Department of Health and Human Services


June 21-22, 2017

Hubert H. Humphrey Building, Washington, DC


The National Committee on Vital and Health Statistics was convened on June 21-22, 2017 at the Department of Health and Human Services’ Hubert H. Humphrey Building in Washington, DC. The meeting was open to the public. Present:

Committee members

William W. Stead, MD, Chair
Bruce Cohen, PhD
Nicholas Coussoule
Llewellyn Cornelius, PhD
Linda Kloss, MA, RHIA, CAE, FAHIMA
Richard Landen, MPH, MBA
Vickie Mays, PhD, MSPH
Jacki Monson, JD (phone)
Bob Philips, MD
Helga Rippen, MD, PhD, MPH, FACPM
David Ross, ScD
Debra Strickland, MS
Roland J. Thorpe, Jr., PhD


Raj Chanderraj, MD
Alexandra Goss
Denise Love

Lead Staff

Rebecca Hines, MHS, NCHS, Exec. Secretary
Rashida Dorsey, PhD, ASPE, Exec. Staff Director
Lorraine Doo, CMS
Geanelle Herring, CMS
Maya Bernstein, ASPE
Kate Brett, Ph.D., NCHS


Debbie Jackson, NCHS
Katherine Jones, NCHS
Marietta Squire, NCHS
Geneva Cashaw, NCHS

Others (not including presenters) Michael Lincoln, VA (phone)

Jon White, MD, ONC
Jim Sorace, ASPE
Suzie Burke-Bebee, ASPE
Scott Shippy, CMS
Kari Yaksin, CDC
Vivian Auld, NLM
Kin-wah Tung, NLM
Katie Knapp, VHA
Jean Narcisi, ADA
Patrick Waller, Cambia
Margaret Weiker, NCPDP Charles Stellar, WEDI
Dan Rode, Dan Rode & Assoc/EHNAC
Reid Kiser, CAQH
Kelly Turek, AHIP
Gail Coker, BCBS


  • The Committee passed a motion approving a letter to the Secretary on the Health Plan Identifier (HPID).
  • The Committee passed a motion to approve the summary of the testimony from the 2016 NCVHS Hearing on Claims-based Databases.
  • The Committee passed a motion asking the Subcommittee on Standards, if consultations with key stakeholders show that concern is widespread, to draft a letter expressing support for the removal of the Social Security Number from Medicare cards but also voicing the Committee’s concerns about testing and proposing that CMS limit the initial roll-out and treat it as a pilot, deferring the national roll-out pending the results and any indicated corrections. This letter, which can also include any other measures the Subcommittee deems appropriate, would go to the Executive Subcommittee for final approval.


Welcome―Dr. Stead

Following introductions, Dr. Stead welcomed three new NCVHS members and asked them to briefly introduce themselves. They are:

  • Debra Strickland, MS, Senior Solution Consultant, CONDUENT Ms. Strickland has worked in the standards industry for 17 years.
  • Roland J. Thorpe, Jr., PhD
    Associate Professor and Director, Program for Research on Men’s Health, Johns Hopkins Bloomberg School of Public Health
    Deputy Director, Hopkins Center for Health Disparities Solutions
    Dr. Thorpe’s current research focus is population health with a focus on the health of black men.
  • Jacki Monson, JD
    Vice President, Privacy & Information Security Officer, Sutter Health
    Ms. Monson has expertise in privacy, information security, and compliance.

Dr. Stead announced that Dr. Evans has had to resign from NCVHS due to additional professional responsibilities. He thanked her for her contributions during her tenure on the Committee.

ASPE Welcome―Dr. Dorsey

After thanking NCVHS members for their service, Dr. Dorsey gave updates on ASPE leadership personnel, Reimagine HHS, and the 21st Century Cures Act. Highlights:

  • John R. Graham, the Principal Deputy Assistant Secretary for Planning and Evaluation, is the current Acting ASPE. (Dr. Graham attended this meeting on Day Two.)
  • Reimagine HHS, an initiative of Secretary Price, is guided by the principles of engagement, empowerment, service, performance, stewardship, and sustainability. The areas of focus are connected to the HHS mission. It is likely that data will play a role in this new initiative.
  • Two provisions of the 21st Century Cures Act have particular relevance for Data Council and ASPE’s Data Policy Division: Section 2013, on protection of identifiable and sensitive information; and Section 2014, on data sharing. There are also several provisions related to privacy. Dr. Dorsey said the Committee might want to ask for a briefing on the 21st Century Cures Act, and there might be ways NCVHS can advise the Department as it moves forward. Provisions relevant to the Office of the National Coordinator for Health Information Technology (ONC) and interoperability are also of likely interest to NCVHS.

Discussion NCVHS members had questions on data issues for NIH related to a change in the Common Rule, and on how NCVHS might be helpful to ONC related to its work on technology. Dr. Cornelius suggested that NCVHS connect with NIH FACAs about the first issue.


Mr. Landen reported on a presentation he made to the National Plan Automation Group on behalf of the NCVHS Standards Subcommittee. At their invitation, he updated that group of BlueCross BlueShield EDI professionals on NCVHS standards-related activities over the last year (since the last time he presented to them), particularly the Report to Congress and the plans for the Predictability Roadmap. He shared his impression that people in such positions are averse to “revolutionary,” disruptive technology that would necessitate major changes in the infrastructures of their organizations. On this subject, Dr. Stead stressed the importance of making data accessible and understandable outside of transaction products and processes and avoiding “pushing things through those pipelines”

Dr. Stead then reported that the letter and report are now ready to go to the Secretary. He thanked NCVHS members and staff for their hard work in getting through a backlog of Committee work in November and generating a number of NCVHS reports and letters.

Health Plan Identifier Hearing Recommendation Letter―Mr. Coussoule

Before presenting a letter drafted by the Subcommittee on Standards, Mr. Coussoule gave some background information and an overview of the letter. The Health Plan Identifier (HPID) was called for under HIPAA and subsequently by the ACA. NCVHS has held hearings to get feedback on it since 2010, at which industry has consistently expressed concerns about it. The fundamental point is that the payer ID used to route transactions is sufficient and a transition to HPID could create more problems than it would solve. He then presented the draft NCVHS letter, summarized its three recommendations, and invited comments. Several members suggested minor modifications to the letter. Following discussion, the Committee passed a motion approving the letter as edited.

Dr. Stead observed that this is a good example of interaction between NCVHS and the Department: HHS asked NCVHS to do this, and the Committee turned it around promptly. Ms. Hines thanked CMS for adeptly staffing the project.

Summary of 2016 Hearing on Claims-Based Databases―Dr. Phillips (slides)

An ad hoc NCVHS workgroup recently developed a summary of the testimony at an NCVHS workshop on all-payer claims-based databases (APCDs) that was held on June 17, 2016. The purpose of the hearing was to get input on policy and reporting issues, federal and state issues, and standards with respect to the

APCDs. The new summary provides a more thorough rendering of oral and written testimony than the original transcript summary that was posted on the NCVHS website. This evolving area remains on the Committee’s list of possible future work. The new summary is intended to provide an evidence base to help the Committee and others decide what else they might do in this area. NCVHS members suggested various modifications to the summary. After discussion, they agreed that it should be confined to summarizing the 2016 hearing testimony, with this defined framing made clear in the summary. Dr.

Phillips said the ad hoc workgroup would make the recommended changes and present the revised version on day two of this meeting.

Members then discussed whether the Committee should do anything further with respect to APCDs. The topics that arose in the hearing included common data layout efforts, a federated platform, and inclusion of federal claims databases such as Medicare, the VA, and TriCare. In a round-robin approach on this question, the following questions and topics were raised and discussed:

  • What is being asked of NCVHS, and by whom? Do CMS and/or other HHS agencies want NCVHS to take this on?
  • On the Committee’s role in the current environment: HHS has a potential pivotal role, and thus NCVHS does, with respect to APCDs―e.g., related to standardization, potential uses of the data to understand and promote population health, access to/availability of the data, and financial support for the entities working on APCDs at the state level.
  • Forms of NCVHS involvement include these options:
    • A single watchdog giving periodic updates
    • A very targeted hearing, e.g., on standardization and data access
  • Merits of aligning with the new emphasis on federalism
  • Opportunities to expand APCDs to include other federal claims data (e.g., Medicare, Medicaid, VA, Tri-Care)
  • The place of APCDs in the larger data ecosystem
  • For maximum impact, should NCVHS address the tactical challenges of execution or reflect on policy challenges?
  • Questions of timing and priorities

Dr. Stead proposed asking the Subcommittee on Population Health to consider a focused approach that aligns with the federal role in supporting federalism and takes into consideration the activities in this area since the 2016 hearing. Among other suggestions discussed – an exploration as to whether available Federal data are fully utilized in this arena, and looking at APCDs in the broader context of the data ecosystem. The resonance with the NCVHS project on Next Generation Vital Statistics were noted.

Update on Predictability Roadmap Project―Mr. Coussoule

In 2017-18, NCVHS will assess the more efficient development and testing, adoption, implementation, and evaluation of HIPAA transactions and operating rules. Based on a review of opportunities for efficiency in the overall process and by the responsible organizations, NCVHS will develop recommendations to HHS aimed at achieving greater predictability in updating HIPAA transaction implementation specifications and operating rules. The intended recommendations will propose a predictability roadmap that would provide the healthcare industry with a degree of certainty in the timing of the development, adoption, or implementation of new or revised standards or operating rules as required under HIPAA.

The Subcommittee on Standards has started to engage participants in the process and has scheduled conference calls in July to get feedback; on this basis, the Subcommittee will craft an agenda for a workshop scheduled for August 21. It will decide on further steps after receiving the feedback through these initial steps. Ms. Kloss noted that the Committee embarked on this project in response to requests at multiple hearings from those responsible for implementing the impending changes. Dr. Stead added that the expected input about the feasibility of implementation will reveal something about “what size effort can be moved through such a pipeline,” and whether parallel pipelines are needed. Members commented further on the enormous complexity of the system and the industry’s need for predictability.

Health Terminologies and Vocabularies―Ms. Kloss and Panelists (slides)

Dr. Stead described this session as the beginning of the environmental scan for the Committee’s new initiative on health terminologies and vocabularies. Ms. Kloss framed the day’s agenda by describing the goals of the initiative, in which NCVHS will look at the landscape in order to advise the Secretary on:

  • The changing environment and implications for timing and approach to terminology and vocabulary standards adoption;
  • Needs, opportunities, and problems with development, dissemination, maintenance, and adoption of terminology and vocabulary standards; and
  • Actions that HHS might take to improve development, dissemination, maintenance, and adoption of standards.

The initiative will have two phases: first, briefings for the full Committee at this and the next one or two NCVHS meetings; and second, a study of opportunities for improvement, to begin in May 2018. The panels in the present meeting cover the federal family of terminologies and vocabularies; the panels in September will represent non-governmental developers and other stakeholders. A report will be developed summarizing the findings in phase 1. A final report and letter to the Secretary, with recommendations for HHS actions, are planned for the fall of 2018 or winter of 2019. Ms. Kloss cited the language in the NCVHS charter with which this project is consistent, and she noted the Committee’s long history of advising on matters of terminologies and vocabularies. She then welcomed the panelists.

Note: The rich details of the panelists’ presentations and their discussions with NCVHS members can be found in the presenters’ slides and the meeting transcript, both posted at <>.

Panel 1: SNOMED, LOINC, and RxNorm

  • Introduction―Patti Brennan, Director, National Library of Medicine (NLM) and Betsy Humphreys, Deputy Director, NLM

Dr. Brennan said the NLM welcomes the Committee’s interest in this topic because terminologies are essential to the data-powered health and health care that are now within grasp. Dr. Humphreys noted that HIPAA requires NCVHS to address clinical information standards. She cited a series of NCVHS reports and recommendations in which it has done so “at the right moment” and with positive impacts.

SNOMED-CT―Susan Roy, SNOMED CT Support Coordinator, NLM (slides)

SNOMED CT is a clinical terminology with global scope, covering clinical specialties, disciplines, and requirements. It contains more than 330,000 concepts in 19 domains. Its description logic enables automation of reasoning and analytical approaches to processing EHR data, and its extensibility mechanisms enable customization. It is owned by SNOMED International (IHTSDO), whose 30 international members (including the U.S./NLM, one of 9 charter members) provide the standards, guidelines, and specifications. NLM serves as the U.S. National Release Center. SNOMED CT International Edition is released in January and July every year, and NLM releases the U.S. edition twice a year in March and September. (Some users find this frequency of updates difficult to manage.) All downloads require a free UMLS (Unified Medical Language System) license. Maintenance occurs primarily in response to user submissions, as well as through collaborative agreements with other organizations. The recent incorporation of international advisory groups provides a new mechanism for consideration and testing of proposed revisions to guide SNOMED International. SNOMED CT is used in over 50 countries, and the U.S. Edition had almost 5,000 downloads in FY16. Finally, Ms. Roy described the relationships among SNOMED CT and ICD, LOINC, and GMDNA, and noted SNOMED International’s strong partnerships with a long list of SDOs and other organizations.

LOINC―Daniel Vreeman, Director, LOINC and Health Data Standards, Regenstrief Center for Biomedical Informatics (slides)

LOINC is a universal standard for identifying health measurements, observations, and documents. It is owned and maintained by the Regenstrief Institute, Inc., a non-profit organization, with significant support from NLM and other funders. LOINC currently has more than 84,000 codes. Its development and updates are community-driven, and it is free of charge to users. There are major releases in June and December every year, averaging 1400 new terms per release. In 2016, more than 50 organizations in 14 countries requested new terms. The LOINC Committee is the advisory body. LOINC has been included in NLM’s UMLS since 1998. The more than 47,000 registered users from 166 countries include federal agencies, reference labs, care organizations, insurance companies, health IT vendors, and more. LOINC is the national standard in more than 30 countries, and has been translated into 18 variants of 12 languages. LOINC has relationships with other SDOs and other key organizations in the U.S. Because the value of a standard is a function of the number of people who use it, Regenstrief provides a large set of tools and resources for implementers. It is committed to working with others to solve interoperability problems.

RxNorm―Patrick McLaughlin, Terminology QA and User Services, NLM (slides)

RxNorm is a drug terminology and nomenclature, developed and maintained by NLM, representing drugs from the prescriber’s point of view using concept unique identifiers (RXCUIs). It is derived from other commonly-used public and private drug terminologies, including FDA’s structured product labeling. It was released first in 2001 and most recently in June 2017 (with a total of 30,000 products, using 113,000 concepts). The monthly releases were downloaded over 5,200 times in FY16. The heavy use of RxNorm is partly the result of Meaningful Use. Mr. McLaughlin showed a graphic of the associative relationships among the concepts. Monthly releases and weekly new drug updates from SPL are available through downloads, APIs, DailyMed, the RxNav browser, the RxMix data processing tool, and other formats. For maintenance, RxNorm acquires most data sources monthly but FDA SPL daily. The editing uses source codes and descriptions, NDCs, and SPL text. Major editorial policy changes are informed by user feedback, NCPDP, and other stakeholders.

The UMLS Metathesaurus―Dr. Humphreys, NLM

The UMLS Metathesaurus is a concept-based method of identifying “the things that mean the same thing” across a large number of different vocabularies and classifications. It has been very valuable in enabling direct mapping as well as the analysis of textual data because it includes the codes from all the systems it is connecting. Thus it helps the user get from a single piece of data to related information in other places.

Panel 2: ICD-10 CM and ICD-11, ICD-10-PCS, and International Classification of Primary Care

Panel 2 described components of the international family of classifications overseen by the World Health Organization.

ICD-10-PCS―Pat Brooks, CMS, and Rhonda Butler, 3M (slides)The ICD-10 Procedure Coding System (PCS), used to code inpatient procedures, is maintained by CMS and updated annually on October 1. It has four key attributes: it is complete (all substantially different procedures have a unique code); expandable (the structure of the system allows incorporation of new procedures as unique codes); has a multi-axial structure (each axis/character specifies same type of information within a section and across sections to the extent possible); and uses standardized definitions (it defines a single meaning for each term used in the system). The ICD-10 Coordination and Maintenance (C&M) Committee discusses requested updates at its semi-annual meetings, and there are many ways to participate in these meetings. Changes to the PCS are posted in June and take effect on October 1. There is also a comment period. The C&M Committee considers written proposals, generally from organizations, and individual requests sent to CMS. The update process was subjected to a partial code freeze that lasted for four years. During that period, the C&M Committee considered the proposals and requests but saved them for implementation after the freeze was lifted. The two annual updates since the code freeze ended have been extensive because of the backlog, and the changes are being phased in gradually. This phased approach was supported by the AHA and the AHIMA.

ICD-10 CM and ICD-11―Donna Pickett, Chief, Classifications and Public Health Data Standards, NCHS (slides)

ICD (mortality) has been in use in the U.S. since 1900. The 10th iteration was adopted initially in 1989 and in the U.S. in 1999 (for mortality). The C&M Committee’s updating process for ICD-9 diagnosis and procedure codes began in 1985. WHO continues the revision process for updating ICD-10-CM and ICD- PCS while also actively developing ICD-11. All revision proposals go through the C&M process. Physician societies account for 95% of new ICD-10 requests. Regular updates are posted on the website, and there are pages on the NCHS website on the C&M process for the ICD-10-CM update.

An 11th revision is needed because ICD-10 is outdated; some chapters needed structural changes; and there is an increasing need to operate in an electronic environment. The revision process for this was launched in April 2007, and the current schedule projects submission to the World Health Assembly in May 2018. It was decided, after much debate, to create a joint classification for mortality and morbidity, with shared maintenance. Ms. Pickett described the development process for ICD-11 and the revision goals. The U.S. has several representatives involved, including Christopher Chute and Cile Kennedy. The ICD-11 Task Force, formed in January 2015, created a set of standards for the classification. Work on individual chapters and field testing and other assessments are ongoing. A rough estimate is that ICD-11 will be implemented a minimum of three years after it is approved by the World Health Assembly. Ms. Pickett stressed that “2018 is more of a start of the road,” not the end. She outlined some of the structural changes in ICD-11, which has a new content model. Finally, she commented on the implications of these developments for the US and NCVHS, based on past experience, and stressed that “we have our homework ahead of us” to lay the groundwork for a smooth transition to ICD-11.

  • International Classification of Primary Care (ICPC)―Robert Phillips, American Board of Family Medicine and NCVHS

The ICPC is a biaxial, alphanumeric classification of primary care problems and related actions. The two axes are chapters and components. Its 17 chapters are based on body systems, and there are seven components (e.g., symptoms and complaints and specific diagnoses) in each chapter. The patient voice is incorporated in the reason for encounter, and the classification accommodates social problems. It is organized, uniquely, into episodes of care and thus can track the process of care over time. It is a lumping, not a splitting, system, and has roughly 1300 codes. It is produced by the World Organization of Family Physicians (WONCA) and was first published in 1987 by Oxford University Press. The second revision, published in 1998, was accepted within the WHO Family of International Classifications. The third revision is in development. It is not a terminology but is mapped to standard terminologies and classifications. It makes it possible to map to other classifications or terminologies and produce data needed for various purposes while also maintaining the data system for one’s own purposes. ICPC offers the basis of a primary care data model, but “it is not the only way in.”

Summary and Reflections

Dr. Stead characterized the foregoing presentations as painting a picture of many efforts making great progress in incorporating similar techniques and approaches to address multiple purposes, at a time when the scope of the data needed to understand health and health care is exploding. One of the tensions for NCVHS to work out in its environmental scan is how far to reach into the future to gain perspective on present developments with respect to future needs and potentialities. “There are ways to create unifying frameworks, if we want to go there”; he encouraged keeping them in mind as the Committee moves forward.

Dr. Brennan asked the Committee to think about the dimensions of health that must be represented in understanding the health of a society, defined broadly. She also asked what research agenda NLM might carry out to ensure that the standards investments achieve what is needed for the health of the society. Dr. Cohen responded by describing the Committee’s many years of work on measuring population health, culminating in the Measurement Framework for Community Health and Well-being that integrates many of the factors discussed today. He invoked a vision of applying the level of detail and attention typical of NLM work to understanding what makes populations healthy. Dr. Brennan said she had reviewed the Measurement Framework and was excited about it; she imagines an “infrastructure for health” that uses terminologies, technologies, and other resources in service of the health of societies.

Update: Next Generation Vital Statistics―Dr. Cohen and Dr. Ross

The Subcommittee on Population Health will hold a two-day hearing on September 11-12 to address the fact that the vital statistics system faces serious structural and resource challenges. The guiding question and vision for the hearing is, How do we transform a vulnerable federated data collection network into a robust, timely, integrated, sustainable, and multipurpose information system that meets everyone’s needs? Day one of the hearing will provide a level-set; on day two the participants will review the vulnerabilities and challenges to the current system and explore potential solutions and opportunities. He referred members to the one-page summary of the hearing. Dr. Ross, the hearing co-chair, stressed the need to

identify the value proposition for the vital statistics system in terms of how it can help the federal government do what the Constitution charges it with doing. The hearing will help identify how to “make more power out of the information” being collected, and clarify the degree to which the information flow to the Federal government needs to be supported.

There being no public comment, the Committee recessed until the following day.


Work Group on Data Access and Use―Dr. Stead, Dr. Mays

Dr. Stead began the meeting by acknowledging and celebrating the Work Group on Data Access and Use, which was established in 2012 within NCVHS and was helpful to HHS with respect to issues related to open data and changing technologies. The Work Group will sunset when its members’ terms expire in August of this year, and Dr. Stead took the opportunity to thank the members and their current chair, Dr. Mays, for their service. Dr. Mays said the Work Group did trouble-shooting and special projects for HHS, most recently recommendations on She added her thanks to the members for their service and to the National Committee on Vital and Health Statistics for welcoming and listening to them.

Action: 2016 APCD Hearing Summary―Dr. Phillips

Dr. Phillips briefly reviewed the changes made to the hearing summary in response to the previous day’s discussions. After a few further edits, the Committee passed a motion to approve the summary. Dr. Phillips stimulated further discussion by asking members to comment on how the Subcommittee on Population Health might continue to work in this area. Dr. Cohen identified two possible paths: exploring expanding access to federal claims databases, and focusing on state-level APCD issues around standardization. Dr. Stead proposed a third option: doing an environmental scan around the data sources available for providing a picture of population-level health, health services, and changes in health. Others noted that these data sources could be used to populate the Measurement Framework, which defines the scope of the data. Dr. Mays suggested beginning the process with assessment to identify the problems to be understood.

Follow-up on the SSN Removal Initiative―Lois Serio, CMS, and others

The Medicare Access and CHIP Reauthorization Act [MACRA] of 2015 requires CMS to remove SSNs from all Medicare cards by April 2019. A new Medicare Beneficiary Identifier [MBI] will replace the SSN-based Health Insurance Claim Number [HICN] on the new Medicare cards for Medicare transactions such as billing, eligibility status, and claim status. The transition process is to begin in April 2018. Ms. Serio presented to the full Committee in February about the CMS project to remove the Social Security Number (SSN) from Medicare cards (the “SSN RI” initiative). She returned to this meeting with subject matter experts Diane Kovach and Patricia Rodgers to answer members’ questions and concerns. (Please refer to the transcript for the technical details.)

Some of the Committee’s concerns relate to the impacts of the change on research and on clinical care. The overarching issue that arose for the Committee concerned the lack of a plan to do a test roll-out and end-to-end testing to determine the impact of the intended changes on the broad spectrum of affected systems, including the provider ecosystem. Given the abiding concerns, Dr. Stead asked NCVHS members to comment. Ms. Kloss noted that the Subcommittee on Standards has proposed end-to-end testing as an overarching principle for any major release, and it is a best practice.

Following discussion, the Committee passed a motion asking the Subcommittee on Standards, if consultations with key stakeholders show that concern is widespread, to draft a letter expressing support for the removal of the Social Security Number from Medicare cards but also voicing the Committee’s concerns about testing and proposing that CMS limit the initial roll-out and treat it as a pilot, deferring the national roll-out pending the results and any indicated corrections. This letter, which can also include any other measures the Subcommittee deems appropriate, would go to the Executive Subcommittee for final approval.

NCVHS Strategic Plan―Dr. Stead

Members reviewed an NCVHS strategic plan drafted in November, 2015, to determine if it still applies. They approved the vision statement with a small modification. They decided to revise the mission statement, and were asked to send suggested language to Ms. Hines, who will draft a revised version and send it to members for comment. The subsequent version will be reviewed by the Executive Subcommittee in advance of review by the full Committee at its September meeting.

The Committee then reviewed a one-pager excerpted from the 11th Report to Congress (June 2014), to consider modifying it as a guide for the Committee now. Members suggested expanding the frame to include population health. After further discussion, they agreed to include this checklist with the strategic plan in the near term and to “park” the idea of metrics of NCVHS success for consideration when developing the work plan for 2018 or 2019.

Update from the NCHS Director―Mr. Rothwell

Mr. Rothwell thanked the Committee for its service and noted that the preceding discussion of CMS SSN RI illustrates “why we need advisory committees to wake us up and shake us up.” He then gave updates on current NCHS activities, budget issues, staffing, and future directions. NCHS still plans to redesign the National Health Interview Survey (HIS), but it will not be instituted until January 2019 to allow time to test the redesigned instrument. He expressed satisfaction with the direction in which vital statistics are headed, with vigorous young people in key positions in states who are “running toward” existing challenges and opportunities, combined with good collaboration among government agencies and increasingly rapid data release by NCHS. Regarding information acquisition from physicians and hospitals, he said that “electronic health records are right now our bane and our future”: the issue is how to standardize the data enough for it to be useful for health statistics. On NHANES, it remains the gold standard but NCHS is struggling with serious problems with response rates and reductions in staff.

The President’s budget had significant cuts for CDC and NIH, among others. NCHS’s appropriated dollars were cut $5 million, around 3 percent. The cuts to NIH and CDC budgets are also likely to reduce their ability to fund NCHS data collection. Still, he said he was thankful it wasn’t worse, though the budget is only enough to maintain the data collection systems and not to do anything new. The Center has been flat-funded for the last six years as costs have gone up. To protect the surveys, NCHS has a hiring freeze despite the fact that it is down 77 positions―15 percent under its FTE ceiling level. He named several key NCHS leaders who are retiring, and others (Dorothy Rice and Monroe Sirken) who recently died.

Regarding the future, Mr. Rothwell predicted that the recommendations of the Commission on Evidence- Based Policymaking, due in September, would have a strong impact. In the current period, the Data Council could play an important role, and efforts are afoot to reinvigorate it and “aim it toward whatever happens in the reimagining of our Department.” Finally, he stressed that “we need to change the way we’re doing business”; he sees this as an opportunity for NCVHS, the Data Council, and data-oriented agencies to “look at how we do business in the future.” The challenges include consolidating, standardizing, and using the information available in EHRs; ensuring the quality of e-vitals; and exploring ways to link data from these and other sources. “Somehow, we need to look at the future.”

ONC Discussion―Don Rucker, MD, National Coordinator for Health IT

Dr. Stead began the session by welcoming Dr. John Graham, HHS Acting Assistant Secretary for Planning and Evaluation. Dr. Graham took the opportunity to thank Dr. Dorsey and her staff for their work with NCVHS.

Dr. Rucker, the new National Coordinator, then described his longstanding interest in medical data and outlined ONC’s priorities. Given the difficulty of getting and analyzing data, much of ONC’s work is about freeing up data. Two large issues that are top ONC priorities are the usability of EHRs and interoperability. He commented on the perspectives of health providers and programmers, the “profound” biases in programming tools, and the many challenges related to interoperability. ONC’s mission and priorities are shaped by the 21st Century Cures Act, which mandates interoperability, not blocking information, and open APIs. Dr. Rucker noted that there are multiple user groups and constituencies, all with unique needs, including consumers/patients and entrepreneurs as well as health care providers.

In the discussion period, NCVHS members expressed particular interest in how the Committee can be of assistance to Dr. Rucker and the new ONC FACA, HITAC. NCVHS members welcomed Dr. Rucker’s suggestion that the two advisory committees hold a joint meeting to bring their joint perspectives to bear on achieving “demonstrated success in hooking up real-world, complex systems with real transmission of data.” He noted that the 21st Century Cures Act has a rank-order list of priorities for HITAC. NCVHS members also talked with Dr. Rucker about patient safety, coordination of the two FACAs’ work on privacy and security, cybersecurity, and the Department’s internal needs with respect to health information technology. Dr. Stead called attention to “data that doesn’t have to be pushed through the transaction pipeline” and suggested that “our sweet spot is actually outside of the transaction process.” Finally, Mr.

Rothwell stressed the importance of figuring out how the various advisory groups can know what’s going on and relate to each other so that HHS has the full benefit of their knowledge and advice.

Beyond HIPAA: Scoping―Ms. Kloss

The purpose of this session was to plan how to use the September meeting to launch the Beyond HIPAA project. This project explores the arena of health data outside of HIPAA. The goals are:

  1. To identify and describe the changing environment and the risks to the privacy and security of confidential health information, and to highlight promising policies, practices and technology;
  2. To lay out integrative models for how best to protect individuals’ privacy and secure health data uses outside of HIPAA protections while enabling useful uses, services, and research;
  3. To formulate recommendations for the secretary on actions HHS and other federal departments might take; and
  4. To prepare a report for health data stewards.

The project will be carried out in four phases, spread across 2018 and 2019: an environmental scan, which will generate a report on the findings; development of models and future scenarios for discussion at an invitational roundtable, generating a report describing a policy framework that includes benefits, levers, and relationships of policy alternatives; preparation of recommendations for the Secretary; and development of a report for the health care industry, data stewards and health data users, modeled on the earlier Stewardship Primer. The plan for September 2017 is a robust discussion on the privacy and security issues in the world beyond HIPAA.

As background, Rachel Seeger introduced ONC legal intern Shalley Kim for a brief report on her scan of the enforcement/governance framework of the Federal Trade Commission (FTC). This is a case study of the FTC’s broad enforcement authority in an area not covered by HIPAA. Ms. Kloss and Dr. Stead noted that this is a reminder that complementary legal frameworks are applicable in the world beyond HIPAA, reflecting awareness of the risks and possible remediations. Ms. Seeger said ONC did a cross-walk with NIST on the cybersecurity framework, and NIST has done a lot of innovative work in this area. Dr. Stead noted that the Committee’s challenge with this project is how to constrain the scope while remaining broad. He suggested using the Cybersecurity Task Force report as one of the building blocks. He later suggested broadening the frame from “law” to “levers.” Dr. Cohen suggested including in the scope the unintended consequences of the constraints imposed by HIPAA. ONC also has looked at the privacy and security framework of the NIH precision medicine initiative, which Ms. Seeger commended to the Committee as a good model.

It was agreed that Beyond HIPAA must look beyond health care, that the project will review the model and conclusions of the Cybersecurity Task Force, and that there will be a panel on the governance models and legal frameworks of the FTC, FDA, and perhaps NIH All of Us. The hearing will also feature an overview of the risks beyond cybersecurity, from a thought leader, and Ms. Kloss asked members to suggest speakers.

Having concluded this business, the Committee briefly returned to the plans for the terminology and vocabulary project – their discussion focused on what needs to be done to prepare for the transition to ICD-11. Ms. Strickland suggested encouraging the Subcommittee on Standards to pursue the issue and to work in collaboration with X12 if that is determined to be appropriate.

Workplan Discussion and Next Steps―Dr. Stead

The Committee then looked at the work plan for the rest of 2017 and 2018. Among other things, they created a “candidate items queue” for possible future projects of the Subcommittee on Population Health that are not on its current list. They also planned aspects of the September meeting agenda. Dr. Stead said that in the future, the HHS briefings portion of full Committee meetings would be reserved primarily for HHS activities aligned with NCVHS projects. Dr. Dorsey said she would work with the Committee on how to add 21st Cures and NIH to the agenda. The topic of ‘accounting for disclosures’ was penciled in on the Privacy Subcommittee’s list of candidate items. Dr. Stead asked as a regular discipline that subcommittees develop a scoping document on each of their planned projects that are listed in the Committee’s workplan.

Public Comment

Ms. Hines read a message from Dr. Eric Rose, Vice President of Terminology Management at Intelligent Medical Objects, calling the Committee’s attention to an issue of concern regarding the impending 2018 update of ICD-10 PCS suggesting this as an appropriate topic for the Committee.

Dan Rode thanked the Committee for the documents made available to the audience, and asked that they be made available ahead of the meeting. In addition, he made these requests related to communication, accessibility, and informing key stakeholders:

  • Make discussions available for people to listen to online
  • Get the word out about the Predictability Roadmap project
  • Make the NCVHS work plan or an overview available on the NCVHS website.

Asked for his ideas on how to effectively inform key stakeholders of such matters, Mr. Rode suggested disseminating the foregoing information through the liaisons and using press releases to announce important NCVHS events, projects, and products. He noted that simply making the work plans available will alert people to the Committee’s projects.

After thanking the NCVHS staff for their invaluable meeting support, Dr. Stead adjourned the meeting.

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