Attachment B November 9, 2022

Amendment Effective Date: February 13, 2023

Utah Parkinson’s Disease Registry Department of Health and Human Services

Healthy Aging Program FY23-FY28 Special Provisions

I. DEFINITIONS

A. AAN means the American Academy of Neurology.

B. AMA means the American Medical Association.

C. APCD means the All-payer Claims Database.

D. APDF means the American Parkinson’s Disease Foundation.

E. Bi-monthly means every other month.

F. BMIC means Biomedical Informatics Core.

G. BRFSS means the Behavioral Risk Factor Surveillance System.

H. CONTRACTOR means UMC Neurology Department, University of Utah and is the Sub-

Recipient as defined and described in Attachment A, Utah Department of Health General Provisions Sub-Recipient.

I. DEPARTMENT means the Utah Department of Health, Healthy Aging Program.

J. DTS means the DHHS Department of Technology Services.

K. HAP means the Utah Department of Health and Human Services, Healthy Aging

Program.

L. HIPAA means the Health Insurance Portability and Accountability Act of 1996, a federal law that required the creation of national standards to protect sensitive patient health information from being disclosed without the patient's consent or knowledge.

M. IBIS means the Indicator-Based Information System for Public Health (IBIS-PH).

N. PD means Parkinson’s Disease. A disease characterized as a progressive motor disability manifested by tremors, shaking, muscular rigidity, and lack of postural reflexes.

O. R384-300 is the Parkinson's Disease Reporting Rule.

P. REDCap means the Research Electronic Data Capture secure web application for building and managing online surveys and databases.

Q. UPDR means Utah Parkinson’s Disease Registry.

R. UPDRAC means the Utah Parkinson’s Disease Registry Advisory Committee.

II. PAYMENTS

A. The DEPARTMENT shall pay the CONTRACTOR not to exceed the contract amount of $1,050,000 for services provided by the CONTRACTOR directly related to this project as described in Section III.

1. Funds can only be used as follows:

a) $210,000 for the period November 9, 2022 – June 30, 2023.

b) $210,000 for the period July 1, 2023 – June 30, 2024.

c) $210,000 for the period July 1, 2024 – June 30, 2025.

d) $210,000 for the period July 1, 2025 – June 30, 2026.

e) $210,000 for the period July 1, 2026 – June 30, 2027.

2. The contract is paid with 100% state funds.

3. No more than 10% of funds are allowed on facilities and administration

(indirect).

B. Upon execution of the contract amendment the CONTRACTOR shall invoice the DEPARTMENT for the activities performed according to the agreement for the amount of $52,500.

C. The CONTRACTOR shall invoice the DEPARTMENT for the amount of $52,500 each quarter on the following schedule:

Quarter 1: July 1 – September 30, due on or by October 15 Quarter 2: October 1 – December 31, due on or by January 15 Quarter 3: January 1 – March 31, due on or by April 15 Quarter 4: April 1 – June 30, due on or by June 15

III. SERVICES

The CONTRACTOR shall:

A. Convene the Utah Parkinson’s Disease Registry Advisory Committee (UPDRAC)

1. Chair and convene the UPDRAC to advise and make recommendations related to surveillance, reporting, reporting requirements, and develop a case definition. Advisory Committee shall include but not limited to:

a) PD patient representative or a PD patient caretaker

b) PD researcher outside of the University of Utah healthcare network

c) DEPARTMENT representative

2. By June 30, 2023, the UPDRAC shall develop and disseminate to all stakeholders a 5-year strategic plan outlining the UPDR goals, objectives, activities, and outcomes.

a) Provide annual updates on the outcomes and performance measures identified in the strategic plan and disseminate to stakeholders.

3. Investigate funding opportunities to apply for to increase sustainability.

B. Complete recruitment and manage the following staff or combination of staff:

1. Principle Investigator

2. PD Scientist/Epidemiologist

3. Data Outreach and Coordinator

4. Data Quality and Input Staff

5. REDCap Database Scientist

C. Increase awareness of the R384-300 reporting rule and enrollment in the UPDR

1. Develop a campaign to increase awareness among healthcare providers.

a) Establish a list of practicing neurologists in the state of Utah from the AMA, AAN and state sources to use for outreach.

b) Ensure that physicians within 90% of the counties in Utah have received information regarding the PD reporting requirements.

D. Surveillance

1. Create and annually monitor benchmarks.

2. Work with the DEPARTMENT to gain access to the raw data every six months or as needed for reports.

a) CONTRACTOR will work with the DEPARTMENT to provide access to

REDCap or will provide an exported data file.

3. Provide ongoing surveillance and evaluation in order to develop projects such as, but not limited to the following outcomes in order to present to partners, legislators, and as requested:

a) Understand the rise in PD in Utah.

b) Uncover causes of the disease. (genetic and environmental causes)

c) Determine if PD affects ethnic or other populations groups differently.

d) Track trends of PD.

e) Collaborate with DEPARTMENT to conduct 1-2 evaluation projects.

4. Manage Data and Requests

a) Manage and maintain the UPDR website at http://updr.org/ and backend REDCap database, including ensuring the security certificate is up-to-date.

b) Provide raw data to the DEPARTMENT within 10 business days of each request.

c) Annually collect data for no less than 1,000 PD patients. Data to be collected shall include the following:

(1) Demographic data:

(a) First name

(b) Middle Name or Initial

(c) Last name

(d) Year of onset of symptoms

(e) Year of diagnosis

(f) Year of visit (patient seen for any reason with a diagnosis of PD)

(2) Current address:

(a) Address (Street)

(b) Apartment number (if needed)

(c) City

(d) State

(e) Zip code

(3) Birth data:

(a) Date of birth

(b) County at time of birth

(c) State at time of birth

(4) Residence history:

(a) County of residence for the majority of time (last 10 years)

(b) State of residence for the majority of time (last 10 years)

(5) Contact information:

(a) Would you like to be contacted regarding available information and resources for Parkinson’s disease?

(6) Submission information:

(a) Who is submitting this form?

(7) Other, as determined by the Advisory Committee or other legislative request.

E. HIPAA Standards

1. The UPDR must provide transaction logging (i.e. audit trails).

2. For audit purposes, the UPDR must log the following information for all queries requested, responses provided and records accessed:

a) User ID

b) Date and Time

c) Field

d) Values Requested

e) Results Returned

3. The UPDR must create an audit log to track changes to existing records. For audit purposes, the system must log the following information for all record creations, updates, and deletions made:

a) User ID

b) Date and Time

c) Field(s)

d) Modification type (create, update, delete)

e) Original value

f) New value

4. The UPDR must record and display the User ID, workstation, date and time each user successfully logged onto the system.

5. The UPDR must record or capture information about each unauthorized access attempt such as User ID, workstation, date and time.

6. The UPDR must have the ability to encrypt data in transit as well as data at rest. Please have ready the specific encryption levels available to your system for both data in transit and data at rest.

7. CONTRACTOR must work with DTS and DHHS on retention schedules for data. DHHS will identify record series.

IV. REPORTS

A. Collaborate to create performance measures that shall be published in reports, as needed.

1. Submit performance measures on a bi-annual basis to be published in reports as needed.

2. Starting in FY23, Q3, submit performance measures on or by the due dates for quarterly invoices, to be used by the DEPARTMENT to respond to legislative requests and reports on the following schedule:

Quarter 1: July 1 – September 30, due on or by October 15 Quarter 2: October 1 – December 31, due on or by January 15 Quarter 3: January 1 – March 31, due on or by April 15 Quarter 4: April 1 – June 30, due on or by June 15

B. The CONTRACTOR shall meet with the DEPARTMENT’s data steward to complete required tasks and report progress.

V. DATA OWNERSHIP AND CUSTODIAL RESPONSIBILITY

A. The CONTRACTOR and DEPARTMENT shall treat any identifying information as confidential information. The CONTRACTOR and DEPARTMENT shall ensure that any of its employees, agents, and volunteers comply with the terms of this confidentiality provision.

B. The CONTRACTOR shall ensure that data is collected, managed and stored by BMIC using the REDcap data management system.

C. The CONTRACTOR shall ensure that all computers on which the data reside will be located in a secure locked room with controlled access.

D. The CONTRACTOR shall ensure that all monthly backup tapes are stored off site in a secure repository.

E. The CONTRACTOR shall comply with the DEPARTMENT’s Data Stewardship Policy and Data Sharing Policy. Any research conducted with the data are subject to review and approval by the CONTRACTOR’s and the DEPARTMENT’s institutional review boards.

F. The CONTRACTOR shall securely store and protect the data and monitor who has access to it.

1. The CONTRACTOR shall ensure that access to UPDR data occurs via an encrypted secure socket layer (SSL) connection.

G. The CONTRACTOR shall provide a copy of any publication, which is based on, or relates to, the analyses performed on the data or the project evaluation to the DEPARTMENT data steward prior to release.

VI. DEPARTMENT RESPONSIBILITIES

The DEPARTMENT agrees to:

A. Participate on the Utah Parkinson’s Disease Registry Advisory Committee (UPDRAC).

B. Provide UPDR assigned staff including but not limited to the following:

1. Epidemiologist (10% FTE) - This position is responsible for activities related to

Parkinson’s Disease surveillance systems, data analysis, and reporting necessary to assess and monitor the burden of PD in Utah.

2. Program Coordinator (10% FTE) - responsible for developing strategic partnerships to increase program capacity, and advocates for the inclusion of older adults and adults with disabilities among internal and external stakeholders’ projects.

3. Program Manager (5% FTE) - responsible for overall administration of both state and federal funding sources.

4. Administrative and Finance support (2% FTE) - will address HAP’s day-to-day administrative needs, including coordinating travel documents, contractual and invoice warrants, ordering supplies and materials, mailing documents to partners, advising on DHHS policies as needed. Also, monitors all program expenditures and coordinates between the program manager and the Office of Fiscal Operations.

C. Increase awareness of the R384-300 reporting rule and enrollment in the UPDR

1. Assist CONTRACTOR with outreach materials and a plan on how to best increase awareness of among healthcare providers.

2. Assist CONTRACTOR with outreach materials and a plan on how to best increase awareness targeting healthcare providers in rural areas.

D. Surveillance

1. Present and request inclusion of PD related questions on the Behavioral Risk

Factor Surveillance System (BRFSS).

2. Annually update BRFSS measures on IBIS and DEPARTMENT website.

3. Provide data reports and presentations to the DEPARTMENT and partners as needed and per request.

4. Provide ongoing surveillance and evaluation support to partners as needed.

5. Collaborate with CONTRACTOR on 1-2 strategic evaluation plans annually.

6. Select and report performance measures to state legislators and partners as requested.

E. Reviews

1. The DEPARTMENT agrees to communicate with the CONTRACTOR on an ongoing basis to express needs related to contract services.

2. The DEPARTMENT agrees to review the services and approve the work completed prior to paying the CONTRACTOR.

3. The DEPARTMENT agrees to provide two site visits during the reporting period to ensure that progress towards meeting the terms of the Contract are completed.

4. The DEPARTMENT shall schedule meetings with the CONTRACTOR on a quarterly basis to address needs related to contract services.

VII. CONSULTATION

A. The DEPARTMENT agrees to consult with the CONTRACTOR as needed.

B. The CONTRACTOR agrees to meet with the DEPARTMENT as needed.

C. If CONTRACTOR has issues or concerns with the contract, the CONTRACTOR shall contact the DEPARTMENT for resolution.

D. If DEPARTMENT has issues or concerns with the contract, the DEPARTMENT shall contact the CONTRACTOR for resolution.