Department of Health and Human Services


June 14-15, 2016

Capital Hilton Hotel, Washington, DC


The National Committee on Vital and Health Statistics was convened on June 14-15, 2016, at the Capital Hilton Hotel in Washington, DC. The meeting was open to the public. Present:

Committee members
Walter Suarez, MD, Chair
Raj Chanderraj, MD, FACC
Bruce Cohen, Ph.D.
Nicholas Coussoule
Llewellyn Cornelius, Ph.D.
Barbara Evans, Ph.D., JD
Alexandra Goss
Linda Kloss, M.A.
Richard Landen, MPH, MBA
Denise Love
Vickie Mays, Ph.D., MSPH
Michael O’Grady, Ph.D.
Bob Phillips, MD
Helga Rippen, MD, Ph.D.
W. Ob Soonthornsima (by phone)
William W. Stead, M.D.

David Ross, Sc.D.

Lead Staff and Liaisons
Rebecca Hines, NCHS, Executive Secretary
James Scanlon, ASPE, Exec. Staff Director
Terri Deutsch, CMS
Maya Bernstein, ASPE
Kate Brett, NCHS

Others (not including presenters)
Debbie Jackson, NCHS
Katherine Jones, NCHS
Marietta Squire, NCHS
Suzie Bebee, ASPE
Jean Narcisi, ADA
Gwyn Smith, Veterans Health
Dan Rode, consultant
Katherine Knapp, VA
Kelley Turek, AHIP
Steve Lazarus, Boundary Information Group
Gwendolyn Lohse, CAQH-CORE
Karim Georges, ONC
Charles Stellar, WEDI
Gail Kocher, BCBS
Michael DeCarlo, BCBSA
Margaret Weiker, NCPDP


Re: Recommendations for the Electronic Health Care Attachment Standard: The Committee unanimously approved this letter.

Re: Recommendations for the Proposed Phase IV Operating Rules: The Committee unanimously approved this letter.


Welcome and Introductions

After Dr. Suarez welcomed attendees and all paused to honor and remember the Orlando shooting victims, the participants introduced themselves.

NCVHS Member Updates

The following members recently made presentations about and/or on behalf of NCVHS (to):

  • Dr. Stead (to HHS Data Leads)
  • Ms. Goss (at the HIPAA Summit, Pittsburgh Business Group, House Legislative Forum)

Mr. Landen is scheduled to present to the National Plan Automation Group in September.

Updates from the Department

  • Jim Scanlon, ASPE

Mr. Scanlon reviewed recent personnel changes and commented on FY2017 appropriations and the 2018 budget, noting that this is a time of transition and the new president will probably present his/her budget in February 2017. The HHS strategic plan provides an umbrella for planning. Uninsurance rates are at historic low levels, and HHS continues to monitor the implementation and impact of health care reform using multiple data sources and types. HHS has an initiative to make the Research Data Center easier to use. The Assistant Secretary for Health, Dr. Karen DeSalvo, has been conducting listening sessions across the U.S. relating to the OASH Public Health 3.0 initiative, which is focused on both empowering and learning from local and community health initiatives with attention to all the social determinants of health (SDOH). The IT Policy Steering Committee has issued a policy of “data sharing first,” emphasizing that data sharing should be a priority and an assumption that guides decisions on data collection from the outset. The Data Council has created an administrative data working group to look at and promulgate best practices in that area. A law has created a Federal Commission on Evidence-Based Policy-Making, with an Executive Director and 18 members including privacy experts. It will be focused on all policy related to data, specifically exploring how to open up federal data sources for more useful analysis and research, will have a website, and is slated to operate for 18 months. Finally, ASPE has new projects on improving data on American Indian/Native American populations and in the area of criminal justice and SDOH metrics.

Discussion: NCVHS members had questions and comments on the new Federal commission and the latest uninsured rates.

  • Charlie Rothwell, NCHS

After thanking NCVHS members for their service, Mr. Rothwell gave a brief overview of NCHS and the surveys and vital statistics it oversees. Most of its funding goes to staff salaries (~500) and its data collection activities. He expressed some concern about appropriations for the FY2017 budget. He gave a brief overview of the redesign of the National Health Interview Survey now underway at NCHS, noting the challenges of shortening the survey without sacrificing key content in hopes of increasing response rates. Another area of change is the Health Care Surveys. (See the presentations on these topics below.) Regarding vital statistics, he pointed to the increasing timeliness of reporting and new ways of assuring data accuracy, thanks to strong state support. However, he also noted the growing pressure on NCHS “to share our information before it should be shared.” This pressure is testing the Center’s independence―a struggle that he called “a good thing” despite its challenges. Mr. Rothwell stressed the pressing need for the HHS/NCHS human resources system to adopt an attitude of active recruitment and “courtship” to bring in the next generation of staffers. He noted that this issue “affects all of government.” Finally, he described the HHS Research Data Center, which provides a safe space for data linkage. It is a collaborative effort of SAMHSA, AHRQ and NCHS.

Discussion: NCVHS members expressed great appreciation for Mr. Rothwell’s leadership and offered comments and questions on new forms of data collection such as mining community and state administrative data; a public education campaign to improve survey response rates; plans to access data from EHRs; the RWJF Data for Health report; the content of fast data releases; and new tools to enable state and local people to augment NCHS data.

  • Shana Olshan, CMS

Ms. Olshan began by reporting on CMS actions related to two recent NCVHS (ACA Review Committee) recommendations: the need for additional education, and the need to strengthen enforcement. In the first area, the CMS website has a new segment on administration simplification, on which it welcomes NCVHS feedback. This is the first phase of improvements. Regarding enforcement, CMS is releasing a new, more secure web-based enforcement tool, dubbed ASET-T, which allows individuals and organizations to file complaints on violations of HIPAA and ACA transactions, code sets, unique identifiers, and operating rules. Organizations can test their compliance using this tool. CMS is working hard on an attachment standard, and she expressed optimism that HHS would soon adopt such a standard. She reported on the latest recipients of the CMS Health Care Innovation Awards, and on the status of and savings from competitive bidding programs for Medicare durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) payments. Finally, Ms. Olshan said she is looking forward to the forthcoming NCVHS recommendations on attachments and Phase IV operating rules.

Discussion: NCVHS members asked about CMS responses to the other six NCVHS recommendations; noted the Committee’s forthcoming discussions about predictability, roadmap development, and other efficiencies; and asked about ICD-10 implementation, forthcoming CMS actions, BETOS codes, and plans to replace the SSN with a new number.

  • Elise Anthony, ONC (slides)

Speaking by phone, Ms. Anthony briefed the Committee on these topics: the recent ONC annual meeting, its recent rulemaking activities, the Health IT federal advisory committees, Health IT Zika response, the interoperability pledge, Health IT transparency, and the ONC patient engagement playbook. The rulemaking activities, carried out with ONC’s HHS partners, concern an update on health IT certification criteria (including items on social determinants), the enhanced oversight and accountability proposed rule (issued in May after consultation with developers), and the CMS MACRA/MIPS proposed rule. (Dr. Yong reported on the latter on day two.) ONC’s FACAs are looking at the health IT component of the MACRA proposed rule and the interoperable standard advisory, and the Interoperability Taskforce is developing recommendations. ONC has been working with CDC and developers on health IT to support CDC’s clinical guidance on the Zika virus. With the interoperability pledge, companies providing 90 percent of the EHRs used by hospitals and the top five largest health care systems in the US have agreed to implement core commitments on consumer access, no blocking/ensuring transparency, and standards. ONC’s Transparency Initiative provides new regulatory disclosure requirements for health IT developers that are applicable to all products certified to 2014 and 2015 Editions. It is making information available on the transparency website.

Discussion: NCVHS members had questions and comments about training on data collection; mHealth data; and Meaningful Use.

Subcommittee on Standards: Letters from February Hearing (slides) (Action Item) ―Ms. Goss, Ms. Deutsch

The February 2016 hearing on operating rules and attachments led to development of two letters with recommendations that were presented for action at this meeting. Both draft letters were posted in advance of this meeting, with opportunities for NCVHS members and stakeholders to comment.

Ms. Goss and Ms. Deutsch began with the letter on attachment standards, starting with background on the issue and the NCVHS review process. HIPAA stipulates the health care claim attachment as a transaction for which electronic standards are to be adopted. A rule proposed by HHS in 2005 was not published due to concerns about the maturity of the standard and the ability to implement it. NCVHS has held four hearings on the subject in the last five years and sent recommendations to the Secretary after each one. The letter submitted at this meeting combines previous recommendations along with the results of the recent hearing.

Ms. Goss summarized the points made in the draft letter and then read the 16 recommendations, inviting comments on each one. NCVHS members offered no comments on the letter. In conclusion, she stated the Subcommittee’s belief that a new NPRM is an essential activity to engage stakeholders, raise awareness, solicit comments, and create a glide path for implementation. The Committee will take action on this letter on day two of this meeting.

Turning to the second letter, on Phase IV Operating Rules, Ms. Deutsch provided background information. Operating rules are business rules that supplement other standards and define the business elements in the execution of administrative transactions. They pertain to infrastructure and business process. The authority resides in Section 1104 of the ACA. The Council for Affordable Quality Healthcare Committee on the Operating Rules for Information Exchange (CAQH CORE) is the designated authoring entity, and its participants vet the operating rules. Rules have been adopted in four areas and are proposed in four additional areas. The Subcommittee on Standards held hearings on Phase IV operating rules in February of 2015 and 2016.

Ms. Goss said the recommendations center on a strong case for voluntary adoption of the operating rules by industry. She then went through each of the recommendations, inviting further comment from members. None were offered. She added that late the previous day, the Subcommittee had received four new requests from CAQH CORE. The communication was shared with all NCVHS members. Dr. Suarez explained the NCVHS transparency policy and process, and said the Committee can consider the new comments in its final decision on the letter. Members reviewed and discussed the CAQH CORE requests and agreed to revisit some of them during the public comment period. All requests will be considered in the development of the final version of the letter, which will be presented for action on day two.

Briefing on the Public Health Landscape

Dr. Suarez said the following series of presentations would take NCVHS “back to its roots”―its work on vital and health statistics. Such briefings are planned for subsequent meetings, under the leadership of the co-chairs of the Population Health and Standards subcommittees.

  • NCHS Overview―Susan Queen, Ph.D., NCHS (slides)

Dr. Queen directs the NCHS Office of Planning, Budget, and Legislation. With her remarks, she said she hoped to raise awareness of issues for which NCVHS might be of help. The mission of NCHS is to provide authoritative statistical information that will guide actions and policies to improve the health of the American people. It is located within CDC, which also has programs, policy, and regulatory action in its mission, as does the Department. These differences create natural tensions that are common to all U.S. statistical agencies. NCHS collects data in five major areas: the National Vital Statistics System, the National Health Interview Survey (NHIS), the National Survey of Family Growth, the National Health and Nutrition Examination Survey (NHANES), and the National Health Care Surveys.

NCHS is one of 13 Federal Statistical Agencies, all housed within federal departments (unlike in some other countries), coordinated by the Chief Statistician who resides in OMB/OIRA. The system was set up in the U.S. Constitution, with oversight by Congress. Despite being “under a mantle of politics,” the agencies must operate in a manner that provides credible, relevant statistics and maintains public trust. Among other forms of guidance, OMB’s Statistical Policy Office provides guidance and has published statistical directives. The Committee on National Statistics (CNSTAT), which has published principles and practices for federal statistical agencies starting in 1992, has observed that these agencies need a strong measure of independence from political and other undue influences. Dr. Queen flagged independence as a core principle and recurrent theme and issue, given the “constant and increasing pressure” that statistical agencies face―for example, related to the timeliness of data releases.

Organizationally, NCHS is placed in essentially the fourth tier of the CDC structure. However, in 1995 the HHS Secretary designated the NCHS Director as Senior Advisor to the Secretary for health statistics; s/he reports directly to the Secretary on health statistics and to the CDC Director on NCHS operations. NCHS and CDC have a very positive working relationship. Dr. Queen then reviewed budgetary matters for 2016 and expectations for 2017. The Senate markup for 2017 cut NCHS by almost $4.4 million, even as CDC is charged with helping states to improve electronic death reporting and play other key roles, including those related to the new Commission on Evidence-Based Policy Making and to new uses of administrative data for statistical purposes. In the future, NCHS will focus on EHRs, improving survey response rates, the NHIS redesign, improving timeliness and quality of vitals, using administrative records and other data sources, and innovation. Finally, Dr. Queen reiterated the challenges related to NCHS independence as a statistical agency.

Discussion: The major topics in a rich discussion with NCVHS members included the role of NCHS in supporting innovation and methodological research; the need for proactive strategies to protect the Center’s appropriations; the potential for alliances with the states, which are facing similar challenges; and emerging trends in statistical data that offer NCHS opportunities for involvement in high-level discussions.

  • National Health Interview Survey―Marcie Cynamon, NCHS (slides)

Ms. Cynamon directs the NCHS Division of Health Interview Statistics. The NHIS has monitored the health of the US population since 1957 using in-person interviews by Census Bureau interviewers with an address-based, clustered national sample of housing units in every state (totaling 35,000 households). There are three modules―on the family, a sample child, and a sample adult. Data collection is continuous, generating quarterly and annual data files. NCHS has a robust early-release program on 15 key health indicators and health insurance coverage. Data are disseminated through many channels.

The goals of the NHIS content redesign that will be fielded in 2018 include improving the relevance of the covered topics, focusing on leading causes of morbidity/mortality, harmonizing with other federal health surveys, reducing respondent burden, and improving data quality. The idea is to use the redesigned version for 10 years. Ms. Cynamon showed a series of graphs showing the growing length of interviews over the years (to the current 100 minutes) and the corresponding decline in response rates. In addition to the declining response rates, interviewers cannot complete more than one interview a night, necessitating a larger and more costly workforce.

The redesigned version will have seven key content areas. Using a “quilt” or “crop rotation” format, it will have constant core questions; a second, “rotating core”; and sponsored supplements in 1- or 2-year modules. The last group of questions will take no more than 5 minutes. Sponsoring agencies, which have been supportive of these changes, have been asked to think about how to rotate content in and out. Proposed changes that have generated concerns among stakeholders include not using the NHIS to study rare events and eliminating the family questionnaire. The anticipated impact of all the proposed changes include improved data quality, an updated focus, a possible break in trends, more person-level information, and consistency in long-term planning. The redesign is being guided by literature review, extensive outreach to users, and consultations with technical experts

Discussion: Members had comments and questions about the rare event exclusion, alternatives to interviews, gender identity data, data continuity, piloting and monitoring, and complementary data sources.

  • Retooling the National Health Care Surveys in an Electronic World―Denys Lau, Ph.D., NCHS (slides)

Dr. Lau is Deputy Director of the NCHS Division of Health Care Statistics. He described how the National Health Care Surveys are leveraging the CMS Electronic Health Record Incentive Program. The four surveys in this family cover the spectrum of health care delivery systems: the National Ambulatory Medical Care Survey (NAMCS), National Hospital Ambulatory Medical Care Survey, National Hospital Care Survey (NHCS), and National Study of Long-Term Care Providers. Each survey is nationally representative and collects data from each sampled provider. They include data on both patients and encounters.

The NHCS (which replaces the National Hospital Discharge Survey) will be the first of the health care surveys to move to EHR-based data collection. This change will reduce the burden on providers, be more secure and timely, and provide greater clinical detail and depth as well as a greater volume of data. This is considered the right time to make the move because a critical mass of office-based physicians and acute care hospitals has adopted EHR systems. Doing so requires research, data standards, and incentives, and Dr. Lau outlined the contributions in each area: two ASPE-sponsored pilot studies with encouraging findings; an HL7 implementation guide for the National Health Care Surveys; and the opportunity to leverage CMS’s Medicare and Medicaid Electronic Health Record Incentive Programs and the 2015 edition of Health IT certification criteria. Eligible providers and hospitals can choose to submit data to the NHCS as one of the measures to meet the public health objective requirements under the incentive programs.

Since stating its readiness for public health reporting, CMS has been working to register eligible hospitals and providers, and to sample providers into the 2016 NAMCS and hospitals into the NHCS. The challenges anticipated relate to file size and storage, processing issues, and confidentiality for public use files. CMS is working with EHR vendors to test and improve the HL7 implementation guide, will start testing validation for NAMCS and is developing onboarding systems for registration. Finally, on behalf of Division Director Dr. Clarice Brown and himself, Dr. Lau acknowledged the many people at NCHS, ASPE, CDC, and ONC who have contributed to this project.

Discussion: NCVHS members praised the project and offered questions and comments on a number of topics including ways to cleanse the data received; a caveat about missing small, rural practices; use of new API concepts; privacy and security protections; and a potential role for health information exchange organizations.

  • 2015 National Content Test: Race and Ethnicity Research and Outreach ―Hyon Shin and Nicholas Jones, Bureau of the Census (slides)

Ms. Shin is Chief of the Racial Statistics Branch, and Mr. Jones is Director of Race and Ethnic Research and Outreach. They reported on two national content tests and research studies to determine certain race/ethnicity questions in the 2020 Census. One is an alternative questionnaire experiment on race and Hispanic origin; the other involves research on the “Middle Eastern or North African” (MENA) category. Mr. Jones said “the big driver is what the American public is looking for in terms of data that represents their communities,” using language and concepts that reflect how they see themselves.

The 2010 Census Race and Hispanic Origin Alternative Questionnaire Experiment (AQE) was prompted by the fact that a growing number of groups find these questions confusing, and people are increasingly responding “Some Other Race.” This could impact not only the Census but the federal statistical system. Also, there have been campaigns to change the questions. Mr. Jones reviewed the history of research on race and ethnicity terminology and data collection between the 1977 OMB race and ethnicity standards and the 2010 AQE. The latest AQE, the most comprehensive research effort ever undertaken in this area, is looking at alternative formats (separate vs. combined) for the question on race and Hispanic/Latino/Spanish origin. It has included a survey, re-interviews, usability testing, and focus groups across the country. The combined question was shown to be very successful, with a much lower non-response rate. The results, which identified good strategies for moving forward, will inform recommendations for the race/ethnicity content of the 2020 Census.

Like the other project, the National Content Test on the “Middle Eastern or North African” (MENA) category is looking at separate questions vs. a combined question (in two alternative formats, using write-ins or checkboxes) and at the instruction wording and terminology. The research is also looking at whether or not to include the category at all, and if so, how to operationalize it. Web-based designs are used in both projects to improve question understanding and optimize reporting of detailed racial and ethnic groups. The research and data analysis on the MENA category is continuing, with a 100-page study plan. This is the first time the Bureau is exploring how to collect data for Middle Eastern/North African populations. The goal is to improve the accuracy of data for respondents of Middle Eastern or North African descent.

The Bureau has completed the NCT and has done extensive outreach and engagement with myriad racial/ethnic communities, organizations, and leaders as well as with scholars and researchers. It held a national webinar on April 27. It will discuss its findings with OMB and the Interagency Working Group on Race and Ethnic Research in Summer 2016, and will present the NCT results and recommendations to the public, advisory groups, and stakeholder organizations in the Summer and Fall of 2016. The 2020 Census contents must be provided to Congress by April 2017 and finalized in 2018.

Discussion: NCVHS members had questions and comments on publication of the methodological studies; observations from the Massachusetts experience; the varieties of Americans’ self-identification and lived experience with respect to race and ethnicity; and the related impacts of age and language.

  • Electronic Public Health Case Reporting―Laura Conn, MPH, CDC (slides)

Ms. Conn (who spoke by phone) is Director of Health Information Strategy in CDC’s Center for Surveillance, Epidemiology, and Laboratory Services (CSELS). Electronic case reporting (eCR) is for legally-mandated reporting of reportable conditions by health care providers to state and local public health agencies. It will make possible more complete, accurate data; early detection and intervention; better detection of outbreaks; faster response to local and state needs; less burden on providers; and direct links between health care and population health. This will help advance all four pillars of CDC’s surveillance strategy. CDC’s priority focus is getting initial eCR while implementing a scalable architecture for eCRs that shows incremental success. The success depends on partnerships with EHR vendors and health IT communities, a standard data structure for initial eCRs, places and platforms for shared tools to facilitate eCR, secure and scalable standards and technologies, and support for state and local jurisdictions to receive the reports.

Ms. Conn showed a diagram of the information flow from the health care provider, with trigger codes generating an initial case report from the EHR to public health to adjudicate reportability, and on from there. She then explained the guiding principles for the triggers, noting that there will be one set of trigger codes for all conditions and all jurisdictions. The triggers are authored in a tool called VSAC, hosted at NLM. The electronic initial case report contains 40 items, determined by a CSTE task force. A standard structure, guiding principles, and an implementation guide have also been developed, and CSTE has begun work on a toolkit to assist public health agencies. CDC and CSTE are also building a knowledge base that standardizes reporting and a decision support tool that will be hosted on the public health community platform that uses the APHL’s AIMS infrastructure. For all of this to succeed, Ms. Conn stressed the importance of building a strong working relationship between public health and the health care and EHR developer communities, to counter a pervasive negative view of public health among clinicians. There has been considerable work with partners to that end. Other emphases include interoperability and incremental learning and improvement.

Work Group on HHS Data Access and Use―Vickie Mays, Ph.D., Josh Rosenthal, Ph.D., and Helga Rippen, Ph.D. (slides)

Dr. Mays gave an overview of the evolving thinking and planning for the Work Group. It is revisiting its work plan in an effort to suit its capacity to its charge and figure out the best space to work in. Its members (those who are not NCVHS members) are consultants who tend to engage around specific tasks and topics. There continue to be staffing challenges. The Work Group is developing a data matrix and guiding principles to help HHS agencies/data owners make their data more accessible and usable for four user groups: researchers, entrepreneurs, people running data warehouses, and community users with some level of data expertise.

Dr. Rosenthal presented some concepts and a working draft of a Data Access and Use Matrix. Its purpose is to allow different user types to make informed decisions about the usefulness of data and provide insight into the degree of difficulty in “consuming” those data. The categories of information on the data include publisher, description, currency/frequency, attributes, and usage/adoption. Questions could include how easily a data consumer can find data as well as the accuracy and meaningfulness of the data. He commented on the differences between “push” and “pull” models of data distribution, noting that the proposed matrix should be helpful for both; and he added that the matrix should be reviewed by a wide variety of users and groups to determine its value and develop it. Finally, he described several projects in which “secondary and tertiary delivery mechanisms” are repackaging HHS data for consumer use. The goal of this Work Group project is for data producers to have their data “go to the wind and be used by hundreds of thousands of people.”

Dr. Rippen asked for feedback and ideas on this project, to help the Work Group balance robustness and manageability. The Work Group hopes to have the matrix align with and augment the Data and Methods Framework that has been developed under the auspices of the Subcommittee on Population Health. Dr. Mays added that once the matrix has been fleshed out, it will be sent to members with a request for suggestions and comments as to its utility. The intent is to provide it to HHS and other data providers with a request that they will fill it out, with the possibility ultimately of recommending it to data providers as a best practice.

Discussing the proposed matrix, Dr. Cohen suggested adding use cases to illustrate possible uses of the matrix, and the group discussed ideas along these lines. Dr. Chanderraj suggested adding something on the validity of the data. Dr. Rosenthal said descriptive information about the data might include the intended use of the data. Ms. Love referenced her California HealthCare Foundation-funded project for county supervisors, which came up with criteria similar to those in the proposed matrix.

Finally, Dr. Mays called attention to a project of the Robert Wood Johnson Foundation, “Data for Health,” co-chaired by NCVHS member Dr. Dave Ross, which aligns and overlaps with NCVHS work.

Public Comment

After reiterating that people had submitted comments by email proposing changes in the letters reviewed earlier in this meeting, Dr. Suarez invited public comment.

Gwen Lohse of CAQH CORE spoke in support of comments sent by the CORE Chair and Vice Chair. Having been asked to propose specific language, she provided it to Ms. Goss for consideration in developing the final version of the letter. Dr. Suarez said the drafters would look at the new requests from CAQH CORE, and Ms. Goss asked all Subcommittee on Standards members to review them and provide input to the drafters. Dr. Suarez said written comments were also received from Mayo Clinic, the X12 chair, and NCPDP; Ms. Goss added that most were technical, and helpful.

A message was read from Durwin Day, commending the Committee on “an outstanding job of addressing the attachment recommendations.”


Updates from the Department: Privacy and Security

  • ONC Chief Privacy Officer Lucia Savage, JD (slides)

Ms. Savage began by reviewing the consumer right to access their health information and/or ask that it be sent to a third party, specified in HITECH and elaborated in OCR’s 2013 Omnibus Rule and again in the 2015 rule. This information access is very important for precision medicine. To educate consumers, ONC and OCR have made videos, an infographic, a blog, and other materials. The video has had about 10,000 unique users on the ONC website.

ONC and OCR also have been talking about sharing data for behavioral health, including talking to behavioral health practitioners. She noted that the constraints on data sharing in this area come not from HIPAA but from other sources such as Veterans rules and state law. ONC is working to help stakeholders understand when a legal consent form is required. It has funded the National Governors’ Association to develop a state interoperability roadmap. The fourth phase is a competitive process in which states can apply for technical assistance to implement some of their ideas.

Turning to the Application Programing Interface (API) Taskforce, she said it is charged with identifying perceived and real barriers to the use of APIs, developing recommendations for ONC for addressing “real” privacy and security problems, and helping consumers feel more comfortable using the technology. The taskforce, which specified a long list of “out of scope” issues, convened in early November and submitted its recommendations in mid-May.

Security topics include identity proofing, the Cyber Information Sharing Act of 2015, and ethical hacking. ONC is still working on a release on identity-proofing. The Cyber Information Sharing Act of 2015 has several requirements for health and human services, and ONC is working on some of them. A taskforce of industry stakeholders is working to identify best practices for improving cyberthreat sharing in health care. Another taskforce is about technology and software engineering standards in health care. Finally, Ms. Savage said ONC has been thinking about “ethical hacking,” spurred by Secretary Ash Carter’s invitation to “ethical hackers” to hack the Pentagon and identify vulnerabilities in the system. The question is how ONC can facilitate a similar practice without compromising privacy and confidentiality.

  • OCR: Rachel Seeger, ASPE

OCR has promulgated its final rulemaking on section 1557, the non-discrimination provision of the ACA―”a historic final rule that advances health equity and reduces health care disparities.” The rule covers discrimination on a wide range of bases.

There have been a number of HIPAA enforcement actions since February, several of which Ms. Seeger described. On the policy front, in addition to the new guidance on patients’ rights to access their health information, OCR issued guidance in the form of FAQs to elaborate on this subject, including on the suggested cost of copies. OCR helped produce the educational videos mentioned by Ms. Savage; and it has begun its next phase of audits of covered entities and their business associates, some of them onsite. OCR will identify best practices gleaned through the audit process and provide guidance targeted to identify compliance challenges. It also has undertaken a series of monthly newsletters on its listserv about cybersecurity.

Discussion: NCVHS members had questions and comments on unencrypted transmission; guidance on the format of information provided to individuals; possible ONC and OCR actions in response to the API recommendations; the merits of working with FTC, NIST and others to align standards; and concerns about unintended ways in which APIs could put patients at risk.

Subcommittee on Privacy, Confidentiality and Security Update―Ms. Kloss (slides)

Ms. Kloss gave an overview of the NCVHS hearing on de-identification in HIPAA, held in May. She and Ms. Bernstein thanked Ms. Seeger, then acting as lead staff, for her significant role in planning the hearing. The objectives were to increase awareness of current and anticipated practices, understand HIPAA’s de-identification requirement in that light, and identify areas for action. One overarching theme was that there is a “privacy-data collision” but little agreement about processes for de-identification and managing de-identified data. Also, good data science is available, but there are gaps in knowledge of these techniques, pointing to the need to improve education. The Subcommittee identified areas in need of further guidance or a change to regulation, and has developed a long list of takeaways. It plans to develop recommendations, and will soon decide what areas to probe more deeply.

Ms. Kloss then previewed the hearing scheduled for the next day on Minimum Necessary. Both it and de-identification are priority topics for the Office of Civil Rights. In consultation with OCR, the Subcommittee has decided first to develop a letter on minimum necessary, for action in September. At that meeting it will also present a preliminary outline of the thinking on de-identification, with a letter planned for presentation at the November meeting.

Subcommittee on Standards―Ms. Goss, Ms. Deutsch (slides)

This session focused on the plans for the Review Committee report, approval of the two letters discussed the previous day, the Subcommittee’s work plan, and a discussion of how to proceed with a roadmap for standards adoption. Ms. Deutsch reviewed the outline for the Review Committee report. It will be “highly technical,” with a more high-level executive summary. The report will be presented for action in September. Ms. Goss commended Ms. Deutsch for her work on this complex document and set of topics.

Ms. Deutsch then summarized the edits made to the draft letter on attachments following the previous day’s discussion. Dr. Suarez praised the letter as one of the most comprehensive and complete letters the Committee has written on the subject. With that, the Committee unanimously passed a motion to approve the letter on attachments, as revised.

Next, Ms. Goss presented the revised letter on proposed Phase IV Operating Rules. She said the Subcommittee had reviewed the feedback from CAQH CORE and ACS Xerox and reached consensus on changes to the draft letter, which she summarized. She recommended that in the future, a deadline for comments be stated when draft letters are posted prior to the NCVHS meeting at which action will be taken on the letter. After reviewing the changes, she moved that the revised letter be accepted, and the motion passed unanimously.

After outlining the Subcommittee’s “robust agenda” for the next four quarters, Ms. Goss said the Review Committee discussions had identified the need for predictability and a roadmap for the industry related to standards adoption. She asked for discussion to help the Subcommittee refine its work plan, noting the need to create predictability and efficiencies in standards development and adoption. Referencing a 2006 white paper on how to improve the standards process that she co-authored (updated in 2009), she noted the need for an in-depth conversation on this topic. The scope of the standards predictability roadmap and glide path includes standards development and maintenance, standards adoption, and health IT/EHR policy and payment advances. Concluding that “the industry is overloaded and needs things to settle down,” she solicited input from NCVHS colleagues. The Subcommittee’s short-term goal is to define a process for the next six months for roadmap development; the longer goal is to develop an orchestrated framework, roadmap/glide path for the next wave of adoption and implementation.


Members embraced the proposal to engage in this exercise. They agreed that scope would be a challenge, since the issues outlined by Ms. Goss intersect with many wider issues, several of which have arisen during this meeting. Those mentioned include the privacy/data collision, APIs, the future of vitals, surveys versus data mining, Public Health 3.0, new thinking about demographics, larger policy and reimbursement developments, and other data issues and themes including identifiers. Dr. Stead suggested getting clarity around the scope of the standards effort in such a way that the same method could then be reused to “step back and insert those other layers.” The product could provide valuable vision and practical guidance. Members expressed broad interest in using the standards-focused exercise to identify ways to align approaches to developments in population health and privacy as well as standards. Dr. Cohen noted that “standards” is a lens through which all NCVHS endeavors can be viewed, and he welcomed the opportunity to do strategic planning and promote alignment and convergence among NCVHS work streams. Ms. Kloss stressed the need for clarity about what is meant by “roadmap” before “digging into secondary processes.” Mr. Landen, noting the maturity of “this side of the industry,” noted the value of giving the industry greater predictability.

Ms. Goss observed that this discussion broadens the purview from standards to the full Committee. She and others agreed that the Subcommittee on Standards must be clear about the distinction between its scope―standards―and the wider context. She said the Subcommittee would start with a “standards thought process” but work to figure out how that leverages the entire NCVHS work plan and facilitates strategic planning. She noted that “the timing is good” for working on this over the rest of this calendar year. Dr. Mays commented on the possible implications for NCVHS structure and process; Dr. Suarez and others observed that the Committee already works and “pollinates” across Subcommittee boundaries to a great extent, facilitated by the Executive Subcommittee.

MACRA-Merit-Based Incentive Payment System―Pierre Yong, MD, CMS (slides)

The Merit-Based Incentive Payment System (MIPS) was established by the Medicare and CHIP Authorization Act (MACRA), along with Advanced Payment Models (APMs). Together they are called the Quality Payment Program. CMS has released its proposed rule on MIPS, the comment period for which closes on June 27. MACRA repeals a sustainable growth rate formula and streamlines three independent quality reporting programs (PQRS, VM, and Meaningful Use) into a single, new merit-based incentive payment program for clinicians. Meaningful use for hospitals continues. CMS sees this as a fresh start for these programs. The underlying idea is to “pay for what works.” Besides streamlining three programs, it adds the component of promoting ongoing clinical improvement and innovation.

Four domains make up the composite score: quality, resource use, clinical practice improvement activities, and advancing care information (i.e., leveraging health IT). In years 1 and 2, those eligible to participate are physicians, PAs, NPs, Clinical nurse specialists, and certified registered nurse anesthetists. In years 3 and beyond, eligibility expands to include physical or occupational therapists, speech/language pathologists, and many other types of clinicians. Clinicians not subject to MIPS include those in their first year of Medicare Part B participation, those below the low patient volume threshold, and certain participants in APMs.

Dr. Yong then explained the weighting assigned to the four performance domains, together creating a composite score; he also explained the scoring system. The ratios will change over time, with quality getting half the overall score in the first year. Clinicians can choose their six quality measures from a selection of about 300; and there are a few required measures. Eligible clinicians can participate in MIPS as individuals or a group (i.e., a group practice).

The first MIPS payment adjustments will go into effect in 2019, based on the performance year of calendar 2017. (2018 will be used for data collection and analysis.) CMS proposes “essentially a linear relationship” between the score and the payment adjustment. MIPS can adjust payments positively or negatively. In the first year, the adjustment will be between -4% and +4%; ultimately, it will be between -9% and +9%. In addition, bonuses of up to 10% are triggered for exceptional performance. There is a pool of about $500 million every year from 2019 to 2024 for exceptional performance; beyond that, the law requires MIPS to be budget-neutral.

Discussion: Members had questions and comments about the budget neutrality requirement; the timing of payments and penalties; the thinking behind the performance measures; the potential to create a new generation of quality measures that supports a pay-for-value model; the need for an advisory body in the quality space; the impact of the anticipated Medicare budget deficit; a possible role for NCVHS in this area; the burden on providers and possibility of leveraging states’ all-payer claims databases; the complexities caused by the existence of multiple payers with their own quality measures; and the risk of unintended consequences such as extreme complexity, the cost of participating, and clinicians cherry-picking patients to improve scores. Dr. Yong described the new Core Clinical Quality Measure collaborative between CMS and AHIP, which has identified a set of “core measures.”

Subcommittee on Population Health―Dr. Stead, Dr. Cohen, Ms. Brett

The Subcommittee and a smaller planning group have been active since the February meeting, refining the Community Health and Well-being Measurement Framework and planning how to vet it this summer as well as drafting an agenda for the Fall Workshop. Dr. Stead read a statement by member Dr. Dave Ross, describing his experience introducing and vetting the framework with government leaders in DeKalb County, GA. These leaders lack the broad and granular data on local health and social determinants they need to improve and protect residents’ health. They were enthusiastic about using the evolving NCVHS framework that will specify the areas in which data should be available to inform a county-wide action and health advocacy agenda. The Subcommittee hopes that DeKalb County could serve as a pilot site for the framework when it is ready.

The framework is a planning tool targeting three audiences: data collectors, communities, and data intermediaries and foundations. The Subcommittee’s goal is to develop consensus about a structure for essential community-level data in the framework and, based on discussions at the September 27 workshop, to develop recommendations to the Secretary on the federal role in this area. The current version of the framework (V2), with its nine domains and 23 subdomains, was informed by an extensive environmental scan conducted by Dr. Gib Parrish (now posted on the NCVHS website) and by ongoing feedback from NCVHS members and other colleagues. An effort has been made to ensure that every cabinet agency can “see themselves” in the framework. It is not “a prescriptive set of indicators”; rather, communities will populate the metrics with sub-county-level indicators relevant for their needs. The Subcommittee plans to vet the current version this summer and bring version 3 to the September workshop. Dr. Cohen said the Subcommittee wants feedback from a broad-based audience, and he asked members to share the framework with colleagues. Ultimately, it is envisioned as a tool that catalyzes both public/governmental and private efforts for the purpose of increasing access to community-level metrics and data.

Discussion: Members expressed appreciation for the DeKalb County use case. Some offered suggestions for additional content or modifications to the structure. Regarding the trajectory of the project, Dr. Stead explained that if consensus is reached about a workable framework of domains and sub-domains, the Subcommittee hopes to hand off the project to a public-private coalition or other collaborative effort to continue the work (curating a menu of measures, developing and/or cataloging tools that support sub-county measurement, identifying gaps, implementing pilots, and capturing success and learning). The Subcommittee is striving to include a breadth of participants from all relevant sectors in the Fall workshop to build momentum for the envisioned collaborative effort. RWJF was suggested as an appropriate curator.

Dr. Brett commented that the Subcommittee has learned that there are many, many players in this field; a role for NCVHS is to get them in the same room and build a coalition that includes but extends well beyond health. Ms. Hines added that part of the problem is that there is no explicit home in HHS for local data. NCVHS sees its role as “catalyzing the federal folks to step up and meet the private sector folks.” Dr. Mays, noting that HHS has many data sources besides those at NCHS, suggested working with the Secretary to figure out how to make the data available for use.

In summary, Dr. Cohen said the outputs after the workshop will be a consensus framework, recommendations to the Secretary, a workshop report, and strategies to engage and hand off the work to foster a coalition of other organizations. Dr. Stead added that the workshop report and recommendations will be presented for approval at the February meeting. The Subcommittee also plans to work with the Standards Subcommittee on a hearing on public health data standards and vitals and to continue working on the health data framework. The Co-chairs concluded by expressing great appreciation for the contributions of Dr. Kate Brett, the Subcommittee’s new lead staff.

Final Announcements―Dr. Suarez

Dr. Suarez made these announcements:

  • Mr. Soonthornsima has stepped down as Co-chair of Subcommittee on Standards because of the demands of his job; he will continue on the Subcommittee. Ms. Goss and the other members expressed their gratitude for Mr. Soonthornsima’s leadership. The new Co-Chair with Ms. Goss is Mr. Coussoule.
  • Dr. Evans has agreed to serve as co-chair of the Subcommittee on Privacy, Confidentiality and Security with Ms. Kloss.
  • Sally Milam’s tenure as an NCVHS member ended on May 31st. Dr. Suarez expressed thanks for her many forms of leadership during her service on the Committee and for her strong commitment to privacy and to consumers.

Ms. Jackson introduced and welcomed Geneva Cashaw as the newest member of the NCVHS staff team. Dr. Suarez acknowledged the many critical contributions of all NCVHS staff members. With that, he adjourned the meeting.

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



September 19, 2016