurity expertise. She has joined the Subcommittee on Privacy, Confidentiality and Security.
As background, Dr. Stead noted that in keeping with its charter, NCVHS actively encourages outreach to catalyze the work of different organizations that furthers the NCVHS mission. Members then provided the following updates:
- Hines explained the Committee’s relationship with the NCHS Board of Scientific Counselors, to which Dr. Phillips serves as the NCVHS liaison.
- Stead reviewed several new appointments: Jerome Adams has been confirmed as Surgeon General; Stephen Parente has been nominated as HHS Assistant Secretary for Planning and Evaluation; and Nancy Potok was appointed Chief Statistician for the U.S. Ms. Hines suggested that the Committee ask for a briefing from Dr. Potok.
- Goss reported that at their invitation, she presented an overview of NCVHS to the National Uniform Claims Committee in August, and talked with them about opportunities to promote greater awareness of NCVHS, starting with a presentation to the WEDI conference coming up in December.
- Cohen gave an update on the public-private partnership being led by Dr. Soma Stout, Executive Director of 100 Million Healthier Lives, to carry forward the NCVHS Measurement Framework for Community Health and Well-being. This group has held two meetings, and there is considerable interest in developing and implementing the NCVHS Framework, starting with an effort to catalog existing measures for the domains and sub-domains. Dr. Stead suggested taking a “Wiki-like approach” to that task.
Predictability Roadmap―Ms. Goss and Mr. Coussoule
Ms. Goss explained that NCVHS has received feedback from the industry about their need for greater predictability in anticipated changes related to administrative simplification. In response, NCVHS has undertaken this project, focusing on transactions and operating rules. Mr. Coussoule added that there are both pace and manageability issues. The Subcommittee on Standards has worked for a year on gathering information and planning this project, producing an “impressive grid” of information and supplementing it with conversations with stakeholder organizations. It then held a workshop on August 21. Ms. Goss said it brought “a breath of fresh air into the conversation” using the Appreciative Inquiry methodology, which Ms. Doo briefly described for the Committee. The key finding, Ms. Goss said, were that “we do need to change the system,” including these: streamlining the process, and doing frequent small changes rather than many at once over longer time intervals; changing federal processes; ensuring sufficient representation and engagement of all impacted stakeholders in developing and updating standards and operating rules, and doing so “early in the game”; and improving data cohesion.
As next steps, the Subcommittee plans more extensive outreach, including to the users of standards and operating rules, as well as obtaining validation and more input from workshop participants.
Dr. Stead proposed turning the “pallet of good ideas” into a set of alternatives, leading to a “straw person” of what a predictable system at pace would look like, and asking people to react to the alternative and straw person. Ms. Goss said the Subcommittee planned a series of meetings through which it would come up with options for each of the themes, followed by additional outreach.
Draft Letter on Social Security Number Replacement Initiative, AKA “New Medicare Card Project”
Mr. Coussoule presented a draft letter to the Secretary conveying the Committee’s feedback on the CMS plan to transition from using Social Security Numbers (SSNs) on Medicare cards, replacing them with a new Medicare Beneficiary Identifier (MBI). He described the letter section-by-section and invited feedback, which members discussed in detail. Ms. Goss explained that the Subcommittee drafted the letter after issues were raised by industry members following a briefing at the June NCVHS meeting. In view of the time-sensitive nature of the issue, the Committee agreed that a focused letter that outlines areas in need of immediate attention with emphasis on the need for immediate action on outreach, education, and testing would be most effective. Broader issues, notably those related to the potential downstream impact on the many systems that rely on the SSN, will be addressed in other ways.
The Committee then passed a motion to approve the letter and authorized staff and Subcommittee co-chairs to decide on the placement of the recommendations in the letter. The final version of the letter will be posted on the NCVHS website.
The Committee then considered the broader areas of concern raised by this impending change: what will happen to the legacy data that includes SSNs; the impact on the range of other uses of the SSN; and the potential confusion that this change may cause to Medicare beneficiaries. This led to identification of several questions for CMS about their thinking and planning for the transition. On the possibility of further NCVHS recommendations on this subject, Dr. Stead suggested further fact-finding and conversation before doing so.
NCVHS Strategic Plan―Dr. Stead
Members reviewed a revised version of the NCVHS vision and mission statements and strategic goals and objectives drafted by the Executive Subcommittee. After approving the vision and mission statements as drafted, the Committee discussed the goals, clarifying and refining the language in some areas and ultimately approving all four goal statements once modified. They subsequently reviewed and discussed the objectives for each one, and ultimately approved the objectives for goal 1, goal 2, goal 3, and goal 4. Finally, they passed a motion accepting the NCVHS Strategic Plan.
Health Information Privacy and Security Beyond HIPAA―Ms. Kloss
Ms. Kloss described this session as the kickoff of the NCVHS “Beyond HIPAA” project, which is led by the Subcommittee on Privacy, Confidentiality and Security. She introduced former NCVHS member (1996-2000) and Privacy Subcommittee chair Bob Gellman, who is under contract to chronicle what NCVHS learns through its environmental scan of the issues beyond HIPAA and to write a report on that basis. He asked members and others to send him relevant materials. To date, the Subcommittee has looked at past NCVHS reports as well as the work of other groups, including the FTC’s report on big data. In the environmental scan portion of this initiative, it wants to identify and describe the changing environment and the risks to privacy and security, highlighting promising policies, practices, and technologies. It plans to update some of its prior work, to lay out integrative models of how best to protect individual privacy and secure health data outside of HIPAA protections, and formulate recommendations for the Secretary.
Ms. Kloss then introduced the panelists for this environmental scan session as follows:
- The Internet of Things―Jeremy Epstein, Deputy Division Director, Computer Network Systems, National Science Foundation
Mr. Epstein noted that the Networking and Information Technology, Research and Development National Coordinating Office Privacy Interagency Working Group (NITRD NCO IWG, AKA “the privacy group”) is another group that might be asked to present to NCVHS. He talked about the “Internet of things,” i.e., the devices that store and/or transmit unique information about the user. The “quantified self” movement is a related phenomenon.
- Stephanie Devaney, Deputy Director, All of Us Research Program, NIH (slides)
This NIH program is recruiting a million or more diverse U.S. volunteers in order to create a biomedical data resource to inform research studies and accelerate individualized medical breakthroughs on a wide range of health conditions. Participants will be partners in the program and have access to the information and data about themselves. The program adheres to established transparency, privacy, trust, and security principles. It was initially funded under the Precision Medicine Initiative, and has some funding through the Cures Act. A national launch is slated for early 2018.
- Nicole Gardner, Vice President, IBM Services Group
Ms. Gardner congratulated NCVHS on “starting to tackle what is becoming every day a more and more complex question.” She noted that her CEO calls data “the currency of the future,” typifying “how commercial entities think about data.” She pointed out that the volume of data is accelerating, and most of it is unstructured (without a format), not static, and lacking in legal boundaries, governance structures and policies. She stressed the importance and difficulty of even defining “health data,” in view of the many determinants of health. After commenting on the “wild west” nature of privacy issues at present, she described a few of the practical approaches to privacy and security such as Blockchain and facial recognition.
- Fatemeh Khatibloo, Forrester Research (slides)
Dr. Khatibloo said she brings the consumer and citizen perspective to this conversation. People understand the value of the tools and technologies that enable and empower them with their health data. A sampling of U.S. adults online found that 24 percent are actively interested in sharing their fitness-wearable data with their physicians; 55 percent are comfortable with the idea of it; and 25 percent are not comfortable doing so. At the same time, half of U.S. consumers―including millennials and teenagers―are worried about the privacy of their health data. She characterized this apparent disconnect as a “privacy and personalization paradox.” Further, people do not understand what HIPAA is and what protections it affords, nor the consequences of putting their health information “out there.” She advocated protecting people by requiring apps and devices to become HIPAA-compliant, “even if it means sometimes having fewer features,” and she proposed six specific approaches to amending HIPAA:
- Expand the definition of PHI to include wellness and behavior data;
- Further define specific classes of PHI, based on their potential risk and sensitivity;
- Require proportionally appropriate protection and handling of each class of data
- Limit the use of sensitive data, irrespective of provider or practitioner;
- Subject all firms collecting health data to the same privacy and security standards;
- Provide meaningful control over health data to the individual
The Committee then talked at length with the panelists about what forms of additional protections are needed and feasible, the implications for education and consent, and what an implementation process might look like.
- Cora Han, Division of Privacy and Identity Protection, Federal Trade Commission (FTC) (slides)
Ms. Han, an attorney with the FTC, gave a brief background of the Commission and described some of its initiatives in this area, using mechanisms including law enforcement, policy initiatives, reports, consumer education, and business outreach. The area of consumer-generated information outside of HIPAA has been an area of FTC focus for several years. She reviewed the risks and challenges in this area. The FTC’s enforcement authority under Section 5 of the FTC Act extends to both HIPAA and non-HIPAA covered entities, with limitations that she outlined. The FTC works closely with the HHS Office of Civil Rights in areas of concurrent jurisdiction. It also enforces sector-specific rules and statutes in the privacy and data security area, notably its health breach notification rule. The FTC’s report, “Big Data: A Tool for Inclusion or Exclusion?” addresses both the benefits and risks of big data.
- Jacki Monson, Sutter Health and NCVHS member (slides)
Ms. Monson serves on the HHS Healthcare Cybersecurity Taskforce, which focuses on health care. It regards cybersecurity as “an industry problem,” not just a government problem, and has recommended actions that health care can take to solve it. The Taskforce’s report stresses the importance of keeping patients safe and solving the cybersecurity crisis together, and it outlines six “imperatives” for doing so related to leadership and governance, security by design, workforce, awareness and readiness, and information-sharing.
In response to a question, Ms. Monson said she didn’t think there had been enough attention given to the Taskforce’s recommendations, and she commented on what additional levers are needed. Committee members discussed the process of creating a culture of security; the particular challenges faced by smaller providers and practitioners; the challenges of working with vendors; and other related topics. Dr. Stead praised the fact that the Taskforce “labeled this as a patient safety issue,” and the group discussed the risks to patients and the need for prevention. They also considered the need for solutions that do not depend on national legislation or actions by federal agencies. Finally, the participants responded to a query from Ms. Kloss about what else the Committee should be learning for its environmental scan on this topic.
The forthcoming NCVHS report, “Health Information Privacy beyond HIPAA: A 2018 Environmental Scan of Major Trends and Challenges,” will synthesize the inputs and findings from this session.
Next Generation Vital Statistics Hearing―Dr. Cohen (slides)
Dr. Cohen said the NCVHS hearing on the Next Generation of Vital Statistics, held September 11-12, was “an incredible learning experience for everybody.” A broad array of experts from multiple sectors testified and participated. The objectives for the hearing were to identify the elements of vital statistics, understand their uses, assess their current status, and consider what is needed to protect and improve the system. The guiding question was, “How do we transform a vulnerable, federated data collection network into a robust, timely, integrated, sustainable, and multipurpose information system that produces timely data and information flows?”
The hearing testimony highlighted the multiplicity of uses of individual birth and death certificates and of the aggregate vital statistics derived from them. It also surfaced concerns about timeliness and other aspects of data quality; the complexity of the diverse vital records systems in the 57 U.S. registration jurisdictions that are part of the federated system; the constraints imposed on data access and sharing by disparate state laws and regulations; the unpredictability and inadequacy of funding, exacerbated by unfunded mandates; and a number of other issues. Different stakeholders representing state, Federal agency, commerce, and research articulated concerns from their varied perspectives. The discussions over the course of two days also generated many ideas for envisioning and moving toward the next generation of vitals.
Dr. Ross commented on the need for an analysis of the users and uses of vitals data and the related money flow, to inform the development of a more effective business case/cases for vitals. Others stressed the importance of linkages, the need to build a more compelling case for vitals, the sensitivity of state-level perspectives, and the need for additional fact-finding and consultation. The Committee agreed that the next steps for NCVHS will include 1) a summary report of the hearing, 2) commissioning of an environmental scan as described above by Dr. Ross, and, at a later time, 3) a letter to the Secretary with recommendations. Ms. Goss observed that this initiative is part of the larger NCVHS conversation about its visioning work, which includes a focus on how to improve predictability in standards.
The Committee then recessed until the following day.
Commission on Evidence-based Policymaking (CEP) Report and Recommendations
―Lucas Hitt, CEP Deputy Executive Director, and Sherry Glied, CEP member (slides)
Dr. Glied noted that the CEP released its final report on September 7. Its members were in “overwhelming agreement on its final recommendations about how to improve the production and use of evidence and how to use evidence to improve the design and administration of Federal programs. The Commission was charged with figuring out how to improve access to data while protecting privacy and confidentiality. Five of the 15 commissioners were privacy experts. It held seven public meetings and three public hearings over an 8-month period, published a request for comments in the Federal Register, and held more than 40 other meetings. Early in 2017, NCVHS had provided input to the CEP to contribute to the Commission’s knowledge base from which to formulate recommendations. This input plus a long deliberative process led to 22 CEP recommendations in the final report. The major themes of the report and recommendations are improved access to data, stronger privacy protections, and greater capacity for evidence-building across institutions inside and outside government.
The Commission was asked to recommend for or against a clearinghouse, and decided there should not be a single clearinghouse or data warehouse for government data. To cite a few other highlights, regarding data access the CEC recommended the establishment of a National Secure Data Service (NSDS)―”a new actor in the world of evidence-building”―to facilitate access to data for evidence-building while ensuring privacy and transparency. On privacy protections, it recommended requiring comprehensive risk assessments on de-identified confidential data intended for public release, among other measures. On strengthening the Federal capacity for evidence-building, it recommended identifying or establishing a Chief Evaluation Officer in each department to coordinate internally and collaborate with other departments. Another set of recommendations concerned increasing the use of state-collected administrative data to supplement the use of statistical data.
In conclusion, Dr. Glied said the CEC has gotten a lot of positive feedback on the report, but knows implementation and impact will take time. Mr. Hitt announced that the Bipartisan Policy Center has received funding to “carry the Commission forward,” and has hired CEC policy director Nick Hart to continue the work.
Dr. Cohen noted the complementarity of the CEC report and ongoing NCVHS work on the future of vital statistics. Ms. Kloss asked about the Commission’s thinking about tools for risk assessment and de-identification. Dr. Mays noted the concerns about adequate attention to small and specific populations. Others explored the anticipated functions of the NSDS and possible approaches to filling state-level data gaps. Asked how NCVHS could help move the CEP’s recommendations forward, Dr. Glied pointed to unresolved issues about 1) a possible Federal role in the technology for privacy protection, 2) access to state data, 3) aligning existing confidentiality and privacy requirements with new ones, and 4) clarifying the connection between data and evaluation. Mr. Hitt emphasized the state data issue and opportunities for greater utilization of the federal statistical agencies. Finally, Dr. Stead praised the CEC’s overall approach of building up from a confidentiality framework.
HHS Leadership Updates
- NCHS―Charlie Rothwell, Director
Mr. Rothwell expressed strong support for the CEC report, and encouraged NCVHS to look at how it could facilitate work on it within HHS. He stressed the importance of getting outside data siloes and figuring out how to link information between agencies, illustrating his point with recent experience in linking NCHS survey data and HUD data. He observed that “the capabilities in the federal statistical system are great, but they are not even”; for example, there is great variability in how disclosure reviews are done. He called for a protected environment or “safe zone” where people and Congress are assured that risk is minimized as data are moved, linked, and analyzed. Now, he said, “we need to figure out how to begin.” He then commented on what this means for HHS. While noting that HHS provides a model in many respects, such as its Assistant Secretary for Planning and Evaluation and its Data Council, he added, “We have not been working together as a team.” He noted that the CEC recommends that OMB reorganize, and recommended bringing the statistical agencies closer to the Chief Technology activities of the departments.
- ONC―Elise Anthony, Director, ONC Office of Policy (slides)
Ms. Anthony gave an update on ONC’s work on the 21st Century Cures Act, particularly Title IV (Delivery). Because the Cures Act is multifaceted, ONC has been working on how best to implement what Congress has asked it to do, with a focus on interoperability and exchange and patient access. After commenting on the other sections of Title IV, she focused her remarks on Section 4003, “Transparent Reporting on EHR Transparency, Usability, Security, and Functionality.” Having closed out its previous FACAs, ONC is setting up the new unified Health IT Advisory Committee, which will focus both on policies and standards. It hopes to have it in place in the winter. The Cures Act also directs ONC to continue to engage with NCVHS.
Section 4003 charges the National Coordinator with convening stakeholders to “develop or support a trusted exchange framework.” ONC held a kickoff meeting in June to share information on existing networks; it then released a blog and opened a public comment period on the same subject, followed by a webinar. A draft on the Framework and Common Agreement is slated for release in early 2018, followed by another comment period, with final release planned for later in 2018.
NCVHS members commented on the linkage between this ONC work and what NCVHS is doing, and asked about the work on patient access. Ms. Anthony promised more information on the latter at another time, noting the “opportunity for collaboration with the Committee” in this area.
- Office of the Chief Technology Officer―Mona Siddiqui
The Office of the CTO is looking at how to leverage healthdata.gov, which has historically “lived in the CTO’s office,” by understanding the data assets across HHS and analyzing the barriers to data sharing. In response to a question from Dr. Stead, Dr. Siddiqui affirmed that this CTO effort links “really well” with the thinking of the Commission on Evidence-based Policymaking. Dr. Rippen called attention to recent NCVHS work on frameworks for summarizing and organizing data, and she encouraged Dr. Siddiqui to look at it. On request, Dr. Siddiqui then described the CTO’s thinking about improving data access and usability, which she said must begin with agencies sharing data with each other.
- Chris Jones, Director, Division of Science Policy, ASPE
Mr. Jones said ASPE is involved in the strategies for the Secretary’s top clinical priorities of addressing the opioid epidemic, serious mental illness, and childhood obesity. Science and Data Policy is leading the opioid initiative, as it has for several years. The first prong of the strategy in that area combines prevention, treatment, and recovery services, where significant investments are being made; the other prongs are targeting the availability and distribution of overdose-reversing drugs; improving public health data and reporting (with CDC as the primary funder of a new surveillance system); supporting cutting-edge research; and improving the practice of pain management.
On the 21st Century Cures legislation, which has more than 200 sections, ASPE went through a process to identify high-priority sections and specify what HHS players need to be engaged in the roughly 50 top priorities. The Strategic Planning System is being used to monitor implementation.
Dr. Stead asked Mr. Jones for input on how NCVHS can be most helpful to ASPE, given the highly interdisciplinary nature of the Committee, and Mr. Jones said ASPE would “provide that lens.” Ms. Love asked about facilitating collaboration between states and federal agencies around HHS strategies, which Mr. Jones said was the intention.
Dr. Cohen asked Mr. Rothwell to suggest ways for NCVHS to help move forward on the CEC’s recommendations, and he suggested relating directly to the Data Council, the CTO, ASPE, and the ONC Chief Information Officer to look at how to work together and make recommendations. He also reiterated his earlier points about improving data linkages inside and outside HHS, and suggested that NCVHS think about what information the Department should be looking at. Finally, he highlighted the concerns about the recent trend in flat funding for NCHS.
Dr. Ross commented on the finding from the recent NCVHS hearing on the next generation of vitals about the broad federal benefit and private industry benefit from birth and death data. He asserted that HHS “is going to have to put some money to vitals infrastructure” to realize the “huge potential.” Mr. Jones proposed that opioids are a potential lever for getting attention to better funding to improve cause of death data. Mr. Rothwell added that both state vital registrars and the medical examiner system need more support. Speaking more generally about the potential uses of statistics, he asserted that “people in my program and other programs in the Department have to think broader about their systems.”
Health Terminologies and Vocabularies Environmental Scan, Part 2 (slides)
―Ms. Kloss and Donna Pickett, Chief, NCHS Classifications and Public Health Data Standards
Ms. Kloss framed this NCVHS initiative as “a standards issue,” stemming from the part of the NCVHS charge related to uniform data standards and advising the Department on health data collection needs and strategies. She showed a slide documenting six relevant NCVHS letters or reports between 1998 and the present. The goals of this project are to take a contemporary look at the health terminology and vocabulary landscape in order to advise the Secretary on the changing environment; needs, opportunities and problems in this area; and actions HHS might take to improve development, dissemination, maintenance, and adoption of standards. The present discussion is part of the environmental scan, which began at the June NCVHS meeting with a review of terminologies and vocabularies developed, maintained, or disseminated by the federal government. A report will be developed based on the environmental scan.
Ms. Kloss presented a detailed matrix cataloging information on named standards and other WHO international classifications. She summarized the key issue categories as governance, coordination, development processes, maintenance processes, supporting technologies, research and evaluation, and uses; and she articulated questions in several of these areas plus dissemination. She then invited discussion about whether those are the right questions to advance the Committee’s thinking. Members and others shared their ideas. Asked to comment on ICD-11, Ms. Pickett said that its structure and content will differ from those of ICD-10, and the changes are necessary.
Ms. Kloss then outlined the planned next steps for this project in 2018 and early 2019 (see final slide, to which she added the UMLS). Members agreed to delve into this planning in their forthcoming discussion of the NCVHS work plan. Dr. Stead asked that the presentation on SNOMED-CT and LOINC in January elucidate the variation in uses of these systems. He congratulated Ms. Kloss and her colleagues for “turning this landscape into an organized view,” and expressed support for their planned next steps.
NCVHS Workplan Formulation for Remainder of 2017 and 2018
The Committee spent the remainder of the meeting being briefed on the plans of each of the Subcommittees and thinking together about the overall NCVHS work plan. They also discussed plans for the November virtual meetings.
Ms. Hines read a comment from Steve Lazarus, commending NCVHS “for taking prompt and direct advisory action to the Secretary regarding the need for industry-wide training partner testing and workflow redesign prep for the SSNRI change.” He expressed hope that the Committee would communicate the nuances of its discussion to Medicare decision-makers as soon as possible, and suggested “consideration of issuing cards to new beneficiaries only for the first 90 days and then evaluating the impact on the industry monthly as a way to prepare the industry and the public for the significant change.”
In conclusion, Dr. Stead thanked the NCHS staff―notably Ms. Squire, Ms. Jackson, and Ms. Jones―for organizing and supporting this meeting, and Subcommittee staff―Ms. Bernstein, Ms. Seeger, Ms. Beebe, Ms. Doo, and Dr. Brett―for enabling the Committee to be “unbelievably” productive. Finally, he expressed special thanks to contract staffer Jeannine Christiani-Mtui, on the occasion of her final meeting, for her “simply wonderful” service to NCVHS for the past 12 years.
He then adjourned the meeting.
I hereby certify that, to the best of my knowledge, the foregoing summary of minutes is accurate and complete.
/s/ March 7, 2018