MCDB_APCD_Data_Release_Application_Form_Nongovernmental_062822

Application for Standard Analytic Files from the Maryland Medical Care Data Base (Non-Governmental Applicants)

MHCC Data Request Number
Application Received
Application Approved
Data Obtained
INSTRUCTIONS

Non-Governmental Applicants may request MD APCD Standard Analytics Files by submitting this completed Application, including attachments and the Data Management Plan. MHCC will review the application package to determine whether the request meets the criteria for data release pursuant to COMAR 10.25.05. Review data availability here then calculate the applicable fees here. Review Important notes:
- Incomplete applications will be returned to the Applicant and the request may be delayed.
- All applications require a non-refundable application fee, payable at the time of submission.
- All application attachments will be incorporated into the Data Use Agreement (DUA) that must be signed prior to any MCDB data being transmitted. A draft DUA will be provided to the applicant after this Application is submitted, so that the Applicant can review the terms and conditions.
- COMAR 10.25.05.07A requires that all completed applications be published on the Commission's website while the application is under review, without the data management plan and security measures.
- Requests that include Maryland Medicaid Managed Care data and Medicare Fee for Service data require special consideration that may increase the review timeline.
Data Fee Calculator available to estimate the fee for your data sets. The Data Fee Waiver is available to support those who are unable to access the data for financial hardship. If completing a Data Fee Waiver, please attach it to this application under Attachment H.

This application should only be completed and submitted for Standard Analytic Files. All requests for Custom Data Files should be sent directly to MHCC at mhcc.datarelease@maryland.gov.

List of Required Forms
ATTACHMENT A: PROJECT SCOPE

ATTACHMENT B: MD APCD DATASET REQUESTED

ATTACHMENT C: ADDITIONAL DATA SOURCES AND LINKAGE

ATTACHMENT D: DATA MANAGEMENT PLAN

ATTACHMENT E: USE OF CONTRACTORS AND/OR CONSULTANTS (External Entities)

ATTACHMENT F: APPLICANT QUALIFICATIONS

ATTACHMENT G: ATTESTATION

ATTACHMENT H: INSTITUTIONAL REVIEW BOARD AND DATA FEE DOCUMENTS

PROJECT INFORMATION
Project Title
Scheduled Project Start Date
Scheduled Project End Date
Project Overview
Provide an abstract or brief summary (150 words) of the specific purpose and objectives of the Project.
Applicant

(Agency, Academic Institution, Research Organization, Company, Individual, etc.)
Individual/Organization Name

First NameLast Name
Website
Email Address
example@example.com
Telephone Number  Phone Number
Mailing Address Street Address
City/Town  City State  State Zip Code  Zip code
Principal Investigator/Project Manager

(Individual responsible for the research team using the data)
Name     First Name   Last Name
Title   Type a label
Organization Name   Type a label
E-mail Address   Email
Telephone Number   Area Code   Phone Number
Mailing Address   Street Address
City/Town City  State State  Zip Code Zip
Data Custodian

(person responsible for receiving, organizing, storing, and archiving data)
Name   First Name   Last Name
Title
Organization/Company (if different from Applicant) Name
E-mail Address   Email
Telephone Number   Area Code   Phone Number
Mailing Address   Street Address
City/Town  City  State State  Zip Code Zip
Relationship to Applicant (e.g., Contractor)   Relationship
Project Contact

(person responsible for all communications with MHCC)
Name   First Name   Last Name
Title   Type a label
Organization Name   Name
E-mail Address   Email
Telephone Number   Area Code   Phone Number
Mailing Address   Street Address
City/Town City  State State
Zip Code  Zip

ATTACHMENT A: PROJECT SCOPE

Project Purpose
A. Describe the specific research question(s) you are trying to answer or problem(s) you are trying to solve with the requested data or describe the intended product or report that will be derived from the requested data. If a research project, please list each individual question or aim of the analysis.
B. Briefly describe the purpose(s) for which MD APCD data is sought. Use quantitative indicators of public health importance where possible. For example: variation in costs of care; rates of under or over service utilization; health system performance measures; the effect of public health initiatives, health insurance, etc.
C. Explain in detail how the planned project that will use MD APCD data is in the public interest and give specific examples of how the project will serve the public interest.
d. Explain why the planned project could not be practicably conducted without access to and use of protected health information.
E. Explain why the planned project could not be practicably conducted without waiving any individual authorization required by 45 CFR § 164.508.
Project Methodology
A. Describe the project methodology, including project objectives, relevant study questions, analysis methods, software, groupers, and other analytical tools
b. If required by your funding source or home institution to obtain Institutional Review Board review for your project, provide the information regarding the IRB approval below and attach a copy of the current IRB approval on tab "Attachment H".
IRB Approval End Date
Date
IRB Name and Location
blanks
Publication and Dissemination
A. Do you anticipate that the results of your analysis will be published or made publicly available? If yes, how do you intend to disseminate the results of the study (e.g., publication in a professional journal, poster presentation, newsletter, web page, seminar, conference, statistical tabulation, etc.)?
B. All public displays of MD APCD data, regardless of the medium, must comply with MD APCD's cell size suppression policy, as set forth in the Data Use Agreement. Describe how you will ensure that any public display will suppress every cell containing less than 11 observations and suppress percentages or other mathematical formulas that result in the display of every cell with less than 11 observations.
C. Identify the lowest geographical level of analysis of data you will present for publication or presentation (e.g., state level, city/town level, zip code level, etc.). Will maps be presented? What methods will be used to ensure that individuals cannot be re-identified in this publication or presentation?
If you answer "yes" to any of the following questions, describe the types of products, software, services, or tools and what the corresponding fees will be for such products, software, services, or tools.
A. Will the MD APCD data be used for consulting purposes?
B. Will report(s), website(s), or statistical tabulation(s) using MD APCD data be shared or sold?
C. Will a software product using MD APCD data be shared or sold?
D. Will MD APCD data be used as input to develop a product (i.e., severity index tool, a risk adjustment tool, a reference tool, etc.)?
E. Will MD APCD data be sold or shared in any format not noted above? If yes, in what format and who are the purchasers of the data?
f. Will the project result in disclosing MD APCD data, or any data derived or extracted from such data, in any paper, report, website, a statistical tabulation, seminar, or another setting that is not disseminated to the public?
G. Will the results from the project be used for the purpose of price transparency?
H. Will health care providers be individually identified? If yes, describe your protocol for informing health care providers prior to publication of this data/report.
Funding Sources
A. What is the source of funding that supports this project? Provide detailed information about potential and actual sources.
B. Describe any data sharing or other requirements imposed by the above funding sources as a condition for receipt of funding?
c. Please upload documentation that includes grant number, a budget, and any information that shows the available funding for this project.

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Data Security
A. Explain how your use of data will involve no more than a minimal risk to the privacy of individuals. As part of your response, please address how you will protect the data from improper use or disclosure and assure that the data will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research for which the data was requested, or for other research for which the use or disclosure of PHI would be permitted under 45 CFR 164.512(i)(2)(ii).

ATTACHMENT B: MD APCD DATASET REQUESTED
The MD APCD contains fully processed records for eligibility and professional, institutional, and pharmacy claims for privately fully-insured and non-ERISA self-insured health insurance plans licensed in Maryland for both in-state and out-of-state covered members. Please review the data dictionary before completing this section. Calendar years 2010-2021 are currently avaliable.

MD APCD Data Dictionary:https://mhcc.maryland.gov/mhcc/pages/apcd/apcd_data_release/documents/User_Manual_2019_V1_Codebook.pdf

Standard Analytic Files: Formerly known as the Standard Data Extract. The Standard Analytics Files contain four fixed (i.e., non-customizable) files- the Medicaid Eligibility File, the Professional Services File, and the Pharmacy File. Information about the specific data elements provided within each of the four files can be found in the Data Dictionary. This data set does not include data from Medicare.

Custom Data Sets: A custom data extract can be created based on criteria provided by an Applicant if the data are deemed the minimum amount necessary for an Applicant's proposed use of the data and includes:

a. Indirect individual identifiers that cannot be used to identify indviduals when combined with other information or data; or

b. Aggregate, summary data in which the risk of identifying individuals is minimal.

Custom Data Sets can also include requests for linkage across data sets.

This application should only be completed and submitted for Standard Analytic Files. All requests for Custom Data Files should be sent directly to MHCC at mhcc.datarelease@maryland.gov.
Which MD APCD files are you requesting? Provide a brief justification (1-3 sentences) for each one. Specifically address why this is the minimum necessary data to accomplish the study.
Institutional Claims

MedicaidCommercial
Years of Institutional Claims (Specify for Medicaid and Commercial if different)
Justification for Requesting Institutional Claims
Professional Claims

MedicaidCommercial
Years of Professional Claims (Specify Medicaid and Commercial if different)
Justification for Requesting Professional Claims
Pharmacy Claims

MedicaidCommercial
Years for Pharmacy Claims (Specify Medicaid and Commercial if different)
Justification for Requesting Pharmacy Claims
Member Eligibility

MedicaidCommercial
Years for Member Eligibility (Specify Medicaid and Commercial if different)
Justification for Requesting Member Eligibility

ATTACHMENT C: ADDITIONAL DATA SOURCES AND LINKAGE
1. Maryland Medicaid Managed Care Data
Applications for access to Medicaid Managed Care data are sent to the Maryland Medicaid Administration for review and comment. The fields avaliable on the Medicaid MCO data sets have been aligned with Maryland APCD fields to the extent greatest possible. Medicaid Fee for Service data sets are not avaliable.
A. Are you requesting Medicaid data?

YesNo
B. Do you intend to merge or link Maryland APCD data with Medicaid data?

YesNo
If yes, provide a brief justification.
C. Describe how the requested Medicaid Managed Care Data meet the minimum necessary standard.
D. Federal law (42 USC 1396a (a) 7) restricts the use of individually identifiable data of Medicaid recipients to uses that are directly connected to the administration of the Medicaid program. If you are requesting Maryland Medicaid Data, please describe, in the space below, why your use of the Data meets this requirement.
2. Medicare Data
If requesting Medicare data, the request will be reviewed in accordance with the State Agency DUA and CMS State Data Request Memo. Per the CMS State Data Request Memo, researchers that are not doing work under the direction of the state will need to request the data through the current CMS research request process. Additionally, researchers in states that receive data under this process for studies that are under the direction of, and are partially funded by a state, will still be required to request the data through the current CMS research request process for other studies that are conducted under different authorities or funding.
A. Are you requesting Medicare Data?

YesNo
B. If yes, identify the Maryland agency or official under whose direction you are conducting this research and receiving funding:
3. Other Linkages
A. Do you intend to merge or link Maryland APCD Data with other data?

YesNo
i. What are the files to be linked?
ii. Why is this linkage needed?
B. Which Maryland APCD data elements will be linked to the data elements in the external file?
C. What methodology or algorithm will be used to create this match? If you intend to create a unique algorithm, describe how it will link each dataset.
D
E. Describe the specific steps the Organization will take to prevent the identification of individuals in the linked files.
. Describe the specific steps the Organization will take to prevent the identification of individuals in the linked files.

ATTACHMENT D: DATA MANAGEMENT PLAN
The undersigned certifies and agrees as follows:
- The data will be used for approved purposes of analysis and presentation.
- The Organization will comply with all administrative, technical, and procedural policies and physical safeguards established to protect the confidentiality of the data and to prevent unauthorized access to the data.
- The data will be encrypted at rest and in motion on storage media (backup tapes, local hard drives, network storage, et al.) with at least an AES-256 standard or stronger.
- The Organization understands and agrees that any intentional breach of confidentiality will result in termination of the Data Use Agreement.
- Anti-virus software or service is active on any server or endpoint containing the MD APCD data.
- Staff with access to PHI or other sensitive data have received all relevant training.
- The Orgnaization has policies and procedures in place to address:
  - The sharing, transmission, and distribution of PHI
  - The physical possession and storage of PHI
  - The destruction of PHI upon completion of data use.
  - Confidentiality agreements with each individual, including contractors, who will access PHI
  - Agreements governing the use and disclosure of PHI with all non-employees who will access PHI
Confirm you certify and agree to the above statement.*

Yes

Responsible Individuals
Provide the name(s) of the custodian responsible for receiving, organizing, storing, or archiving data.

Custodian
Name    First Name   Last Name
Title Title
E-mail Address Email
Telephone Number Area Code   Phone Number
Organization Name Organization Name
Mailing Address Street Address
City/Town City  State State
Zip CodeZip
Provide the Name of the person who will notify MHCC of any breach of the MD APCD data, Data Use Agreement, or the Data Management Plan.

Notifications
Name    First Name   Last Name
Title Title
E-mail Address Email
Telephone Number Area Code   Phone Number
Organization Name Organization Name
Mailing Address  Street Address
City/Town City  State State
Zip Code Zip
Provide the name of the person responsible for ensuring proper data destruction upon the termination of the Data Use Agreement, and submission of the Certification of Data Destruction.

Individual Responsible for Data Destruction
Name    First Name   Last Name
Title Title
E-mail Address Email
Telephone Number Area Code   Phone Number
Organization Name Organization Name
Mailing Address Street Address
City/Town City  State State
Zip CodeZip
Provide the name of the person who will notify MHCC of any project staffing changes, maintain the roster of staff who have formal, documented permission to access specific files for specific purposes, and ensure that all individuals with access to the data comply with the Data Use Agreement.

Name    First Name   Last Name
Title Title
E-mail Address Email
Telephone Number Area Code   Phone Number
Organization Name Organization Name
Mailing Address Street Address
City/Town City State State
Zip Code Zip

Physical Possession and Storage of Data Files
Where will the data be stored?

CloudPhysical Location(s)Both
Delivery address for data files:
Contact Person:    First Name   Last Name
Company/Organization: Organization Name
Mail Address: Street Address
City/TownCity  State State
Zip Code Zip
Storage Address
Name if Different from Delivery: Full Name
Mail Address:Street Address
City/Town City  State State
Zip Code Zip
Cloud Service Provider
Name of Cloud Service:   Type a label
Mail Address:Street Address
City/Town City  State State
Zip CodeZip

ATTACHMENT E: USE OF CONTRACTORS AND/OR CONSULTANTS (External Entities)
Provide the following information for all consultants and contractors who will have access to the Maryland APCD data. The Requesting Organization must have a written agreement with the contractor/consultant to ensure the use of MD APCD data only for the approved project(s) of this application as well as the privacy and security standards set forth in the Data Use Agreement. MD APCD data may not be shared with any third party without prior written consent from MHCC, or an amendment to this application.
Entity   Contractor   Subcontractor   Consultant
Organization Name Organization Name
Title Type a label
Website   Website
Contact Person  Full Name
E-mail Address Email
Telephone Number Area Code  Phone Number
Mailing AddressStreet Address
City/Town City State  State
Zip Code Zip
Term of Contract Type a label
1. Describe the tasks and products assigned to this entity for this project.
2. Describe the qualifications of this entity to perform and complete the tasks.
3. Describe the Requesting Organization's oversight and monitoring of the activities and actions of this entity for this project, including how you will ensure the privacy and security of the MD APCD data to which the consultant or contractor has access.
4. Will this entity have access to or store the MD APCD data at a location other than the data custodian location, off-site server, and/or database?

YesNo
If yes, a separate Data Management Plan must be completed by this contractor/consultant.

ATTACHMENT F: APPLICANT QUALIFICATIONS
Describe previous experience using claims data. This question should be answered by the primary investigator/project manager and should encompass the experience of the entire project team who will be using the data.
Resumes/CVs: When submitting your Application package, include resumes or curricula vitae of the principal investigator/project manager and any project team with relevant experience,

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Project Personnel

Has the Applicant or any person or entity that is an officer, owner, operator, or part of management of the applicant's organization who will have access and use of the data been subject of or a party to a state or federal regulatory agency action or civil or crimincal action involving a data breach, HIPAA violation, or other matter involving unauthorized access, use, and disclosure of data regardless of whether there has been a finding or admission of guilt, including being:
- Convicted of a felony or pleading guilty, or receiveing a diversionary disposition regarding a felony;
- A subject of an investigation conducted by, or a pending complaint, charge, or indictment issued by, a local, state, or federal governmental regulatory agency or other state or federal law enforcement agency; or
- A party to a final dispositive action in a state or federal governmental agency regulatory action or a civil action that resulted in entry into a settlement agreement, consent agreement, decree or order, corporate integrity agreement, corrective action agreement, or other similar agreement or other disposition in a civil action regardless of whether there has been an admission or finding of guilt or liability.
If yes, provide additional information here:

ATTACHMENT G: ATTESTATION
ATTESTATION OF APPLICANT

I, blanks, solemnly affirm under penalties of perjury that:

1. I am either submitting this application in my individual capacity or am an officer of the Applicant's organization that has signatory authority to bind the applicant;

2. The contents of this application and any supplementary information are true and correct to the best of my knowledge, information, and belief; and

3. The requested MD APCD data is the minimum necessary to accomplish the Project.
Signature   Signature
Printed Name   First Name   Last Name
Title   Type a label
Date   Date

ATTACHMENT H: INSTITUTIONAL REVIEW BOARD AND DATA FEE DOCUMENTS
A. Institutional Review Board Determination

Letter and Supporting Materials
If applicable, insert copy of a current IRB determination letter accompanied by documentation submitted by the Applicant for that determination. All project information fields on the IRB materials must match those submitted on this data request.

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B. Data Fee Quote
If you have completed the Data Fee Calculator and saved the PDF, upload the PDF as a cost quote for our records. If this application is approved, the final total cost will be sent by MHCC.

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C. Data Fee Waiver
If you have completed the Data Fee Waiver and saved the PDF, upload it below for our review. MHCC will reach out to you to discuss next steps.

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When you submit this application, a draft DUA will be produced for your review of the terms and conditions. There is no action needed on the DUA at this time. If your application is approved, MHCC will send you a final formal DUA for execution.
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Application for Standard Analytic Files from the Maryland Medical Care Data Base (Non-Governmental Applicants)

List of Required Forms

PROJECT INFORMATION

Applicant

Principal Investigator/Project Manager

Data Custodian

Project Contact

ATTACHMENT A: PROJECT SCOPE

Data Security

ATTACHMENT B: MD APCD DATASET REQUESTED

ATTACHMENT C: ADDITIONAL DATA SOURCES AND LINKAGE

ATTACHMENT D: DATA MANAGEMENT PLAN

Completion of Research Tasks and Data Destruction

ATTACHMENT E: USE OF CONTRACTORS AND/OR CONSULTANTS (External Entities)

ATTACHMENT F: APPLICANT QUALIFICATIONS

Project Personnel

ATTACHMENT G: ATTESTATION

ATTESTATION OF APPLICANT

ATTACHMENT H: INSTITUTIONAL REVIEW BOARD AND DATA FEE DOCUMENTS