CMS Data Availability and Request Process David Lanctin, M.P.H. - - PowerPoint PPT Presentation

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CMS Data Availability and Request Process David Lanctin, M.P.H. - - PowerPoint PPT Presentation

Sep 21, 2022 252 likes •576 views

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

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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

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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?

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Work performed under CMS Contract #HHSM-500-2013-00166C

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Privacy Levels of CMS Data

  • Public Use Files
  • Limited Data Sets
  • Research Identifiable Files

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Work performed under CMS Contract #HHSM-500-2013-00166C

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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

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Work performed under CMS Contract #HHSM-500-2013-00166C

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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

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Work performed under CMS Contract #HHSM-500-2013-00166C

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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

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Work performed under CMS Contract #HHSM-500-2013-00166C

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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

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Work performed under CMS Contract #HHSM-500-2013-00166C

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RIF DUA Request Process

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Work performed under CMS Contract #HHSM-500-2013-00166C

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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

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Work performed under CMS Contract #HHSM-500-2013-00166C

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What is a DUA?

  • Data Use Agreement (DUA)

˗ Legal agreement between CMS and the requesting

  • rganization 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

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Work performed under CMS Contract #HHSM-500-2013-00166C

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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

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Work performed under CMS Contract #HHSM-500-2013-00166C

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New Study Requests

Work performed under CMS Contract #HHSM-500-2013-00166C

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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

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Work performed under CMS Contract #HHSM-500-2013-00166C

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Overview of Request Process

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Researcher ResDAC DPSP Contractor CMS CCW Draft Packet Packet Revisions Reviews Final Packet CMS Analyst Privacy Board Decision Notification Payment Confirmation DMP Review Processing

Work performed under CMS Contract #HHSM-500-2013-00166C

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ResDAC Review of Materials

  • Review Criteria

˗ Are the files appropriate to meet study

  • bjectives?

˗ Are the request materials complete and consistent? ˗ Minimum Data Necessary?

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Work performed under CMS Contract #HHSM-500-2013-00166C

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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

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Work performed under CMS Contract #HHSM-500-2013-00166C

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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

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Work performed under CMS Contract #HHSM-500-2013-00166C

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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

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Work performed under CMS Contract #HHSM-500-2013-00166C

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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

  • n
  • Par

art D J t D Just stifica ificati tion

  • n
  • Assessment Variable Justification
  • National Death Index Supplemental Application
  • Name and Address file

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Work performed under CMS Contract #HHSM-500-2013-00166C

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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

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Work performed under CMS Contract #HHSM-500-2013-00166C

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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

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Work performed under CMS Contract #HHSM-500-2013-00166C

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Amendment Requests

Work performed under CMS Contract #HHSM-500-2013-00166C

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Overview of Amendment Process

  • As mentioned, DUAs are study specific and cover
  • nly 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

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Work performed under CMS Contract #HHSM-500-2013-00166C

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Amendment Request Types

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  • 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

Work performed under CMS Contract #HHSM-500-2013-00166C

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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)

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Work performed under CMS Contract #HHSM-500-2013-00166C

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Adding Data not Previously Approved

  • Occasionally, researchers may need to request new

data (new files or new cohort) not originally approved

  • These requests may require re-review by CMS Privacy

Board

  • Necessary Request Documents:

˗ Written request letter ˗ DUA Update form ˗ Specifications Worksheet ˗ Cost Invoice ˗ Letter from federal project officer (if federally funded) ˗ Updated Executive Summary

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Work performed under CMS Contract #HHSM-500-2013-00166C

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Updating the Data Management Plan

  • Occasionally, organizations need to make changes

to the data management plan that was approved.

  • Necessary documents include:

˗ Written request letter ˗ Updated Data Management Plan of Executive Summary ˗ Letter from federal project officer (if federally funded)

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Work performed under CMS Contract #HHSM-500-2013-00166C

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Amendments Not Processed By ResDAC

  • Personnel changes to the DUA

˗ This should be handled with CMS directly, see “Contact Changes” ˗ http://www.cms.gov/Research-Statistics-Data-and- Systems/Computer-Data-and-Systems/Privacy/DUA_- _Contact_Changes.html

  • Annual extensions to the DUA

˗ This should be handled with CMS directly. See “Extensions & Closures” ˗ http://www.cms.gov/Research-Statistics-Data-and- Systems/Computer-Data-and-Systems/Privacy/DUA_- _Extensions_Closures.html

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Work performed under CMS Contract #HHSM-500-2013-00166C

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Submitting an Amendment 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

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Work performed under CMS Contract #HHSM-500-2013-00166C

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Resources for Help

  • ResDAC Website

˗ CMS Data Request Center

» NEW >> Tips documents for each request document

˗ ResConnect (Resource Library)

» Tips for Completing a RIF Request Packet

˗ Webinar on Requesting Data ˗ Pricing Information

  • CCW Website

˗ Estimate Study Size (only available for Medicare) ˗ Medicare & Medicaid Tables & Reports

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Work performed under CMS Contract #HHSM-500-2013-00166C

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Resources for Help

  • ResDAC Assistance Desk

˗ Email: resdac@umn.edu ˗ Phone: 1-888-973-7322 ˗ Web: http://www.resdac.org

  • ResDAC Requesting Data Page

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Work performed under CMS Contract #HHSM-500-2013-00166C