CMS Data Availability and Request Process David Lanctin, M.P.H. Technical Advisor ResDAC, University of Minnesota Work performed under CMS Contract #HHSM-500-2013-00166C
Objectives CMS privacy levels and which apply to MAX? Research Identifiable File (RIF) request process: ˗ How to request new DUA? ˗ What are the options for accessing RIF data? ˗ Who should you include in your study cohort? ˗ How to amend your DUA? 2 Work performed under CMS Contract #HHSM-500-2013-00166C
Privacy Levels of CMS Data Public Use Files Limited Data Sets Research Identifiable Files 3 Work performed under CMS Contract #HHSM-500-2013-00166C
Privacy Levels and Available Files: Public Use Files ˗ Highly aggregated or de-identified ˗ Downloadable or very simple ordering process ˗ Free or small charge ˗ Examples: » Medicare: Provider of Services, Shared Savings Plan ACO PUF, Part B Summary Data Files, Cost Reports » Medicaid: MSIS statistics, MAX PC, MAX ESPC » General: NPI database 4 Work performed under CMS Contract #HHSM-500-2013-00166C
Privacy Levels and Available Files (cont) Limited Data Sets ˗ Medicare only – not available for Medicaid Beneficiary-level claims and enrollment ˗ ˗ Stripped of identifiable or potentially identifiable data elements » Zip code » Exact dates of birth » Beneficiary identifiers ˗ Require request of DUA » LDS DUAs requested directly through CMS: https://www.cms.gov/Research-Statistics-Data-and- Systems/Computer-Data-and-Systems/Privacy/DUA_-_LDS.html 5 Work performed under CMS Contract #HHSM-500-2013-00166C
Privacy Levels and Available Files (cont) Research Identifiable Files ˗ Medicaid Enrollment and claims » MAX files: PS, IP, LT, OT, RX » Medicaid Enrollee Supplemental File • National Death Index (1999-2007) • Chronic Conditions Segment • Flags generated by CCW (documentation on website) • Total of 60 conditions including Mental Health, Tobacco use, and Physical/Mental Disability » Mini-MAX 2008 • National only • 5% sample, stratified by state and eligibility group • No longer produced, 2008 only year available 6 Work performed under CMS Contract #HHSM-500-2013-00166C
Privacy Levels and Available Files (cont) Other Research Identifiable Files ˗ Medicare/Medicaid Linked file – MMLeads » Summary enrollment and utilization » Medicare only, Duals, Medicaid only disabled ˗ Medicare claims and enrollment ˗ Assessments: MDS nursing facility, MDS swing bed assessments, OASIS home health, IRF-PAI rehab facility ˗ All link to MAX data by Bene_ID 7 Work performed under CMS Contract #HHSM-500-2013-00166C
RIF DUA Request Process 8 Work performed under CMS Contract #HHSM-500-2013-00166C
Data Access Options Physical Receipt ˗ Shipment on disk or portable hard drive http://www.resdac.org/cms-data/request/research- identifiable-files Virtual Research Data Center (VRDC) ˗ Virtual research environment within CMS’ Chronic Condition Data Warehouse http://www.resdac.org/cms-data/request/cms-virtual- research-data-center 9 Work performed under CMS Contract #HHSM-500-2013-00166C
What is a DUA? Data Use Agreement (DUA) ˗ Legal agreement between CMS and the requesting organization that outlines terms for using CMS data ˗ DUAs cover specific files, cohort, and years ˗ DUAs are study specific ˗ Both LDS and RIF requests establish a DUA 10 Work performed under CMS Contract #HHSM-500-2013-00166C
Types of Requests Overview New Study Request ˗ Each DUA is study specific, a new study requires a new DUA ˗ New DUA can be established via new use (purchasing new data) and/or reuse (reusing data already held at your institution) Amendment Request ˗ Researcher requests changes to an existing DUA ˗ There are numerous types of amendment requests 11 Work performed under CMS Contract #HHSM-500-2013-00166C
New Study Requests 12 Work performed under CMS Contract #HHSM-500-2013-00166C
Overview of RIF Request Process Access to RIF data requires a formal data request ˗ Multiple request avenues » Regular Research » Innovator Research (VRDC-only) » Others A request, if approved, will establish a DUA with CMS for a particular study Plan for a minimum of 3-4 months between request submission and receipt of data ˗ Timeline is 1-2 months longer under Innovator Research program 13 Work performed under CMS Contract #HHSM-500-2013-00166C
Overview of Request Process Researcher ResDAC DPSP CMS CCW Contractor Draft DMP Review Packet Packet Reviews Revisions Final Packet CMS Analyst Privacy Board Decision Payment Notification Confirmation Processing 14 Work performed under CMS Contract #HHSM-500-2013-00166C
ResDAC Review of Materials Review Criteria ˗ Are the files appropriate to meet study objectives? ˗ Are the request materials complete and consistent? ˗ Minimum Data Necessary? 15 Work performed under CMS Contract #HHSM-500-2013-00166C
Cohort Selection Minimum Data Necessary Policy ˗ Rarely a 100% file ˗ Limit data to those necessary to achieve study aims » Limited number of states AND/OR » Specific age groups AND/OR » Eligibility groups AND/OR » Disease specific conditions can be selected by: – Diagnosis codes – Procedure codes – Prescription drugs – Combination of criteria 16 Work performed under CMS Contract #HHSM-500-2013-00166C
Cohort selection (cont) Substance Abuse and Mental Health Services Administration (SAMHSA) regulations ˗ Under the Confidentiality of Alcohol and Drug Abuse Patient Records Regulations, 42 CFR Part 2, CMS cannot disclose or allow the use of patient identifiable information from alcohol or drug abuse patient records for research purposes without patient consent. ˗ What this means for research with MAX data » Default process is to redact any claims with SAMHSA sensitive procedures or diagnosis codes » List is posted on the ResDAC web site along with statistics about the impact on the data » Alternative process if you need full data on these beneficiaries 17 Work performed under CMS Contract #HHSM-500-2013-00166C
New Data Request – Required Materials All new study requests require the following documents: Request Letter Executive Summary Data Management Plan Study Protocol Data Use Agreement & Signature Addendum DUA Attachment B IRB Documentation Evidence of Funding Specifications Worksheet (may not be required for reuse) Cost Invoice 18 Work performed under CMS Contract #HHSM-500-2013-00166C
New Data Request – Additional Materials Depending on the request circumstances, researchers may also need the following. Not all of these documents will be required for all requests. Reuse se Requ ques ests ts Letter from Original Requestor Letter from Original Federal Project Officer Fi File le-Speci Specific ic Do Docu cumen enta tati tion on Par art D J t D Just stifica ificati tion on Assessment Variable Justification National Death Index Supplemental Application Name and Address file 19 Work performed under CMS Contract #HHSM-500-2013-00166C
Preparing to Submit a Request Packet Finalize request details – talk to ResDAC! ˗ Who is in your cohort? ˗ What files do you need? ˗ What years do you need? ˗ Are you reusing any data? Obtain a cost estimate Secure funding for data request Begin IRB review process Begin data management plan preparation 20 Work performed under CMS Contract #HHSM-500-2013-00166C
Submitting a New Request Packet Download required materials from ResDAC website Complete materials and email dr draf aft t ver ersions sions (unsigned) to resdac@umn.edu Your request will be assigned to ResDAC staff who will be in touch after reviewing request 21 Work performed under CMS Contract #HHSM-500-2013-00166C
Amendment Requests 22 Work performed under CMS Contract #HHSM-500-2013-00166C
Overview of Amendment Process As mentioned, DUAs are study specific and cover only the files, cohort, and study objectives outlined to CMS at the time of DUA request Any changes to what was originally requested/described require formal approval from CMS The process for requesting these changes is an amendment request ˗ Similar to new DUA request with less documents ˗ 2-3 month processing time 23 Work performed under CMS Contract #HHSM-500-2013-00166C
Amendment Request Types There are several different types of amendment requests. Most common include requests to: – Add additional years of data files previously approved under DUA – Add new data not previously approved under the DUA – Update the data management plan – Update study objectives 24 Work performed under CMS Contract #HHSM-500-2013-00166C
Adding Additional Years of Data Researchers can only request data that is available at the time of request After a DUA is established, it is not uncommon to request additional years of data as they become available These requests do not require CMS Privacy Board review Necessary Request Documents: Written request letter ˗ ˗ DUA Update form ˗ Specifications Worksheet ˗ Cost Invoice ˗ Letter from federal project officer (if federally funded) 25 Work performed under CMS Contract #HHSM-500-2013-00166C
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