At Datapalooza on June 2, 2015, Andy Slavitt, the acting Administrator for the Centers for Medicare & Medicaid Services (CMS), announced a new policy that would for the first time allow “innovators and entrepreneurs” to access CMS data. Couched as part of the Administration’s “commitment to use data and information to drive transformation of the healthcare delivery system,” CMS will now accept applications for researchers, regardless of their affiliation or funding, to use Medicare claims data to create products they intend to sell. The goal of the initiative is to promote innovation and insights from CMS data that will result in the development of tools that could benefit patients and the healthcare system overall.
Prior to this announcement, commercial entities could not directly access data and researchers funded by commercial entities had to attest that they would limit data sharing with the funding entity to aggregated analytic results and would retain the right to independently prepare publications of the study results. Moreover, these results could not be used in a commercial tool or product. Being able to work within the broader dataset and create population health products will certainly move the field further, faster.
But this does not mean that anything goes. To gain access, “innovators” must first submit a full application for the data based on a bona fide research question with the intent to disseminate findings as “generalizable knowledge.” This is not a process for the faint of heart. The application requires a request letter, documentation of research questions and methods, a data use agreement, cost estimates and disclosures of funding, and prior approval by the Institutional Review Board (IRB). There a lot of forms to be filled out, and questions from the Research Data Assistance Center (ResDAC) staff that will need to be answered.
Many of these efforts can be made easier for researchers that partner with corporate entities. With the right partner, researchers can gain access to corporate resources to complete the application and supplemental materials describing the intended commercial use of the results. And they will have a partner that can assume the risk for investing in product development, marketing and sales based on findings.
Although CMS has not explicitly stated what commercial purposes they will approve, they are clearly trying to get products and services that will use data to “drive transformation of the healthcare delivery system,” including those that “improve care and personalize decision-making.” So, researchers who select a partner that intends to use the insights to create population health analytics such as care management or predictive modeling tools, for example, could increase the likelihood of an approved application.
Secondarily, researchers may also want to consider corporate partners that may have access to their own data to bring to the research question. CMS has said that although researchers won’t be allowed to take possession of the raw data and will have to complete work in the Virtual Research Data Center (VRDC), they will be allowed to load their own data into the VRDC. For instance, if an approved researcher wants to match clinical information to the claims data, that data can be uploaded and worked with in the VRDC to enhance the findings.
This is an important and exciting development. CMS is now willing to let any sound researcher, whether they work with a commercial entity or a non-profit organization, access their treasure trove of data. I, for one, can’t wait to see the innovations such a policy inspires.
Written by Danielle Lloyd, vice president for policy and advocacy as well as deputy director of the Washington, DC office of the Premier healthcare alliance. Premier, Inc. (NASDAQ: PINC) is a leading healthcare improvement company, uniting an alliance of approximately 3,400 U.S. hospitals and 110,000 other providers to transform healthcare. She is an AcademyHealth member and serves on our Committee on Advocacy and Public Policy, a standing committee of the Board of Directors that advises the Board and staff on the development of the organization's guiding principles and policy priorities, the formulation of policy positions, and the implementation of advocacy strategies.