Update (04/15/2024): CMS continues to receive helpful feedback in response to the updated Request for Information (RFI) (PDF) posted on March 1, 2024. Based on responses we have received to date, we have decided to delay implementation of policy changes, originally planned for August 19, 2024, to not begin before 2025. The additional time will allow CMS to carefully consider and be responsive to comments and concerns in developing the policy changes. CMS also will consider improvements to the research request process and Virtual Research Data Center (VRDC) user experience in conjunction with needed policy updates to strengthen data security. We want to remind and encourage all researchers to send your responses to the questions in the RFI to VRDCRFI@cms.hhs.gov by May 15, 2024.
We plan to share a revised implementation schedule for the policy changes in future guidance, as well as additional details on any adjustments to the policy changes based on researchers’ feedback.
The Centers for Medicare & Medicaid Services (CMS) is announcing two changes to the current research data request and access policies. To review the current CMS Research Identifiable File (RIF) policies please click here (PDF).
Data Dissemination Policy Change for Researchers
BACKGROUND: CMS currently offers researchers two options for accessing CMS Research Identifiable File (RIF) data: (1) researchers can request that physical data extracts are shipped to their institution; and (2) researchers can access the data they need in the Chronic Conditions Warehouse Virtual Research Data Center (CCW VRDC), a secure CMS research environment. Due to growing data security concerns and an increase in data breaches across the healthcare ecosystem, CMS is making changes to the policies around how CMS data is accessed for research.
NEW POLICY: All researchers requesting RIFs must access data within CMS’s CCW VRDC environment and comply with CMS CCW VRDC policies (e.g., only aggregate/statistical information that complies with the CMS cell suppression policy, and is de-identified according to the HIPAA Privacy Rule, may be downloaded from the CCW VRDC). CMS is discontinuing the delivery of physical data extracts in support of external research projects. Only federal and state agencies may request an exception to this policy. CMS will communicate directly with eligible agencies on the process for requesting a policy exception.
IMPLEMENTATION: CMS will implement this policy change in two phases. We plan to share an implementation schedule for this policy change in future guidance, as well as additional details on any adjustments to this policy change based on researchers’ feedback. This policy change will not begin before 2025.
Proposed Phase 1: Phase 1 policy changes include the following:
- CMS will no longer allow the physical dissemination of RIF data for new research studies. All new RIF Data Use Agreement (DUA) requests will be required to access RIF data within the CCW VRDC.
- Research studies with a RIF DUA approved prior to phase 1 implementation, may continue to receive physical data extracts, but researchers cannot request to expand the study to include new types of data. Researchers may only request additional years of physical data previously approved for the study.
- CMS will no longer offer physical shipment of preliminary Medicare Advantage Encounter or preliminary Transformed Medicaid Statistical Information System (T-MSIS) Analytic Files (TAF) data for any research DUAs. Researchers who wish to access these preliminary files must use the CCW VRDC.
Proposed Phase 2: During phase 2, all RIF DUAs approved for physical RIF data extracts prior to the implementation of phase 1, must be closed or transitioned into the CCW VRDC.
Request for Information: CMS has posted an informal Request for Information (RFI) to aid CMS in planning for the implementation of these new policies. The RFI will help CMS better understand the potential issues researchers may encounter when transitioning their projects into the CCW VRDC or with the change in physical data pricing (see below). CMS will use insights gained from the RFI feedback to finalize the implementation plans related to these new policies.
Feedback on the RFI will be accepted until May 15, 2024. Please click here (PDF) to open the RFI. Responses to the RFI must be sent via email to VRDCRFI@cms.hhs.gov.
To learn more about the VRDC, please review the About the VRDC and Requesting Access page on ccwdata.org.
Pricing Changes for Physical Delivery of Research Files:
BACKGROUND: CMS updates the fees for research data requests periodically to account for changes in the costs CMS incurs supporting researcher access to CMS data. In 2021, CMS updated CCW VRDC pricing with the transition to the CCW VRDC Cloud Environment. However, CMS did not update the fees for physical delivery of research files at that time. CMS now needs to update physical data pricing to account for changes to CMS’s costs and to align the physical data pricing approach with the CCW VRDC pricing approach.
NEW POLICY: CMS is implementing a new pricing structure for physical data requests, which will include an annual Project Fee in addition to the current File Dissemination Fees. Fees for access to CMS data are designed to account for the ongoing costs CMS incurs. Costs associated with maintaining the RIF DUA, conducting data privacy and security reviews, and providing Research Data Assistance Center (ResDAC) help desk support are built into a new Project Fee. Costs for building and shipping physical data files are used to calculate the File Dissemination Fees, which are set for each data file.
IMPLEMENTATION: We plan to share an implementation schedule for the pricing changes in future guidance, as well as additional details on any adjustments to the pricing changes based on researchers’ feedback. Pricing changes will not begin before 2025 and may include the following:
- Researchers with previously approved DUAs that have not yet transitioned to the CCW VRDC will be required to pay a Project Fee annually upon their DUA renewal date.
- Researchers will continue to pay File Dissemination Fees when physical data files are being sent.
- For more information on the new pricing structure please click here.