RFQ75D30120Q71863 - SOW.pdf

CKD SOW 30 April 2020

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STATEMENT OF WORK

Title: Chronic Kidney Disease Epidemiology in the Military Health System

1. Background and Need:

Chronic Kidney Disease (CKD) is a serious and growing problem—the 9th leading cause of death in the United States. The economic burden of CKD is significant: along with diabetes and congestive heart failure, it is one of the top three diseases associated with Medicare expenditures. Costs for over-65 patients with CKD have increased from 4.2% of the total

Medicare budget in 1995 to 20.1% in 2013. The yearly per-patient Medicare cost for CKD is

$21,909/patient, compare to $7931 for a patient without CKD, diabetes, or congestive heart failure. Congress has recognized the burden of kidney disease, and since 2003 specific directives for CKD were given in the Departments of Labor, Health and Human Services, and

Education (L/HHS/Ed) and Related Agencies Appropriation Bill (CKD Authorizing Legislation:

PHSA §§ 301, 307, 310, 311, 317, 317H, 399V-3 and the Patient Protection and Affordable

Care Act of 2010, § 4201 (P.L. 111-148). The Senate Committee continues to assign high priority to the CKD program, with particular emphasis on early detection to improve health outcomes and reduce the economic burden caused by dialysis and kidney transplantation.

As documented in “Advancing American Kidney Health”, a goal of the Department of Health and Human Services is to reduce the risk of kidney failure through public health surveillance capabilities and research to improve identification of populations at risk and those in early stages of kidney disease (https://www.hhs.gov/about/news/2019/07/10/hhs-launches-president-trump-advancing-american-kidney-health-initiative.html). Specifically mentioned is the collaboration between the Centers for Disease Control and Prevention (CDC) and

Uniformed Services University of the Health Sciences (USUHS) in describing the epidemiology of kidney disease in the Military Health System (MHS). This collaboration examines both active-duty and non-active-duty populations with results that have applications which are both military-specific and applicable to the US population as a whole.

The Department of Defense (DoD) Military Health System (MHS) serves 9.4 million beneficiaries including active duty service members, retirees, and their dependents. The MHS consists of both direct care in Military Treatment Facilities (MTFs) and purchased care in civilian facilities, which combined account for 979,600 admissions, 104 million outpatient

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encounters, and 116 million prescriptions (https://health.mil/I-Am-A/Media/Media-

Center/Patient-Care-Numbers-for-the-MHS). If the MHS enrollment was a Health Maintenance

Organization, it would rank as one of the largest in the U.S. with a $50 billion annual budget.

The MHS Data Repository (MDR) is the clinical and claims database for the MHS electronic health record and is a unique resource which can be used to assess the performance of the

MHS in achieving the Healthy People 2020 public health objectives

(https://www.cdc.gov/nchs/healthy_people/hp2020.htm) in comparison to other single-payer health databases which the CDC is using (e.g., Veterans Health Administration, Medicare).

This project provides ongoing access to and evaluation of important public health surveillance data from the DoD electronic health records system, critical to the U.S. CKD policy efforts. It also allows for comparison of DoD CKD metrics to Healthy People 2020 CKD indicators and goals and for delineation of specific objectives which will require advanced surveillance capabilities to track progress. This will be the only mechanism providing systemic analysis of this extremely valuable aggregated data. The project will enable (1) the clinical leadership of the MHS to understand natural history trends and outcome factors in the incidence and prevalence of kidney injury and disease in the DoD beneficiary population, and (2) the scientific staff of the Centers for Disease Control and Prevention (CDC) to strengthen their

CKD surveillance, epidemiology, economic, and health outcomes and policy initiatives

2. Project Objective:

The purpose of this agreement is to establish and support an analytical database that will assess the epidemiology, economic impact, and effectiveness of care of CKD in the MHS and contribute to the understanding of the impact of CKD in the United States.

3. Scope of Work:

1. Conduct descriptive analyses of the prevalence and incidence of CKD and end-stage renal disease (ESRD) in MHS patients, including assessment of the important epidemiological associations among active-duty and non-active duty populations.

a. Assess risk factors for the development of CKD in MHS patients to determine how they differ between active-duty and non-active-duty patients and the general population.

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b. Assess the economic impact and effectiveness of care for CKD in the MHS.

2. Conduct descriptive analyses of trajectories toward ESRD using serial creatinine measurements prior to onset of ESRD from the MHS.

a. Assess patient characteristics and risk factors for the development of ESRD in

MHS patients.

3. Explore rates of kidney transplants in patients in the MHS and how transplant survival compares to non-MHS recipients.

4. Technical Requirements

a. CDC

1) Provide funding under the Contract to HJF to cover (i) salary for Data Analyst(s); (ii) travel and education for Data Analyst(s); and (iii) purchases to be made by The Henry

M. Jackson Foundation for project-related equipment and supplies (computers and software/hardware accessories) costs.

2) Provide funding to DoD/USUHS for project-related travel and accommodation through a separate Inter-Agency Agreement (IAA) with DoD/USUHS.

3) Participate in committee activities related to assessing the CKD epidemiology, economic and health outcomes among active-duty and non-active duty populations.

4) Disseminate findings on CDC’s CKD Surveillance Project website.

5) Provide advice and consultation as needed for analysis, manuscripts, or presentations of data from the project.

b. HJF

1) Establish a Data Sharing Agreement with DoD/USUHS to enable access to MDR data for the project.

2) Provide Data Analyst(s) to

a. Collect and analyze data from the Military Health System assessing the epidemiology, economic impact, and effectiveness of care for chronic kidney disease.

b. Assist DoD/USUHS investigators with the development of presentations and manuscripts for peer-reviewed journals.

c. Create aggregate data files suitable for dissemination on the CDC CKD

Surveillance website.

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c. USUHS

1) Process project-related travel requests for DoD investigators in keeping with the funding and terms provided in the separate IAA with CDC.

2) Facilitate access and training to HJF for the clinical IT systems of the MHS.

5. Government furnished materials:

CDC will provide, where appropriate, analytic codes to assist in variable construction and definition.

6. Period of performance: August 01, 2020 through July 31, 2021.

7. Reporting Schedule (and deliverables):

7.1 Annual Technical Progress Reports shall be sent to CDC Project Officer, Dr. Meda Pavkov, with a copy to the CDC and HJF Contract Administrators.

Deliverables Due By Deliver To

Annual Technical Progress Report Within thirty (30) days after

Contract anniversary date

CDC Project Officer

CDC Contract Administrator

HJF Contract Administrator

Data updates for CDC Surveillance

Project website

March 1, 2021 CDC Project Officer

Published manuscript June 1, 2021 CDC Project Officer

C.8 Special Considerations:

HHSAR Provision, 352.239-73: Electronic and Information Technology Accessibility Notice

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

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(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508.

The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/sec508/standards.htm.

(c) The Section 508 accessibility standards applicable to this contract are: 1194.

205 WCAG 2.0 Level A & AA Success Criteria 302 Functional Performance Criteria 502 Inoperability with Assistive Technology 504 Authoring Tools 602 Support Documentation 603 Support Services

In order to facilitate the Government's determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and documentation detail - whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues.

Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS Web site http://hhs.gov/web/508.

In order to facilitate the Government's determination whether proposed EIT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If a offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(e) Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

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C.9 Government Furnished Property: None

C.10 References: None