Department of Health and Human Services
NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS
February 17-18, 2016
Hubert H. Humphrey Building, Washington, DC
The National Committee on Vital and Health Statistics was convened on February 17-18, 2016, at the Hubert H. Humphrey Building in Washington, DC. The meeting was open to the public. Present:
- Walter Suarez, M.D., Chair
- Bruce Cohen, Ph.D.
- Nicholas Coussoule
- Llewellyn Cornelius, Ph.D. (by phone)
- Barbara Evans, Ph.D., JD (by phone)
- Alexandra Goss
- Richard Landen, MPH, MBA
- Denise Love
- Vickie Mays, Ph.D., MSPH
- Sallie Milam, J.D., CIPP/G (by phone)
- Michael O’Grady, Ph.D.
- Helga Rippen, M.D., Ph.D.
- Ob Soonthornsima (by phone)
- William W. Stead, M.D.
- Raj Chanderraj, M.D., FACC
- Linda Kloss, M.A.
- Bob Phillips, M.D.
- David Ross, Sc.D.
Lead Staff and Liaisons
- Rebecca Hines, NCHS, Executive Secretary
- James Scanlon, ASPE, Exec. Staff Director
- Terri Deutsch, CMS
Others (not including presenters)
- Debbie Jackson, NCHS
- Katherine Jones, NCHS
- Marietta Squire, NCHS
- Steve Lazarus, Boundary Information Group
- Gwendolyn Lohse, CAQH-CORE
- Pat Waller, Cambia Health Solutions
- Gail Kocher, BCBS
- Susan Kanaan, consultant
- Kate Brett, NCHS
- Michael DeCarlo, BCBSA
- Gail Kocher, BCBSA
- Paula Soper, ASTHO
- Christopher Eisenberg, CMS
- Terri Deutsch, CMS
- Laura Darst, Mayo Clinic
- Jean Narcisi, ADA
- Charles Stellar, WEDI
- Ruth-Ann Phelps, VA
- Robin Pondloy, NCHS
- Jeanette Thornton, AHIP
- Katie Knapp, VA
- Joan Turek, ASPE
- Karen Sorace, ASPE
- ACA Review Committee Letter: NCVHS members unanimously passed a motion to approve the revised letter on the Review Committee findings from the June 16 and 17, 2015, NCVHS hearing on adopted standards, code sets, identifiers, and operating rules.
- Population Health Subcommittee Workshop Summary: Members unanimously passed a motion to approve the summary of the Subcommittee on Population Health November 2015 workshop on Advancing Community-Level Core Measurement.
Welcome and Introductions
Dr. Suarez noted that two action items were being considered for action by the Committee at this meeting: the ACA Review Committee’s letter of recommendations from its June 2015 hearing, and a summary report on the November 2015 Population Health workshop on community-level core measurement.
Updates from the Department
- Elizabeth Holland and Shana Olshan, CMS
Ms. Holland, speaking by phone, briefed the Committee on the Medicare and Medicaid EHR incentive program, attestations, and Meaningful Use. The definition of Meaningful Use has been finalized for 2015-17, including for Stage 3. 2016 will be the last year for which Medicare will pay incentives; Medicaid incentive payments will continue through 2021. CMS and ONC recently stated the guiding principles for looking at Meaningful Use; the MIPS proposed rule will come out later this year. In response to a question, Ms. Holland said CMS is happy with the Meaningful Use submissions, which average 7,000 providers a day. Looking ahead, CMS wants to continue the progress on Meaningful Use that has been made to date.
Ms. Olshan first talked about the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015, which establishes a new framework for rewarding clinicians for value and puts them on the path toward it. She explained MACRA and the related MIPS program, which combines parts of the Physician Quality Reporting System, the Value-based Payment Modifier, and the Medicare EHR incentive program into a single incentives program, with payments starting in 2019. CMS has received comments and will implement the MACRA provisions through future notice and rulemaking. It is also working, pursuant to MACRA Section 501, to remove SSNs from Medicare cards and change over to a randomly-generated beneficiary identifier.
She noted that Acting Administrator Andy Slavitt described ICD-10 implementation as “the biggest event that no one heard about” because of the smooth transition, thanks to the strong partnership between federal government and industry. The strong educational resources offered by CMS have gotten some of the credit for the easy transition. Now, CMS is looking to transform the approach to evaluation, adoption, and implementation of administration simplification standards and operating rules, and the National Standards Group has an ambitious agenda. Ms. Olshan expressed interest in the impending recommendations from NCVHS on standards and operating rules. She outlined the evaluation framework CMS is developing, on which it will request public comment. CMS will move ahead with other aspects of administration simplification; she noted several facets of this work including certification of compliance, HPID, claims attachments, and a forthcoming request for feedback from NCVHS and ONC on opportunities to improve standardization and uniformity in new financial and administrative activities. Finally, she described her group’s “comprehensive compliance strategy” and the agency’s emphasis on education and outreach.
Discussion: Several Committee members asked that CMS create a graphic showing implementation timetables for all the initiatives described by Ms. Olshan, with a roadmap showing all the standards pieces that need to come together. These tools would make it possible to assess the cumulative implementation burden on the industry and the data capabilities expected over the next 2-3 years. Other members urged that the agency make sure it has rigorous baseline data against which to assess reforms; expressed interest in the emerging evaluation criteria; and proposed efforts to create predictability in the maintenance cycle. Members predicted “ripple effects through the health data community” as a result of the transition to a random ID for Medicare. Related to this, Dr. Suarez reported that NCVHS has received a letter from CHIME (Executives in Health Information Management), asking it to consider a role in facilitating industry discussion regarding patient matching systems. Jim Scanlon indicated he would explore whether this would be permissible given the language in the legislative rider prohibiting HHS from implementing any type patient identification systems.
- ASPE―Jim Scanlon
Mr. Scanlon began by welcoming new and continuing members to NCVHS and thanking them for their service. The Secretary signed the NCVHS charter in January, extending it for two more years. He then reported on HHS budget, policy and programmatic initiatives, data and statistical policy, and research projects. The FY2016 budget is in place, and hearings have begun on the 2017 budget. Taken together, the budget and the HHS strategic plan for 2014-18 (posted on the HHS website) are “the best guides to what HHS does and how it all fits together.” HHS also has plans for individual initiatives, including ones on precision medicine, the misuse of opioids, and delivery system reform. HHS is also coordinating the federal response to the water and environmental problems in Flint, MI, an effort that he called “a marathon, not a sprint” that would continue for a long time.
Mr. Scanlon then briefed the group on the work to monitor the impact of the ACA and health system reform using enrollment data, surveys, special research studies, and modeling. More is available thanks to efforts to improve the timeliness of data release from the National Health Interview Survey. Also regarding statistical policy, he described the Data Council’s work on aligning data collection from sources including administrative data, EHRs, surveys, and surveillance data. It has provided guidance to agencies regarding standard demographic data collection. One focus is access to care, particularly for vulnerable populations. The Data Council also was asked to look at data on health insurance, behavioral health, LGBT populations, and tobacco, and is doing so through the HHS portfolio of surveys, and will provide recommendations for moving forward. Particular progress has been made on health insurance measurement. Other focuses include American Indian tribes, on whom survey data are inadequate, and justice-involved populations.
Discussion: Dr. Stead called attention to possible changes in the ways in which some Americans value insurance and think about health care, and he wondered if any such trends are showing up in the data. Other members had questions and comments about race and ethnicity data, the life-course perspective, and the possibility of an NCVHS hearing on standards for data collection in situations such as the creation of a cohort for Flint.
Jon White, MD, ONC (by phone) (slides)
Dr. White talked briefly about ONC’s near-term health IT strategy, the Interoperability Roadmap, interoperability commitments, work with SDOs, FY2017 budget requests, and requests for new authorities. ONC is guided by the HHS value-based payment goals for improving how providers are paid, care is delivered, and information is distributed, with a particular focus on the last of these. Its three near-term strategies include ensuring the accessibility and usability of information, improving technology through a better market, reducing the regulatory burden, and aligning measures. These include an effort to simplify the overall reporting burden.
He noted that the Interoperability Roadmap may help meet the needs NCVHS members noted earlier regarding a roadmap. While ONC is responsible for the certification of health IT regulation, its “commitments and calls to action” also are designed to maximize program alignment among private and governmental colleagues. He cited the Precision Medicine Initiative, in which ONC has been heavily involved, as an example of its partnership efforts. It has reached out to private sector colleagues around three calls to action, aimed at easy consumer access to and sharing of their health information; refraining from blocking electronic health information; and implementing federally recognized, national interoperability standards.
ONC is working with SDOs to better align the standards development process, improve the testing of newly developed standards, and make the process more straightforward and consistent. One such effort involves creating feedback loops by which SDOs can get information from implementers about challenges they are experiencing with the standards or specifications.
The President is requesting additional funding for ONC in the 2017 budget in order to increase interoperability and further care transformation. There are also four requests for new authorities: to establish Health IT governance certification, prohibit information blocking and associated business practices, require health IT transparency, and continue to develop a Health IT Safety Collaborative.
Discussion: NCVHS members had questions and comments on the ONC safety initiative, the CHIME initiative, patient matching, and the importance of a broad consensus and state involvement.
ACA Review Committee: Letter of Recommendations from June 2015 Hearing―Ms. Goss, Mr. Soonthornsima, Ms. Deutsch (slides)
The ACA Review Committee co-chairs and lead staff presented the draft letter and recommendations from the June 2015 hearing (distributed previously to NCVHS members), starting with background comments. The focus of the review, as mandated by the ACA, is the extent to which existing standards and operating rules meet industry business needs. The Committee received written and oral testimony from 77 testifiers on a long list of topics. The letter will be followed in a few months by a more extensive NCVHS report on the subject.
After providing an overview of the draft letter, Ms. Deutsch took the Committee through it section by section, pausing for comments and questions, with a focus on the draft recommendations. Some modifications were suggested, especially to enhance the overall impact and effectiveness of the letter. A revised version of the letter based on this discussion will be presented for approval on day two of this meeting.
Dr. Suarez thanked Review Committee members, co-chairs, and staff for their long and hard work on the hearing, recommendations, and letter.
ICD-11―Donna Pickett, Chief, Classifications and Public Health Data Standards, NCHS (slides)
Ms. Pickett welcomed the opportunity to talk with the Committee about the next iteration of ICD, following the implementation of ICD-10-CM. After thanking NCVHS for supporting the transition, she focused her remarks on WHO’s work to create ICD-11 and the tools available on its website. (See the transcript and slides for the details of this presentation.)
She said ICD-11 is “due” in 2018. The revision goals are for the classification to work in an electronic environment, unlike its predecessors; to be a multi-purpose and coherent classification (covering mortality and morbidity); and to provide an international, multilingual reference standard for scientific comparability. To develop ICD-11, WHO formed topic advisory groups (TAGs) to focus on specific chapters (e.g., mental health, pediatrics). Ms. Pickett noted that WHO approved ICD-10 in 1989, and a lot has happened in medicine and health care since then, only some of which has been accommodated by annual updates. The structure of ICD-11 involves “linearization” (which she explained) across mortality, morbidity, primary care, and quality/patient safety.
She showed a diagram of the organization for the ICD-11 revision work, which is supported by the collaborating centers and regional offices as well as subject matter experts and working groups. The U.S. is involved as a member of the Revision Steering Group, part of the executive group, and in the overall task force, and Americans chair some of the TAGs.
After discussing definitions, Ms. Pickett reviewed the major events and activities involved in the revision, noting the amount of work going into modifying the content. She explained the concept of shore-lining, involving the cutoff between “very exquisite detail and what’s absolutely necessary for morbidity and mortality work.” After showing examples of hierarchy and coding and the names of the 26 chapters, five of which are new since ICD-10, she reviewed some of the differences between ICD-11 and ICD-10 related to coding scheme, terminology, numbering, extensions, definitions, and more. Finally, she showed a number of tools available on the WHO website, including a modification proposal tool. Some are downloadable. Also, there is a lot of online information. Beta testing will take place through WHO, and there will be field trials.
Regarding the relationship between the development of ICD-11 and ICD-10-CM, Ms. Pickett noted that the U.S. has its own updating process, and it will try to keep pace with what WHO is doing; but it is “all supposed to work together.”
Discussion: NCVHS members had comments and questions on whether ICD-11 will replace clinical modifications, expected business impacts, the mental/behavioral health chapter and data quality, and SNOMED. Ms. Pickett pointed out that ICD-10-CM has been in a partial code freeze for four years, impacting compatibility with DSM-V and other issues. Another question concerned how U.S. parties might improve their adoption processes.
All-Payer Claims Data Base Overview, Challenges, and Opportunities―Denise Love, Executive Director, NAHDO and NCVHS member
Ms. Love likened the development of All-Payer Claims Data Bases (APCDs) to the development of hospital discharge databases decades ago, in each case responding to the lack of standardization across states. APCDs are databases, created by state mandate, that typically include data derived from medical, pharmacy, and dental claims with eligibility and provider files from private and public payers including commercial insurance carriers (medical, dental, TPAs, PBMs) and public payers (Medicaid, Medicare). Typically, the APCDs start by bringing in claims from commercial payers; then the state normalizes them; and the process moves on from there.
The APCD Council is a learning collaborative of government, private, non-profit, and academic organizations focused on improving the development and deployment of state-based APCDs. It is convened and coordinated by the Institute for Health Policy and Practice at the University of New Hampshire and the National Association of Health Data Organizations (NAHDO). The process began in 2003 in Northeast states. The Council provides technical assistance to states and supports the learning network. Ms. Love said it has not yet “cracked the nut” of Tricare, VA, Indian Health Service (IHS), or federal employees’ health benefits plans.
She showed a U.S. map outlining the status of APCDs as of September 2015, with some 13 states having APCDs, nine having no activity, and the rest at some stage in the process. She described a foundational, circular development cycle that begins with stakeholder engagement and moves cyclically through governance, funding, technical build, and analysis and application development. The technical build goes quickly once the prior pieces are in place. The analysis and application development stage produces exciting and useful results that inform the stakeholders (employers, state agencies, consumers, purchasers, et al.), who bring different interests to the endeavor. After describing the different approaches to governance―state-led, public-private, and private non-profit―she showed several use case examples of applications and products from around a dozen states. (See slides and transcript for examples.)
Over all, Ms. Love said, “this provides a view of the health care system and how it’s operating and where the opportunities are to improve.” And states are starting to realize a return on their investment. The lessons learned include the importance of a multi-stakeholder approach and of forming relationships early on and throughout the process, as well as the importance of transparency, documentation, managing expectations, and identifiers. Seizing integration and linkage opportunities will be critical to the success of APCDs.
Discussion: In response to member queries, Ms. Love commented on the impending Supreme Court decision on ERISA plans, on which NAHDO worked with top lawyers to build a petition to the court. She then described a possible NCVHS workshop or hearing on APCDs, the purpose of which might be to stimulate discussion around what a core dataset might look like. Dr. Suarez noted that NCVHS had received a letter from AHIP asking it to facilitate standardization in this area. Other member questions and comments concerned sustainability, governance, data quality, the need for clinical as well as claims data, the anticipated impact of changing payment models, and the business case for CMS and the Department with respect to APCDs. Ms. Love and her fellow members explored ideas for an NCVHS hearing or workshop on the subject.
Update on Proposed Changes to the Rules Governing the Confidentiality of Substance Use Disorder Records―Kate Tipping, JD, HHS/SAMHSA (slides)
Ms. Tipping provided background on the current Substance Abuse Confidentiality Regulations (42 CFR Part 2) and an overview of the changes proposed in a February 9 Notice of Proposed Rulemaking (NPRM), published in the Federal Register. The purpose of the regulations is to ensure that patients receiving treatment for a substance use disorder in a Part 2 program are not made more vulnerable than those who do not seek treatment. They apply to all federally-assisted programs, and require patient consent before sharing patient information from a covered program, with limited exceptions.
The reasons that SAMHSA wants to revise the current regulations is that they were first promulgated in 1975, with updates in 1987, and health care delivery has changed considerably since then. There are also concerns about barriers to research; and a breach of privacy of information protected by Part 2 can still lead to civil and criminal consequences for patients. Finally, SAMHSA wants to modernize the regulations and make them more understandable. SAMHSA held a public listening session in June 2011 to solicit feedback on the current Part 2 rules, with 1,800 participants; and it received 112 oral and 635 written comments to a May 2014 announcement in the Federal Register. It collaborated with federal partner experts in developing the NPRM, to which comments are due on April 11, 2016.
Overall, the revisions facilitate the electronic exchange of substance use disorder information for treatment and other legitimate purposes while protecting confidentiality. Ms. Tipping outlined the major provisions proposed regarding applicability, consent requirements, confidentiality restrictions and safeguards, research, and audit and evaluation.
Discussion: Members had comments and questions about the impacts on care coordination and research.
Subcommittee on Population Health
- Overview of Recent Work―Drs. Stead and Cohen (slides)
Dr. Stead and other members welcomed Kate Brett, of the NCHS Office of Analysis and Epidemiology, as the new lead staff for the Subcommittee. He noted that the Subcommittee’s summary report on the November 2015 Workshop on Advancing Community-level Core Measurement would be submitted for Committee approval on day two of this meeting. To provide context, he then reviewed a Roadmap to Community-Level Health Measurement developed by the Subcommittee, which outlines a process for 1) developing a set of core measurement domains, 2) identifying methods to collect or estimate at the community level, 3) creating tools to support community-level measurement, and 4) capturing successes and learnings. NCVHS, under the Subcommittee’s leadership, is taking the lead on the first two of these steps, with the idea that the resources it develops in consultation with other stakeholders would then be ready for curation by one or more other public and/or private entities. The goal of the project is to enable communities to mobilize multisector action at the local level to improve population health and well-being.
This body of work builds on previous work on core community-level measurement domains drafted by Dr. Denise Koo for the Office of the Assistant Secretary for Health. (See November full Committee minutes and Workshop summary for further detail.) The November NCVHS workshop achieved its purpose of assessing the degree of consensus on core domains and stimulating engagement and contributions by a cross-section of stakeholders from federal agencies, states, communities, and non-governmental organizations. Dr. Cohen explained that a key finding was that the Committee needed more information to proceed with this effort, and as a result, NCVHS engaged Gib Parrish, M.D., to conduct a thorough environmental scan.
Dr. Parrish then briefed the Committee on the status this project. His written report on the scan is slated for completion by mid-March.
Environmental Scan of Non-Health Sector Domains―Gib Parrish, MD (slides)
The environmental scan had two major purposes: 1) to identify existing measurement frameworks or domains, indicators, and indicator datasets, primarily in the non-health sector; and 2) to identify data sources that support sub-county-level measurement. Dr. Parrish’s method was as follows: He located and reviewed Workshop participants’ suggestions for the aforementioned items; reviewed associated and newly-found indices and rankings; located and reviewed poverty and deprivation indices and indicators; located and reviewed the same factors for specific sectors; grouped identified indices, rankings, and indicator systems by type (in six categories); categorized domains using a subset of frequently-used domains; and compiled sources of sub-county data identified during the scan. He showed the Committee his preliminary findings for each of these steps.
He then offered a number of observations derived from this analysis. First, the development of the systems or indices, and thus their purpose and function, varied considerably and included efforts by grassroots and community groups, academic institutions and expert panels, and national or international organizations. There was also variation in the degree of expertise of the participants. He highlighted “pivotal work” by the National Neighborhood Indicators Partnership, part of the Urban Institute, and the work of the Community Indicators Consortium. In addition, a recent collaboration between the federal agencies EPA, HUD, and DOT on livability principles may produce useful results and represent an opportunity for HHS collaboration. He noted a number of terminology issues as well as the range of conceptual levels of domains and categorization of indicators by domains. Some systems use metrics or indicators to generate an overall ranking or index, while others instead are used to assess community health and well-being in order to prioritize local resources in areas most needed.
Dr. Parrish shared a list of thirteen sources of sub-county-level data and showed the ten categories of indicators in the 2015 American Community Survey. Finally, he outlined the remaining steps for the environmental scan, the last of which is to develop a revised set of domains with examples of indicators/metrics and data sources for each domain.
Discussion: The presentation prompted a rich discussion. One member wondered about the Committee’s space in the national/international endeavor around community-level indicators, and called attention to the concerns about the relevance of such efforts among communities of color. She cited the different possible frames of reference, including social determinants of health, life course (e.g., taking into account ACES), and equity, and the challenge of capturing diversity and variability; and she pointed to social inclusion as an illustrative data point. Dr. Stead affirmed that this NCVHS project aims to develop measurement approaches and tools that will work with any and all of these perspectives in assessing the well-being of a community and all its residents. The report, he said, will include a scenario that shows “how these domains look, feel, and are actionable from equity, determinant, and life course perspectives.” He added that another goal of the project is to show how the domains work for other sectors and government agencies (e.g., Justice, Transportation) for their priorities.
Other members cautioned against “bundling things de facto”; suggested including mashup data; noted the opportunity to help policymakers see a complete picture; stressed the importance of creating a two-way conversation with data sources and users; noted the wide variation among communities; and cautioned against reinventing the wheel. Ms. Hines affirmed that there are “hundreds of these [indicator] efforts already out there”; the NCVHS focus is on the federal role, including where the gaps are and what tools government could provide to communities.
Work Plan: As part of the wrap-up, the co-chairs briefly described the Subcommittee’s work plan. It includes another workshop on this topic on September 27, leading to a final report and recommendations to the Secretary. It hopes to complete its work on this project and hand it off to appropriate partners once the recommendations are submitted to the Secretary.
Subcommittee on Standards: Hearing Plans, Work Plan―Ms. Goss, Mr. Soonthornsima, Ms. Deutsch (slides)
Ms. Goss stated that the objectives for this session are to review the Subcommittee’s work plan and discuss the previous day’s hearing “HIPAA and ACA Administrative Simplification: Phase IV Operating Rules and Attachment Standard.” To orient the Committee, Mr. Soonthornsima gave an overview of the operating rules topics addressed during the February 16 hearing and slated for further exploration by the Subcommittee. The operating rules include those for enrollment/disenrollment, premium payment, health care claims, and prior authorization. A panel at the hearing also discussed attachments. He used a slide from CAQH CORE to show the changes in these areas that would apply if CORE’s recommendations are enacted. Operating rules cover two key areas – infrastructure and connectivity. They do not focus on content. The salient points heard at the recent hearing included general agreement on the fact that acknowledgement is needed for all transactions, and general opposition to using X.509. Mr. Soonthornsima shared additional points from the hearing, as well, and said there was good discussion regarding attachments. Providers will have a learning curve to begin to use EHRs for extracting attachments. Significant findings from the Review Committee hearing will be addressed in its letter to the Secretary and/or its forthcoming report.
Dr. Suarez outlined an incremental process, noting that the Committee would both evaluate operating rules “in a packet” and “unlock the packet” and look at specific operating rules. Mr. Landen observed that interesting policy decisions are involved, with a lot of tradeoffs.
Turning to the Subcommittee’s 2016 work plan, Ms. Goss outlined the topics, products and activities tentatively planned for each quarter. The Committee discussed the optimal timing for these tasks, partly in view of bandwidth, and they identified topics that can be taken on by the full Committee. Dr. Cohen expressed interest in working on public health standards and vital statistics; Ms. Love said she is drafting ideas for a workshop on APCDs; and several other possible topics were put forward including one by Dr. Rippen regarding data models.
All Subcommittee work plans are being compiled into a comprehensive NCVHS work plan (see the final agenda item of this meeting).
Two persons spoke during the public comment period. First, with respect to the foregoing Subcommittee on Standards discussion, Gwendolyn Lohse, the Managing Director of CORE, pointed out that more than 100 entities voted for the Phase IV package, representing a large percent of the commercially insured, as did several federal agencies, state Medicaid programs, and others.
Second, Steve Lazarus, a former chair of WEDI and the HIPAA Summit co-chair, urged the Committee to “deliberate very thoughtfully” as it considers “the comments it has heard versus the testimony provided by the authoring entity for the operating rules.” He reviewed some relevant history and urged the Committee to “take a leadership role as it did with ICD-10.”
Updates from the Department: Privacy and Security
- Deven McGraw, OCR
Ms. McGraw, OCR’s Deputy Director for Health Information Privacy, reported on recent OCR enforcement activities and, on the policy side, the publication of a final rule. First, she described enforcement activities involving settlements with Lahey Hospital, Medical Center of MA, Triple-S Management Corporation of Puerto Rico, University of Washington Medicine, and Complete PT; and a summary judgment in the government’s favor against Lincare, a home health care entity. (The latter can be appealed.) This year, OCR will launch the second phase of its audit program, as directed by Congress in HITECH. Most will be desk audits, with some onsite audits.
On the policy front, OCR issued a final rule authorizing a small subset of covered entities that report to the National Instant Criminal Background Check System (NICS) to report persons who meet the definition of “a mental health prohibitor” and thus are not allowed to have any kind of gun. OCR also has issued guidance on the individual right to access health information under HIPAA, with a comprehensive fact sheet and FAQs regarding this right. Another set of FAQs is forthcoming on the issue of fees for access. OCR also has been working on the President’s Precision Medicine Initiative, and developed the privacy and trust principles to govern it. Companion security principles are being developed.
OCR has worked with ONC to develop two fact sheets on permitted uses and disclosures, and it created a developer portal to help developers determine under what conditions they are covered by HIPAA. Using the portal, developers can ask questions and have a dialogue. OCR also has uploaded HIPAA app use scenarios as examples.
Finally, Ms. McGraw said that cybersecurity is “front and center” for OCR, which enforces specific rules on security that have strong implications for cybersecurity. OCR is working with the Department on several initiatives in this area.
Discussion: Dr. Suarez asked about stronger coordination between OCR, FDA, FTC, and FCC, given that they are all involved with cellphone medical apps. Ms. McGraw said a tool is in the pipeline to show what legal regimes people need to look at based on a product’s functionality; and there is collaborative work on the enforcement side. Asked for the broad perspective on enforcement and compliance, she said, “We are still most definitely climbing up the hill.” Asked about the ratio and relative ROI of compliance reviews vs. addressing complaints, she said most complaints are resolved through technical assistance. To another question, she said that there are repeat offenders, and OCR is “developing a better strategy for handling” them. Other member questions concerned price transparency, what OCR advises about security protections (it directs people to the NIST standards), and APIs (which she referred to Ms. Savage).
- ONC Chief Privacy Officer Lucia Savage, JD
After noting that ONC and OCR have been working especially closely together lately, Ms. Savage said that ONC has recently taken actions to address the hypothesis that people do not understand the HIPAA privacy rules. In February, it released two fact sheets and a series of blogs, all on the same content. ONC and OCR worked together to elevate ideas and examples embedded in the final rule preambles into graphic illustrations that help “ordinary people” understand the privacy rules. The purpose, she said, is to “move people to yes” with respect to appropriate data release and interoperability.
In support of the interoperability roadmap, ONC is also working on additional products to make things easier to understand. She commented on some of these resources, with examples of various scenarios in different contexts, and encouraged NCVHS members to provide feedback on the resources.
Regarding APIs, which automate data exchange in unprecedented ways, Ms. Savage said ONC hopes its fact sheets will help institutions that trade with each other to feel confident in using such technology. She added that an underlying assumption is that most people who manage their families’ health information are “competent adults” who “make decisions about comparable stuff in their lives every single day, and health care from a consumer perspective is no different.”
The joint API Taskforce is tasked with identifying privacy and security concerns that are unique to APIs and advising ONC on how to help consumers feel confident in using this technology. It met in January and heard from a range of organizations and advocates. She outlined some of the concerns related to consumer apps. In general, APIs are seen as more secure than less-precise systems. One question is whether providers and consumers understand how they work, and how ONC and OCR can facilitate this understanding; and there was a big discussion about consent. The task force will run through April and may report to the ONC FACAs in March. Its meetings are public.
Discussion: NCVHS members had questions and comments on the NSF program Smart and Connected Health; EHR developer concerns about API breaches; the increasing sophistication of hackers; and patient-generated health data.
Subcommittee on Privacy, Confidentiality and Security―Dr. Suarez (slides)
On behalf of Subcommittee co-chair Linda Kloss, Dr. Suarez welcomed Rachel Seeger, who has been detailed from OCR to ASPE, as Subcommittee lead staff for the next few months. He then reviewed the Subcommittee’s thinking about its 2016 areas of focus, timeline, and 2016-17 work plan. It plans to focus on Minimum Necessary guidance; de-identification and re-identification guidance; and a future view of health data privacy, confidentiality, and security, with hearings planned for each of these, followed in each case by a letter or report. The Subcommittee has created separate task forces on the first two topics. The hearing on De-identification and HIPAA is scheduled for May 24-25, 2016. The hearing on Minimum Necessary and HIPAA is scheduled for June 16.
Members discussed the complexity and significance of these topics. Dr. Suarez and Dr. Rippen commented on the challenges of dealing with the “dual world” of covered and uncovered entities with respect to HIPAA, especially given the proliferation of uncovered entities and many changes in technology. Mr. Scanlon reviewed the thinking around this matter when HIPAA was first passed in the 1990s, in a “largely batch-processing world.” The privacy and security principles have remained, even as technology and other factors have changed considerably. At the time, he recalled, “the concept of covering everyone or at least more covered entities was part of the original formulation.” NCVHS and the Secretary recommended to Congress that the privacy principles should cover everyone who held personally identifiable information. However, the legislative process ended in a default version of HIPAA that left in place a framework that is now “somewhat dated.”
- ACA Review Committee Letter
After Ms. Goss reviewed the modifications made to the draft letter based on the previous day’s discussion and other suggestions, NCVHS members unanimously passed a motion to approve the letter as revised.
- Population Health Subcommittee Workshop Summary
Members unanimously passed a motion to approve the workshop summary, with thanks to the Subcommittee and consultant writer Susan Kanaan.
Work Group on HHS Data Access and Use―Dr. Mays
Dr. Mays gave an overview of the evolving thinking about and planning for the Work Group on HHS Data Access and Use. She noted that its comprehensive charge has seven components, and “we are trying to match our capacity with our charge.” Unlike NCVHS, its members (i.e., those who are not themselves NCVHS members) are consultants who tend to engage around specific tasks and topics. There have been staffing challenges, and Dr. Mays hopes to get student interns to help with the workload. Besides advising HHS on enhancing the accessibility and usage/usability of its data, the Work Group is available to advise NCVHS on its work and dissemination of its products.
At present, a priority for the Work Group is to come up with a framework or approach for guidance to HHS agencies/data owners on making their data more accessible and usable. This begins with helping them understand their audiences, and moves on to helping them expand to additional audiences and/or forms of data access, such as data queries. The Work Group is moving toward developing some form of general advice, possibly a template or questionnaire. Over all, it thinks in terms of four use cases: for researchers, entrepreneurs, people running data warehouses, and community users with some level of data expertise.
Dr. Mays added that one concern is that once the Work Group issues advice, it does not have the power to help recipients (e.g., NCVHS subgroups) carry out the advice. She also noted that there is interest in a presentation to the HHS Data Leads group on the NCVHS Data and Methods Framework, following a planning meeting with Mr. Davis of the IDEA Lab. NCVHS members talked briefly about possible ways to move forward, and about the potential for greater use of infographics.
NCVHS Strategic Plan and 2016 Work Plan
The Committee concluded the meeting by revisiting the evolving planning document that provides a framework for coordinating Subcommittee, Work Group, and full Committee work plans. With attention to topics, products, and activities, members talked about what topics to address, when, and under whose auspices (i.e., the full Committee or a specific subcommittee). The Committee’s bandwidth was a major theme of the discussion, including staffing, time, and financial resources. Ms. Hines said the Committee would have reduced funding to work with in FY2017. The group sketched out plans for every quarter of 2016.
There were no public comments, and Dr. Suarez adjourned the meeting.
I hereby certify that, to the best of my knowledge, the foregoing summary of minutes is accurate and complete.