3.2: High-Value Data Sets and Tools

Inventory and release additional high-value datasets

Other Information:

New High-Value Data Sets and Tools - “High value” is defined by the Open Government Directive as information which can be used to increase agency accountability and responsiveness, improve public knowledge of the agency and its operations, further the core mission of the agency, create economic opportunity, or respond to need and demand as identified through public consultation. As described earlier, the Chief Information Officer Council and Data Council at HHS have executed an initial review of the current inventory of HHS data to see what additional high value data can be released. A directory of major HHS data and statistical systems is available at http://www.hhs-stat.net/scripts/meta_des_new_17.cfm and is continually updated, and an inventory of Office of Management and Budget-approved data collection projects is available at http://www.reginfo.gov/public/do/PRAMain. As a result of this initial portfolio review, HHS has decided to release 14 new high-value data sets and three new high-value tools on Data.gov by the end of 2010. Of the 14 new high-value data sets, 12 have never previously been available to the public in any form -- 10 data sets from the Centers for Medicare and Medicaid Services (CMS) alone. (The other two data sets are either online for the first time or downloadable in open format for the first time). The three tools – the CMS Dashboard, FDA-TRACK, and the Office of the National Coordinator for Health Information Technology’s Dashboard – will be brand new. In addition to these 17 new data sets and tools, HHS will be posting more than 40 existing data sets and tools to Data.gov by the end of 2010 – data and tools which are already available online in some form but will be updated with respect to their content and formally registered on Data.gov We present key highlights, below, with a particular focus on two divisions of HHS that are emerging as leaders of the next generation of transparency at HHS: the Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA). Centers for Medicare and Medicaid Services (CMS) We are delighted to announce that CMS is embarking upon a transparency program of unprecedented scope and energy – a development of great importance to HHS and to the transformation of health care. Information is the lifeblood of health care improvement work. Without information, it is impossible to truly understand the current state of health care costs and quality and determine how to improve it. CMS is uniquely positioned to provide such information – and thereby providing transparency both into its own operations and also into American health care itself. 1. The CMS Dashboard. Launched in “beta” mode on CMS’s website on April 6, the CMS Dashboard (http://www.cms.gov/Dashboard/) is one of HHS’s official “Open Government Flagship Initiatives” ○○ The Dashboard is an exciting new web application which allows the public to visualize and analyze Medicare spending with unprecedented ease and clarity – beginning with inpatient hospital spending ○○ The initial version of the Dashboard allows users to track and graph Medicare spending on inpatient hospital services by state, by the top 25 “diagnosis-related groups” (DRG), and by top 10 hospitals for each state and diagnosis-related group over time. Users can also see how much Medicare is spending to support important public policy goals, such as the provision of medical education, additional funding to hospitals that take a disproportionate share of low-income patients, additional payments to rural hospitals, additional funding to hospitals who take cases that incur extraordinarily high costs of treatment, and adjustments for the underlying costs in different geographic regions. ○○ While much of this data had previously been available in some form to the public, scattered across hard copy and electronic publications, analysis of the data required retrieval of it from disparate places and having your own computer programmer and in-house Medicare expert to pull it together – barriers which the Dashboard now eliminates ○○ Furthermore, the Dashboard makes Medicare inpatient hospital spending data available to the public in a much more timely way than ever before. Data for a given quarter is published less than three months after the end of that quarter, vs. a previous publication lag time of up to 18 months ○○ Finally, the beta version of the Dashboard is just the beginning. After moving the Dashboard to full production mode, we plan to evolve and grow the Dashboard on an ongoing basis, adding more and more data and functionality – beginning with the next major release of the Dashboard in the fall of 2010 ○○ The Dashboard will provide the public, researchers, policymakers, health care providers, and others with key information on the status of and emerging trends in Medicare service utilization and spending – insights which will help power bettertargeted, more timely work to improve our health care system 2. Creation of 9 Medicare claim “basic files,” including one for each major category of health care service, to be released from September to December 2010 for free public download on Data.gov. These files will contain a limited number of variables and be de-identified and configured through a rigorous process, in close consultation with privacy experts, re-identification experts, researchers, and key stakeholders, to ensure the protection of beneficiary privacy and confidentiality ○○ As a by-product of administering Medicare, CMS maintains a comprehensive database of claims for all traditional Medicare beneficiaries (about 80% of the Medicare population) – claims from different settings and types of care, including (1) inpatient hospital, (2) outpatient hospital, (3) skilled nursing facilities, (4) home health, (5) hospice, (6) carrier (physicians and suppliers), (7) durable medical equipment, and (8) prescription drugs ○○ To date, access to these claims has been very restricted ○○ CMS is initiating a project to improve access to its data by creating “basic files” from claims data for public use ○○ The primary product will be a set of “basic files” containing 2008 claims data for a randomly selected 5% sample of the Medicare population (about 2.4 million beneficiaries). There will be a separate file for each of the eight claim types noted above. CMS also plans to create an “enrollment file” describing the number and the demographics of the beneficiaries in the 5% sample to support the calculation of population-based rates and proportions ○○ The files will be carefully stripped of information and include only a limited number of variables– hence the term “basic files.” This work will be executed through a rigorous and intensive process, consulting closely with privacy experts, re-identification experts, researchers, and key stakeholders, to ensure that beneficiary confidentiality is entirely protected. As a key note, each of these 9 files will be “stand-alone” files, published without identifiers that link claims across files to a given beneficiary -- to ensure that a beneficiary cannot be re-identified through their pattern of claims. The de-identification protocol applied to these files will also be such that claims will not be able to be linked to individual providers ○○ We are planning to make these 9 files available to the public, downloadable at no charge, through Data.gov. The first of the claim “basic files” will be released in September 2010, and all 9 of them will be published by December 2010 ○○ This will represent the first time these kinds of data have been made available to the public ○○ These files will allow users to study health care services provided through the Medicare program in ways never possible before. The effort is intended to enhance Medicare program transparency and can provide a vital spark for new research and innovation, ultimately leading to improved outcomes for Medicare beneficiaries and the Medicare program 3. Significantly improved user interface and analytical tool for the public to use to access CMS’s existing COMPARE data on health care provider quality performance – launched with the rollout of this Open Government Plan at data.medicare.gov ○○ As mentioned previously, one of the most potent and useful data sets CMS has published on Data.gov is detailed quality performance data for individual hospitals, nursing homes, home health agencies, and dialysis providers across the country – a data set called “COMPARE” ○○ This data can help consumers make better care decisions. Providers are using COMPARE data as an important tool to help them guide their quality improvement efforts, with measurable and discernible results. The COMPARE data set helps researchers gain new insights into care delivery, and aids policymakers in their decision making ○○ While quite powerful, this data set has been difficult for users to utilize and manipulate in the past, hampering its impact ○○ At data.medicare.gov, as of the rollout of this Open Government Plan, CMS has now launched a new user interface which the public can use to not only view the data much more easily, but also to customize that view by providing sort, search, and filter capabilities. In addition, users will be able to socialize and share the data through social media networking sites such as Facebook, Twitter, etc. 4. Medicare Part B National Summary File – now downloadable at no charge ○○ This file provides a detailed breakdown of the volume of physician services delivered to Medicare beneficiaries and how much Medicare paid for those services – by type of physician procedure. It can be used to look at trends in types of services delivered over time or to better understand the magnitude of the health needs of the Medicare population ○○ This much-in-demand file was previously available for a fee of $100 per year and only on CD ROM ○○ On January 22, as part of the new high value data sets HHS delivered to the public as per the Open Government Directive, CMS made the 2008 Part B National Summary File available downloadable from Data.gov for free. Files from 2000-2007 are now also available for download from the CMS website for free 5. Medicaid State Plan Documents – to be put online on CMS’s website by the end of 2010 ○○ CMS has initiated a multi-stage project to place the detailed formal documents describing each state’s Medicaid Plan (each of which is unique) on the CMS website, much as the documents describing the Children’s Health Insurance Program State Plans are currently on the CMS website ○○ Through the Medicaid program, states and the federal government fund a wide range of health services for low income families, pregnant women, children, the elderly, and the disabled ○○ The Medicaid State Plans are the legally binding documents that serve as contracts between the federal and state government. Each State Plan outlines in detail the nature of that state’s particular Medicaid program, including benefits provided, populations covered and extensive details on the program’s structure, financing and management. They are each accompanied by a stream of amendments that modify the program on an ongoing basis ○○ Putting the State Plans and their associated amendments online will promote accountability and provide valuable information for citizens about what their government is doing ○○ The process of compiling all plans and amendments, ensuring that they are complete and accurate, validating them with the states, and putting them online on the CMS website in a standard format should be completed by the end of 2010. 6. New community-level indicators of health care cost, quality, and utilization, to be supplied by CMS to the new HHS Community Health Data Initiative by the end of 2010 ○○ As a key part of HHS’s new Community Health Data Initiative – another one of HHS’s “Open Government Flagship Initiatives” – CMS will be contributing an exciting new set of metrics that describe community-level Medicare prevalence of disease, quality, costs, and utilization of services across the country at a national, state, regional, and potentially county level ○○ These community indicator metrics, derived from Medicare data, will either be brand new to the world or at a finer level of precision than has previously been available to the public from other sources ○○ Combined with other HHS data on the health and health care performance of communities, this vital new CMS data can be used by a wide variety of stakeholders to gain new insights into local health and health care performance and to develop new tools, strategies, and programs to improve the value of health care and health performance in local regions ○○ For more on the Community Health Data Initiative, see the Flagship Initiatives section 5.5, page 58 Food and Drug Administration (FDA) Like CMS, FDA is engaged in an unprecedented push to become more transparent. Two of FDA’s initiatives are highlighted here as official HHS “Open Government Flagship Initiatives” -- the FDA Transparency Initiative and FDA-TRACK. 1. FDA Transparency Initiative FDA Commissioner Dr. Margaret Hamburg launched the agency’s Transparency Initiative in June 2009. Over the years, some stakeholders have complained about FDA’s lack of transparency. The agency has been referred to by some as a “black box” that makes important decisions without explaining them. The objective of the FDA Transparency Initiative is to render FDA much more transparent and open to the American public. Increasing FDA’s openness will help the agency more effectively implement its mission to promote and protect the public health by providing the public with useful, user-friendly information about agency activities and decision-making. Commissioner Hamburg formed an internal task force representing key leaders of FDA to oversee the initiative. Commissioner Hamburg asked Dr. Joshua Sharfstein, the Principal Deputy Commissioner of the FDA, to chair FDA’s internal task force, whose members include five of the Agency’s Center Directors, the Chief Counsel, the Associate Commissioner for Regulatory Affairs, and the Chief Scientist. The Task Force was charged with soliciting public input on ways the agency can improve transparency and making recommendations to Commissioner Hamburg for ways the agency can operate more transparently to benefit the public health. Over the last eight months, the Task Force has held two public meetings, launched an online blog (accessible at http://fdatransparencyblog.fda.gov/), opened a docket, and held listening sessions with representatives of regulated industry. At the first public meeting, the Task Force solicited comments on how the Agency could improve transparency overall. Thirty five individuals provided comments during the meeting and 335 people attended in person or watched the live webcast of the eight hour session. At the second public meeting, the Task Force solicited comments on three specific issues related to transparency at the agency: (1) early communication about emerging safety issues concerning FDA-regulated products, (2) disclosure of information about product applications that are abandoned (no work is being done or will be undertaken to have the application approved) or withdrawn by the applicant before approval, and (3) communication of agency decisions about pending product applications. Sixteen individuals participated in the groups convened to discuss each issue as well as during the open public session. One hundred seventy four people attended the meeting in person or watched the live webcast. The online blog and the docket have received over 1,380 comments. The blog has offered an opportunity for exchange about specific ideas for transparency at the agency. The Task Force is also collecting information on how to improve FDA’s transparency to regulated industry. It held three listening sessions with members of regulated industry in January 2010 and have made available the transcripts and summaries of those listening sessions (accessible at http://www.fda.gov/AboutFDA/WhatWeDo/FDATransparencyTaskForce/default.htm). The Task Force is proceeding with the Transparency Initiative in three phases: Phase 1: FDA Basics. The first phase is intended to provide the public with basic information about FDA and how the agency does its work. In early January 2010, FDA launched a web-based resource called FDA Basics (accessible at http://www.fda.gov/fdabasics). The launch involved a media call and webinar with bloggers on FDA issues. This resource now includes (1) 115 questions and answers about FDA and the products that the agency regulates, (2) eight short videos that explain various agency activities, and (3) conversations with nine agency officials about the work of their offices. The initial content for FDA Basics was based on questions and comments the agency frequently receives from the public. FDA will continue to add user-friendly information to the site. In addition, visitors to FDA Basics can rate the helpfulness of the information provided and suggest additional questions for inclusion in FDA Basics. The agency has received over 2,700 comments from the public since the launch of the FDA Basics resource. Feedback provided by the public is used to update the resource. Each month, senior officials from FDA product centers and offices host 30 minute online sessions about a specific topic and answer questions from the public about that topic. Each of these sessions is announced on the FDA web site, the online blog, and promoted to other stakeholders FDA employees identify. The FDA Basics webinar series was launched in February with a webinar on “Access to Investigational Drugs,” hosted by FDA’s Office of Special Health Issues. An audio replay and copy of the PowerPoint slides from the session are available on the FDA Basics web site. Early reaction to FDA Basics has been positive. One blogger wrote, “[t]he initiative can go a long way toward educating the public about what FDA does—and how—and also provide industry with real-time answers to their daily challenges, ultimately improving product quality and patient safety.” Another blogger wrote, “[i]t is really well put together, clear and works quite well. . . . The site is not only supportive of transparency, but is highly instructive and educational.” Phase 2: Public disclosure. The second phase of the FDA Transparency Initiative relates to FDA’s proactive disclosure of information the agency has in its possession, and how to make information about agency activities and decision-making more transparent, useful, and understandable to the public, while appropriately protecting confidential information. Phase 3: Transparency to regulated industry. The third phase will address ways that FDA can become more transparent to regulated industry, in order to foster a more effective and efficient regulatory process. FDA is now seeking public input through the Federal Register Notice process, and draft recommendations from this phase are expected in the spring of 2010. 2. FDA-TRACK In addition to the FDA Transparency Initiative, the other FDA project to be designated an official HHS “Open Government Flagship Initiative” is FDA-TRACK, the FDA’s new agency-wide program performance management system. When fully implemented, FDA-TRACK will monitor over 90 FDA program offices through key performance measures that will be gathered on a monthly basis. Each quarter, the FDA-TRACK team will analyze monthly performance data, with senior managers presenting these data to FDA senior leadership. Very importantly, the public will be able to track the agency’s progress through the FDA-TRACK website – which will debut in “beta” mode on April 7, with most of FDA’s offices represented. Consistent with the principles of open government, FDA-TRACK adheres to values that comprise its name – Transparency, Results, Accountability, Credibility and Knowledge-Sharing. 1. Transparency – The FDA-TRACK website (fda.gov/fdatrack) enables all interested external and internal visitors to view performance data at the program office level and gain a better understanding of the breadth of FDA’s core responsibilities, as well as see progress on important projects and programs. When fully implemented, the website will include data for over 300 performance measures and 80 key projects at the FDA. The website will be updated regularly so viewers can monitor the accomplishments and trends for each program area. Complementing the work of the Transparency Task Force, FDA-TRACK exemplifies FDA’s commitment to expanding public access to important information. 2. Results – FDA-TRACK highlights performance measures with relevance to the agency’s public health mission. These include the timeliness of reviews, the number of high risk inspections completed, and the completion of key research projects. Over time, FDA intends to include more measures that reflect public health outcomes across a broad range of agency activities. 3. Accountability – Developing, tracking and reporting performance measures will improve the agency’s accountability to the public. In addition, internal discussions between FDA’s senior leaders and program office senior management are conducted each quarter to promote sharing of ideas and hold each FDA office accountable for its priorities, plans and results. 4. Credibility – Sharing information about FDA performance is important for the agency’s credibility. The FDA-TRACK website will provide an unprecedented look into how FDA does its work. The site also allows visitors to submit comments on both the general features of the program as well as specific performance measures. Website hits and feedback will be monitored on a daily basis by the FDA-TRACK team, and suggestions will be considered as part of our continuous improvement efforts. A recent suggestion from early FDA-TRACK work led to the development of FDA-TRACK Dictionaries that provide a plain language explanation for each of the performance measures reported. 5. Knowledge-Sharing – FDA recognizes that we can improve our operational effectiveness through better collaboration and sharing of ideas. The implementation of FDA-TRACK will enable us to identify common issues and interdependencies among our program offices. As a result, program offices are working with one another as well as reaching out to other agencies to collaborate in achieving their performance objectives. FDA-TRACK is a federal level adaptation of successful performance management programs from the state and local level. FDA’s Office of Planning organizes and coordinates the FDA-TRACK process with all of the over 90 program offices across the nine FDA Centers and major offices. Each of the program offices is responsible for collecting and providing monthly data in preparation for reporting performance via the FDA-TRACK dashboard (see Chart 1). The dashboards are presented to senior leadership through quarterly briefings. The data are then posted to the FDA-TRACK website. FDA-TRACK publicly reports performance indicators and related data in four categories: 1. Common Measures – FDA-wide measures that are applicable to each of the over 90 program offices and may focus on the agency’s most recent priorities. Example: increase the total number of employees who are trained in the Incident Command System (ICS), which helps the agency respond to emergencies. 2. Key Center Director Measures – Center-specific measures that are applicable to each Center and are central to the Center’s priorities and strategic goals. Example: increase the FDA’s technical guidance by increasing the number of FDA technical publications, which enables the Center to better communicate with industry and consumers. 3. Program Measures – Program office-specific measures that are applicable to the office and reflect work important to the public and FDA’s mission. Example: increase the percentage of 510(k) (or Class II medical devices) decisions made on time during the month (see Chart 2). 4. Key Projects – Program office-specific projects that are applicable to the office and important to the mission and objectives of the office. Performance for Key Projects is measured through achievement of the stated milestones within the project’s plan. Example: the development of a new risk-based approach for evaluating safety, effectiveness, and quality of new animal drugs. The FDA’s senior leaders are committed to making FDA-TRACK successful and sustainable. To accomplish this goal, FDA anticipates continuing to improve this program so it becomes an everyday essential management tool for all program offices. Planned improvements as FDA-TRACK matures include: ○○ Alignment of FDA-TRACK measures to the annual agency performance measures such as those required by the Government Performance and Results Act of 1993 ○○ Alignment of FDA-TRACK measures to individual employee performance plans ○○ Improvements to FDA-TRACK data management and reporting software ○○ Improvements to measures based on public input and experience so that measures can be more closely tied to the public health mission of the agency ○○ Implementation of improvements to FDA-TRACK performance data analysis to enable better predictive outcomes and other quantitative data-based decision making FDA is working to make FDA-TRACK a model for open government at the federal level. 3. Other FDA Transparency Actions In addition to these initiatives, FDA is planning to post new summary aggregate data resulting from the new Reportable Food Registry, beginning in Q4 FY 2010. The FDA Reportable Food Registry contains information about foods for which there is a reasonable probability that the article of food will cause serious adverse health consequences or death. Regulated industry submits reportable food reports to FDA for possible inclusion in the Registry via an electronic portal. Federal, state, and local government officials may also voluntarily use the electronic portal to report information that may come to them about reportable foods. FDA plans to post reports summarizing certain aggregate data from the Registry online. In Q4 FY 2010, FDA also plans to enable the FDA Recalls website to provide drug, device, and food recall data in XML format to empower users to download, reuse or mash-up recall information. Other Transparency Actions at HHS In addition to the ambitious agendas being pursued by CMS and FDA, other divisions at HHS are pursuing notable new actions with respect to transparency as well: • The Administration on Aging (AoA) will be posting a raw data set from the Annual National Survey of Older Americans Act Participants in Q4 FY 2010. This data has never been posted online in a downloadable format or otherwise been made available to the public as a data set. • The Centers for Disease Control and Prevention (CDC) will be posting a brand new data set -- BioSense Condition-Specific Data, based on reports to the CDC’s BioSense system from participating electronic health records systems (for example, statistics on dental-related emergencies that show up at hospitals). • The Office of the National Coordinator for Health Information Technology (ONC) is in the process of developing a comprehensive performance measurement system and corresponding performance dashboard (ONC Dashboard) for its activities and programs. This Dashboard will assist ONC in monitoring its many programs and grantees, facilitate assessment of progress toward its goals, and position ONC to serve as a leading example of Open Government. In creating the ONC Dashboard, ONC will use information generated by its programs, its internal processes, its formal evaluations and other data collection efforts as needed. Given the wide range of measures to be collected, the Dashboard will have broad capabilities to support different stakeholders’ need for information. ONC’s performance planning is projected to be complete by late spring, with the beta version of the ONC Dashboard launched for public view before the end of 2010.

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