Medicare Data Use Agreement

Data Man­age­ment Plan The DAC devel­ops a data man­age­ment plan and oth­er doc­u­ments nec­es­sary for the ACA sub­mis­sion. Please note that, in some cas­es, oth­er data/variables may be required. For exam­ple, Part D (pre­scrip­tion phar­ma­ceu­ti­cal data) requires a spe­cif­ic vari­able jus­ti­fi­ca­tion. The DAC is respon­si­ble for track­ing and doc­u­ment­ing all DEA cer­tifi­cates and IRB media issued for each project with data stored on DAC servers. The DAC Direc­tor and the DAC Com­pli­ance Coor­di­na­tor are avail­able to audi­tors dur­ing the pre­sen­ta­tion of the DUA pro­ce­dure. Project Col­lab­o­ra­tors Send a com­plete list of peo­ple (name and con­tact infor­ma­tion) to the DAC Com­pli­ance Coor­di­na­tor. Reg­is­ter all peo­ple who work with the data, write papers with the data and/or super­vise some­one who works with the data. 3. You are ask­ing for Aary Research Files (RIF). Why this study does not allow the use of LDS files (Restrict­ed data). Describe why you can only use RIF data to com­plete the study. For more infor­ma­tion, see Res­DAC. 2.1.

Please describe how this cohort meets the min­i­mum required data. Spec­i­fy the approx­i­mate size of the expect­ed cohort (- Benes) to ensure that you do not exceed a 20% sam­ple of the car­ri­er file. 2. Have you ensured that your data request tells the min­i­mum amount of data need­ed to achieve your research goals? List the data need­ed to com­plete the work vol­ume set out in Sec­tion 1. The time­line for approval process­es for CMS-DUA res­DAC appli­ca­tions typ­i­cal­ly lasts at least 3 to 5 months between trans­mis­sion and receipt of data. 2.2. List the files and years of CMS data request­ed at that time and explain how they are used in the scan. List all the “pri­ma­ry” CMS data (DUA ref­er­ence 14049) you request, as well as all deriv­a­tive files (ref­er­ence for the AEA under which they are cur­rent­ly autho­rized) with which you wish to work.

Sum­ma­ry: 1. Sum­ma­ry of stud­ies. Please com­plete this sec­tion by explain­ing in detail the scope of your project‘s work, which usu­al­ly includes a lan­guage spe­cif­ic to the spe­cif­ic research objec­tives and objec­tives of the award. Please note that this should be the same amount of work that was sub­mit­ted on the project review form. All changes to the work­space require up-to-date approval of the project review form. Once the AEA appli­ca­tion is com­plete and the sup­port­ing doc­u­ments pro­vid­ed by the DAC and the prin­ci­pal inves­ti­ga­tor, the fol­low­ing process will take place: 5. If you intend to apply for the Mas­ter Ben­e­fi­cia­ry Sum­ma­ry File‘s Nation­al Death Index, please com­plete the NDI sup­ple­ment. Please con­tact the DAC Direc­tor if you would like to work with the Nation­al Death Index. 2.4. Please list all non-iden­ti­fi­able or non-CMS files that you wish to use for your analy­sis in rela­tion to the above files. Please note that the DAC auto­mat­i­cal­ly lists oth­er poten­tial files you prob­a­bly need for your study.

Note: The DAC Direc­tor and the DAC Com­pli­ance Coor­di­na­tor are avail­able to sup­port this process. Please fol­low these instruc­tions when prepar­ing the study‘s RIF sum­ma­ry form. The instruc­tions fol­low each sec­tion of the form. Is it pos­si­ble to obtain indi­vid­ual autho­riza­tion from Medicare/Medicaid recip­i­ents for your research? Tell me. The DAC will fin­ish this sec­tion for you. Employ­ee Check­list If you work with anoth­er insti­tu­tion, please con­tact the DAC Director.