Sources Sought.docx

SMALL BUSINESS SOURCES SOUGHT NOTICE (75N94023R00015)

Agency: The National Institutes of Health, National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK)

Title: The United States Renal Data System (USRDS) Support Services

NOTE: This is NOT a solicitation for proposals, proposal abstracts, or quotations. There is no solicitation available at this time.

This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice.

Background:

The mission of the National Institutes of Health (NIH) is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.

The mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is to conduct and support medical research and research training and to disseminate science-based information on diabetes and other endocrine and metabolic diseases; digestive diseases, nutritional disorders, and obesity; and kidney, urologic, and hematologic diseases and to improve people’s health and quality of life.

Division of Kidney, Urologic & Hematologic Diseases NIDDK's Division of Kidney, Urologic, and Hematologic (KUH) Diseases supports basic research in normal kidney function and the diseases that impair normal function at the cellular and molecular levels, including diabetes, high blood pressure, glomerulonephritis, and polycystic kidney disease. KUH provides research funding and support for basic, translational, and clinical research studies of the kidney, urinary tract, and disorders of the blood and blood-forming organs.

End stage renal disease (ESRD) is a major public health problem causing significant morbidity and mortality in the United States as well as other countries and leading to enormous financial and personal costs. Over the past 15 years, studies using the USRDS database have shown that, while the incidence rate of ESRD has stabilized, the number of new patients continued to increase due to population growth and aging. Mortality from ESRD exceeds 20 percent per year. Other studies have found that certain racial/ethnic groups, especially Blacks, Native Americans and Hispanics, are disproportionately represented in the ESRD patient population, and seem to be particularly vulnerable to certain diseases such as diabetes mellitus and hypertension that ultimately lead to chronic kidney disease (CKD) and ESRD.

The United States Renal Data System (USRDS) was created in May 1989 to collect, analyze and distribute information on the incidence, prevalence, morbidity, and mortality of CKD and ESRD population in the United States, including treatments and outcomes. The USRDS is funded directly by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The USRDS Coordinating Center (CC) staff collaborate with members of the Centers for Medicare & Medicaid Services (CMS), the Organ Procurement and Transplant Network (OPTN), and the ESRD healthcare networks, sharing datasets and actively working to improve the accuracy of ESRD patient information.

The USRDS has been in effect for over 30 years. At the start of the USRDS project computer technology was much less developed than is the case currently. For example, the CMS 2728 was usually filled out by hand and then keyed in by Network staff and forwarded to CMS (then HCFA). The process of submitting this, and other data from forms is now automated through systems formerly known as CROWNWEB, now End Stage Renal Disease Quality Reporting System (EQRS, for example Medical Evidence 2728 Forms are to be submitted in EQRS: https://eqrs.cms.gov/), and there is very little delay between submission of the forms and potential access by CMS and the USRDS. The CMS 2728 form still must be submitted to the Social Security Administration for Medicare benefits to be established.

Similarly, provider billing for parts A and B of Medicare used to go through carriers and intermediaries and there were significant delays between service dates and updates to the CMS billing archives. Consequently, data were not made available to the USRDS CC until 6 to 9 months after the end of a calendar year. The data were then used to perform analyses for the following year’s ADR. For example, the 2022 ADR, released in November of 2022 has data complete through 2020, nearly two years after the events described in the ADR.

Part of this delay is due to the implicit requirement that all chapters have complete data through the same time period. Because billing data is usually the latest to arrive that means that the timeliness of the ADR is less than it might be. For years, the CC has produced an ESRD quarterly update. These updates show that counts of incidence, prevalence and deaths are nearly complete within six months after a given quarter. However, this completeness is not used in the production of the ADR. It is expected that the next USRDS contractor will use more timely data in most, if not all, of the ADR chapters and reference tables.

Other significant changes have occurred in Medicare that haven’t been fully explored in the ADR. One is the significant increase in pre-paid managed care. In 1989, the first year of the ADR, the prevalence of managed care in Medicare was quite small and because ESRD patients were not allowed to join managed care plans, ADR analyses mostly ignored managed care beneficiaries. In 2022, fully 48 percent of all Medicare beneficiaries and 25 percent of ESRD beneficiaries belong to managed care plans (Medicare Advantage). This has been incorporated in parts of the ADR but not fully so. For example, transplantation and mortality rates could be expanded to include this growing segment of the ESRD population.

Another characteristic of Medicare coverage that has not been fully explored is dual Medicare and Medicaid entitlement/eligibility. Dual eligible beneficiaries have both Medicare and Medicaid coverage. The additional Medicaid coverage in this case is a clear indication of poverty among Medicare beneficiaries, and has not been fully exploited in ADR analytics. Access to transplantation, differential hospitalization and mortality rates as well as access to care/treatment and other indicators need to be assessed. Especially important is the potential role of this measure of poverty as a factor in explaining racial disparities in a numbers of important medical interventions and outcomes.

A major change in Medicare that hasn’t been fully explored in the ADR is part D coverage. Although most ESRD beneficiaries elect part D coverage, >10% percent do not. This is nearly 30% for CKD patients. Many of the analyses in the ADR are limited to the persons with parts A, B, and D coverage. However, persons with only part A and B coverage are often omitted from specific analyses, especially total payment and hospitalization calculations.

It is expected that the new USRDS contract will advance the timeliness of reporting and expand analyses into new patient and programmatic areas.

The USRDS has had 6 contract cycles, or phases during which it has provided the renal community (comprised of involved stakeholders including patients, providers, researchers, and members of Congress), important information on the scope of renal disease in the United States.

The United States Renal Data System (USRDS) began in 1989 through US Congressional authorization (OBRA 1986) under National Institutes of Health competitive contracting with delegation of authority with CMS, most recently updated on August 13, 2020 (https://www.federalregister.gov/documents/2020/08/13/2020-17748/delegation-of-authority). Its history includes six contract periods. Over this period, USRDS reporting transitioned from basic incidence and prevalence of ESRD, Hemodialysis (HD), peritoneal dialysis (PD), or kidney transplantation (KT) modalities, and overall survival, as well as focused special studies on dialysis, in the first two contract periods, to a comprehensive assessment of aspects of care that affect morbidity and mortality in the subsequent periods.

The first contract for the USRDS was awarded to The Urban Institute, 2100 M Street N.W., Washington, D.C. 20037. The Principal Investigator was Philip J. Held, Ph.D., and the period of performance was from May 1, 1988 through April 30, 1993. The Contract was N01-DK-8-2234 and the contract amount was $6,263,622.

The contract for the second phase of the USRDS project was awarded to the University of Michigan, Ann Arbor, Michigan. The period of performance of the contract was July 1, 1993 through November 15, 1999. The Principal Investigator was Philip J. Held, Ph.D. until February 1998, and then Robert Wolfe, Ph.D. took over as the PI for the remaining period of the contract. The total contract amount was $10,879,261.

The third phase of the USRDS project represented a change in structure for the USRDS. The work of the USRDS was decentralized and spread across five separate contracts. The contract for the CC, for data management of the data base and the production of the Annual Data Reports (ADRs), was awarded to the Minneapolis Medical Research Foundation. The Principal Investigator was Allan Collins, M.D., and the period of performance of the contract was August 11, 1999 through October 29, 2006. The total contract amount was $9,531,240.

The third phase also included four Special Studies Centers (SSCs) for the conduct and analysis of “special studies.” The Cardiovascular SSC was awarded to the Minneapolis Medical Research Foundation. The Principal Investigator was Charles Herzog, M.D., and the period of performance of the contract was August 17, 1999 through October 29, 2006 for a total contract amount of $1,581,878. The Economic SSC was awarded to the University of Iowa. The Principal Investigator was Larry Hunsicker, M.D. and the period of performance was April 10, 2000 through October 29, 2006 for a total contract amount of $1,292,371. The Quality of Life/ Rehabilitation SSC was awarded to Emory University. The Principal Investigator was Nancy Kutner, Ph.D. and the period of performance was September 18, 2001 through September 9, 2006 for a total contract amount of $1,060,636. The Nutrition SSC was awarded to the University of California at San Francisco. The Principal Investigator was Glenn Chertow, M.D. and the period of performance was October 29, 2001 through October 31, 2006 for a total contract amount of $1,850,358.

In the fourth phase of the USRDS the CC was awarded to the Minneapolis Medical Research Foundation with Dr. Alan Collins as the Principal Investigator. The period of performance was February 8, 2007 through February 7, 2014 with a total contract amount of $14,591,251. The Quality of Life/ Rehabilitation SSC was awarded to Emory University. The Principal Investigator was Nancy Kutner, Ph.D. and the period of performance was March 1, 2007 through February 28, 2014 for a total contract amount of $3,111,121. The Nutrition SSC was awarded to the University of California at San Francisco. The Principal Investigator was Kirsten Johansen, M.D. and the period of performance was July 7, 2007 through June 30, 2014 for a total contract amount of $4,045,136. The Cardiovascular SSC was awarded to the Minneapolis Medical Research Foundation. The Principal Investigator was Charles Herzog, M.D., and the period of performance of the contract was February 8, 2007 through February 7, 2014 for a total contract amount of $2,343,879. There was no Economic SSC in the fourth phase of the USRDS. All economic analyses were incorporated into the CC and Special Study Center scopes of work.

The fifth phase of the USRDS awarded the CC to the University of Michigan (Kidney Epidemiology and Cost Center, KECC), with Dr. Rajiv Saran as the Principal Investigator. The period of performance was February 8, 2014-February 7, 2019, with a total contract amount of $8,530,144. Special Study Centers were awarded as NIDDK U01 grants, with an SSC on end of life and palliative care awarded to the University of Washington, Dr. Ann O’Hare as PI. A second SCC on transitions of care was awarded to the University of California, Irvine, with Dr. Kalantar-Zadeh as Principal Investigator. The SSC participated with the CC in steering committee meetings and production of the annual data report. There were no other SSCs in this phase. The CC along with the two SSCs shed special light on the persistent problem of excessive early mortality occurring after the start of hemodialysis (with the Transitions of Care SSC examining factors pre-ESRD, and the Palliative Care SSC exploring whether alternatives to initiation of hemodialysis might be more appropriate for some patients).

The sixth phase of the USRDS awarded the CC to the Hennepin Health Research Institute (HHRI) of Minneapolis Minnesota, which contains the Chronic Disease Research Group (CDRG), with Dr. Kirsten Johansen as the Principal Investigator. The period of performance is Feb 8, 2019-March 8, 2024, with a total contract amount of $9,540,284. A special study of transitions of care was included in the contract. The difference in this transition of care study from prior studies was following a cohort of patients with advanced CKD forward in time, in contrast to following patients who started dialysis backward in time. This phase also documented the impact of the COVID-19 pandemic on people living with CKD and ESRD, notably the substantial increase in mortality and first ever documented decrease in the prevalence of ESRD. This phase also introduced new chapters on health disparities and home dialysis.

1. SCOPE

The scope of this contract includes the requirement of the USRDS CC to make data readily available to the renal community (see section on Standard Analysis (SAF) files below), maintenance and updates of the USRDS data archives, including but not limited to the production of the Annual Data Reports (ADRs) and other specified reports, publication of original research on findings from analysis of the USRDS data, and support of research to the Renal community related to the USRDS.

2. TECHNICAL REQUIREMENTS

Independently, and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, to perform the Statement of work described below:

2.1. TASK 1. Transition Activities

Transition activities are the responsibility of both the incoming and the predecessor contractors. In the event that there is not a change in contractors, the first few months’ transition activities are moot. However, planning and preparation for future transitions are still required.

The Contractor shall ensure that the USRDS database, documentations and all related software is transitioned seamlessly between the incumbent Contractor and the new Contractor, without impacting the USRDS operations. In order to reduce the risk to the USRDS operations during transition, the Government requires the development and implementation of transition plans at the beginning, interim and final stages of the newly awarded CC contract. The transition activities are the responsibility of both the incumbent and the new contractor.

Initial Transition-in Activities:

The Contractor shall perform the following activities during the Transition-In Period of the Base period of the contract:

· Coordinate all communications and activities with the predecessor Contractor.

· Transfer (from the predecessor Contractor or the Government) and inventory all Government furnished equipment (GFE, if applicable), Government furnished material (GFM), Government provided data (GPD), and Government acquired data (GAD).

· Transfer the USRDS database from the predecessor Contractor and set-up the database at the Contractor’s facilities.

· Coordinate the transfer of all software (source code and object code) for the website, database scripts, and other USRDS software.

· Become proficient with all USRDS database systems by the end of the Transition Period, expected to be 3 months.

· Within 15 calendar days after the start of the contract, provide to the NIDDK COR a draft report on the status of transition-in activities. Provide final report incorporating input from NIDDK COR within 3 months after the start of contract. This draft report shall include preparation for a new Data Use Agreement (DUA) with CMS (this will be considered a researcher DUA since from CMS’ determination, the USRDS is a research activity), as well as Data Management Plan. Templates for these forms are available at the CMS website, please contact the COR for questions.

Interim Transition-out Activities:

The Contractor shall, from the date of award, develop and document all systems and processes to ensure that there is an archived record of actions and practices. All records and information systems shall employ systematic version control, ongoing tracking and monitoring to enhance quality and to ensure survivability.

At least two months prior to the completion date of the Base Period, the Contractor shall provide to the NIDDK COR a draft transition-out plan that details the potential close-out or transfer of all contract related tasks to the Government. This document shall be organized and catalogued in sufficient detail to support an orderly transition to ensure continuity of the USRDS and its activities. The Contractor shall work with the COR and the Contracting Officer to refine and complete this plan.

During each of the following Option Periods of the contract (should they be exercised), this transition-out plan shall be revised to reflect changes in the USRDS database, documents and software to facilitate a smooth hand-off to the Government or to any future Contractor. The revised transition plans shall be updated and provided to the NIDDK COR at least 2 months prior to the end of each Option Period.

The Final Transition Plan shall be due either 1 month after notification by CO (that the next option is not being exercised) or 2 months before the end of Option Period 4.

Final Transition-out activities:

During the last period (Base or Option) of the contract, the Contractor shall collaborate with the COR and the subsequent Contractor to coordinate the handoff of USRDS operations, database, software and all related activities. In accordance with the COR and the new Contractor, the incumbent Contractor shall provide support to meet the milestones and activities as per the COR and CO approved transition schedule.

The incumbent Contractor shall perform the transfer of all databases, data management systems, website software, all publications and documentation, and files to the government and/or subsequent Contractor. All data files and software systems shall be provided in electronic format and transferred in a secure manner that meets NIH FISMA guidelines. Given the size of the ESRD data bases (77 TB), the incumbent and new contractor shall propose a method for the efficient transmission of the data base.

The incumbent Contractor shall provide support for all transition activities until the end of the period of performance. The incumbent Contractor shall maintain full operational capacity during the transition period until the subsequent Contractor has taken full control with the approval of the COR and the CO.

Deliverables for Task 1

1. Draft report on the status of transition-in activities (see above for details), due with proposal.

2. Final report on the status of transition-in activities (see above for details), due 90 days from award date.

3. Status update on weekly conference calls as in Task 1.

4. For transition out, delivery of all data and documentation from predecessor contractor to incoming contractor three months after award date.

5. Draft Transition Plan due two months prior to the end of the Base and each option period.

6. Final Transition Plans due either one month after notification by CO that the next option is not being exercised or two months before the end of Option period 4.

7. After final transfer of all files and data, the outgoing contractor shall issue a certificate of destruction at their site to CMS and the COR.

2.2. TASK 2. Provide Logistical Support for all meetings and correspondence The USRDS shall have a Steering Committee (SC) to oversee activities of the USRDS CC. In addition, the USRDS shall have a Contract Management Board (CMB), providing subject matter expertise for each chapter in the Annual Data Report. The Contractor shall provide logistical support for the USRDS CC meetings with the Steering Committee as well as the CMB. In addition, the contractor shall be responsible for logistical support of required travel as specified below.

· The Steering committee shall be composed of 2 representatives from NIDDK plus additional ad hoc members as the COR deems appropriate, 1 or more representatives from CMS, and the PI, Co-PI(s) and Project Manager, plus ad hoc members as deemed appropriate, from the USRDS CC. The Steering Committee will conduct teleconferences twice a month regarding USRDS issues (this frequency may be modified by the NIDDK COR as necessary—attendance by CMS may be less frequent, for example once a month, as jointly agreed). The Contractor shall provide for the teleconference arrangements and shall provide written minutes of each meeting to be provided to the COR within one week after the phone calls. Recently, the SC has been meeting with several CMS members on matters of mutual interest, usually on a monthly basis. This schedule may be adjusted mutually between CMS, the CC and NIDDK SC.

· The Contractor shall schedule weekly conference calls after the initiation of the contract until transition activities are complete, expected to be 3 months.

· There shall be at least one annual face to face Steering Committee meeting and site visit by the Government COR at the CC site. The exact date of the meeting will be determined by the CC and COR closer to the time of the actual meeting. The CC shall provide logistical support for this meeting including the preparation of minutes, which shall be provided to the COR and the CO within one week after the meeting.

· The Contractor shall form a CMB of 12 standing members providing subject matter expertise for each chapter in the Annual Data Report. Panel members will have expertise in biostatistics, in renal disease representing dialysis, transplantation, epidemiology, and economics. This group shall meet at least annually as stated below. With prior approval from the CO, the CC shall pay for consulting time and travel, for members of the CMB and shall provide a pre-meeting summary including agenda, invitee roster and travel status NLT one week prior to meeting date.

· If circumstances allow (per the contractor and COR), there shall be at least one initial face to face meeting of the CMB and the NIDDK COR/steering committee with key members of the CC (PI, CO-PIs, statisticians and epidemiologists – around 5-7 personnel for budgeting purposes). This will take place at the NIH campus, with the exact date determined by CC, CMB members and COR. Subsequent meetings can be held by teleconference at the discretion of the NIDDK COR. NIDDK will arrange for the meeting room. However, the CC Contractor shall make and pay for travel arrangements (including lodging, transportation, and M&IE) for the CMB and its own staff.

· The CC shall provide other logistical support for the meeting including minutes which will be made available to the COR and the CO within one week after the meeting date.

· When applicable, the Contractor shall first consider the use of Federal facilities. Hotels, conference centers, private sector businesses or other locations should be considered as alternative locations if deemed necessary through discussions between the Contractor and the COR.

· In the event of an in-person meeting, the contractor shall provide a (staffed) booth at the annual American Society of Nephrology. Booth is standard size, staffed by 1-2 people, at the exhibition area of the meeting. The final decision on this will depend on public health circumstances and mutually agreed to by the contractor and NIDDK.

Deliverables for Task 2

8. Kickoff/Initial Teleconference summary report - Meeting will be held within two months of effective date of the awarded contract. Summary report due within one week after the meeting.

9. Agenda and Roster for SC, CMB and face to face meetings – one week prior to meeting distributed to COR, CO and all attendees.

10. Meeting Minutes – one week after meeting, distributed to COR, CO and all attendees.

11. Annual Contract Monitoring Board Teleconference Summary report- Meeting will be held annually in April (exact date to be discussed between COR and CC) of the Base Year and each Option year (if exercised). Summary report due within one week after the meeting.

12. Ad hoc Teleconference summary report- up to 3 teleconferences will be held per year as directed by the COR. Summary report due within one week after the meeting.

13. Steering Committee Meeting Status reports- Pre-meeting summary including agenda, invitee roster and travel status NLT one week prior to meeting date in September annually (exact meeting date to be discussed between COR and CC). Minutes provided within one week after meetings.

14. Yearly attendance at the annual American Society of Nephrology, dependent on the circumstances above.

2.3. TASK 3. TASK 3. Maintain and update the USRDS data archives and public-facing digital presence

The Contractor shall maintain the USRDS data archives and periodically (at least annually) update it with data upon release from CMS, National Health & Nutrition Examination Survey (NHANES), United States Census, Veterans Administration, and other data bases as defined under the contract. The Contractor shall provide all necessary computing systems (that are compliant with government specified FISMA requirements), to host, and operate, and update the USRDS data archives, the custom-developed USRDS Annual Data Report website and content management system, content for display via iframes on USRDS web pages on the NIDDK Sitecore website content management system, and related database applications. In general this would be one major update and 2-3 smaller content updates annually. Per standard contracting clause, the contractor should immediately verify steps to achieving authority to operate status (ATO) NLT 90 days after contract start, IAW standard contract clause of working with federal IT systems. This was historically included under contract ARTICLE H.19.1. INFORMATION SECURITY AND/OR PHYSICAL ACCESS SECURITY, B. Security Assessment and Authorization (SA&A)- A valid authority to operate (ATO)

At present, the USRDS data is deployed on Contractor hosted computing systems and contains over 77.5 TB (77,500 GB) of datafiles. USRDS employs Oracle and Microsoft SQL Server database systems and the Annual Data Report website is implemented using Microsoft Internet Information Services (IIS) webserver. Information about USRDS data sources is provided below.

Data obtained from CMS (through agreements between NIH and CMS) form the basis for the bulk of the USRDS data archives. For the ESRD population, the primary data comes from the CROWNWEB/EQRS data system.

· The Consolidated Renal Operations in a Web-enabled Network (CROWNWEB) is a Web-based data-collection system mandated by CMS to enable dialysis facilities to meet portions of the Conditions for Coverage for ESRD Dialysis Facilities. This data system is now known as the End Stage Renal Disease Quality Reporting System (EQRS). The CROWNWEB/EQRS system contains information on all ESRD patients, including the Medical Evidence form (CMS-2728), the death notification form (CMS-2746), and the facility survey form (CMS-2746). In addition, CROWNWEB/EQRS contains clinical modules that enable monthly tracking of important clinical indications including anemia management, dialysis adequacy, vascular access, mineral metabolism, iron, and vitamin D levels.

· Non CROWNWEB/EQRS data from CMS in the USRDS data archives include (but not limited to):

Other governmental data not obtained from CMS include:

· NATIONAL HEALTH & NUTRITION EXAMINATION SURVEY (NHANES) NHANES is a series of health examination surveys conducted by the National Center for Health Statistics (NCHS) of the Centers for Disease Control and Prevention (CDC). Begun in 1960, NHANES is designed to monitor the health and nutritional status of the noninstitutionalized civilian population in the United States. Data from NHANES are used to characterize the CKD population in the general US population

· Organ Procurement and Transplant Network (OPTN) – including waitlist information, transplant events and post-transplant follow-up. This information has historically been obtained from the United Network of Organ Sharing (UNOS) through agreement.

· United States Census – provides population estimates which are used in the calculation of incidence and prevalence rates.

Other data are also used currently by the USRDS CC but may or may not be included in the future. They will be purchased by the Government from commercial sources and provided to the USRDS CC Contractor. These data sources include:

· CDC Wonder, National Center for Health Statistics

· United States Geological Survey (USGS Files).

· National Death Index (could be as part of CMS VRDC), contact NIDDK USRDS COR for details.

Deliverables for Task 3

15. Data sources and any licenses necessary to use them on the last day of the contract.

16. All software documentation, data files, databases and reports, due 30 days prior to the last day of the contract.

17. Annual reports on the status of all data sets 60 days prior to the end of each contract period (Base and option periods 1-4)

2.4. TASK 4. Preparation of Analysis Plan for the ADR

Within two months after the award date, the Contractor shall provide the COR a detailed plan for the creation of the following year’s ADR. This plan shall include a brief description of the previous ADR chapters and a plan for updating each chapter, including the data sources used (ie Medicare FFS, Medicare Advantage, Medicaid, etc). The ADR analysis plan shall be updated annually within two months after the publication of the ADR. The analysis plan shall be submitted to the COR and CO for review and approval and work on the ADR shall not commence until COR approval is obtained.

Each year’s analysis plan shall include responses to comments received from the government COR, the Contract Monitoring Board, and others in the renal community. There should be one planning file for each proposed chapter and reference table, respectively.

If the ADR analysis plan is submitted by documents (Excel, Word, etc) the files shall be named by consecutive number and also include a brief name of the chapter the file refers to. As an example, “1 SAP CKD Ch1 Gen Pop,” “2 SAP CKD ch2 ID and care” etc, as mutually agreed between the contractor and NIDDK. These files can be shared by secure web based delivery systems as mutually agreed by the contractor and NIDDK.

As below, although no COVID specific chapter is included in contrast to recent ADR’s, plans should include COVID related information and impacts. This could include vaccinations as well as infections and associated outcomes.

Deliverables for Task 4

18. Analysis Plan for future year ADR (2 months after award date) and annually NLT two months after ADR publication. The format and response to the ADR analysis plan shall be mutually arranged between the contractor and NIDDK. The contractor may send individual plans as they are complete without waiting for the two month deadline.

2.5. TASK 5. Preparation of the ADR

Annually, the Contractor shall publish the ADR. Drafts of the ADR shall be provided to the government COR and CMB members by June 15 of each calendar year. The final ADR shall be published via the Internet by October 31 of each calendar year. The contractor shall annually maintain the content on all USRDS website pages on niddk.nih.gov domains.

· Hosting for the USRDS website pages is split between pages housed on the NIDDK-hosted Sitecore website content management system (Sitecore Web Content Management System (WCMS)) and pages and content housed and hosted by the contractor.

· Contract staff will be required to obtain NIH-issued PIV cards in order to obtain access to the Sitecore WCMS

· The pages and content hosted by the contractor include ADR pages, and Quarterly ESRD report and DESKRIBE content and data visualizations because the content is associated with and generated from the databases housing personally identifiable information (PII). All hosting approaches must be compliant with federal security standards.

· The contractor shall host the USRDS Annual Data Report website’s custom website content management system (ADR WCMS) The entire ADR shall support full text word search of its entire contents and return results by chapter (location). Previous versions of the ADR were searchable only within individual chapters.

The ADR has three parts:

· CKD/AKI chapters

· ESRD chapters

· Reference tables The CKD/AKI volume of the ADR shall include the chapters listed below:

Note: This list may be revised at the discretion of the NIDDK COR with chapters being added, deleted or otherwise reorganized. For example, based on the COVID epidemic, the COR directed the USRDS CC to conduct analyses directly relevant to that issue. Although not anticipated, any future health issue of that magnitude could result in changes to ADR requirements. Any revisions will be promptly provided by the NIDDK COR to the CC Contractor to enable timely preparation of the next year's ADR.

Of the eight analytical chapters listed below, at least five shall be published annually. The COR, with input from the steering committee, will determine which chapters will be published each year. For example, Chapter 1 is based on NHANES data. Because NHANES is updated biannually, this chapter could be updated biannually as well.

Geospatial analysis and incorporation of mapping/geographic data integrating multiple data sources is recommended where applicable, especially chapters 1, 2, 3 and 5.

The contractor shall propose uses of Artificial Intelligence/machine learning to facilitate creation of data tables and chapters.

The contractor shall indicate key areas of overlap (common topics or intersections) between chapters with links between different chapters, so users can recognize related information in different chapters.

All Figures should have font size and visibility to support exportation to PowerPoint as slides and still be legible for presentations to a mass audience, since this is a primary use of the USRDS by stakeholders.

The CKD chapters using Medicare data will incorporate, to the extent possible, distinctions in the population based on Medicare buy-in (Medicare/Medicaid dual entitlement/eligible) status. This is indicated, for example, by the variable “DUALELIG” in the Payhist file. This is particularly important for the Morbidity and Mortality, health disparities, expenditures, and prescription drug use chapters. Medicare buy-in/dual eligibility is a direct measure of poverty and should be included in future analyses to the extent possible.

Assessment of all outcomes below shall include all ages (including children, covered by separate chapters below, which will require access to non-Medicare data as above) and, for non-fatal outcomes, must include both inpatient and outpatient (also including Physician supplier/physician billing, emergency department visits) sources of information. Since use of physician supplier/physician billing files will be new for this cycle (previous cycles assessed emergency department visits as outpatient), the contractor should provide analysis for the current and previous year for the first contract year, with subsequent updates in future contract years periodically depending on the cycle of chapter and table publication as below.

Although no COVID specific chapter is planned for the current cycle, in contrast to ADR’s from 2020 on, it is expected that chapters will highlight COVID related mortality and complications as appropriate, and based on the approval of the ADR analysis plan above.

For outcomes based on claims data (ie, other than death or incidence/prevalence), whether inpatient or outpatient, standard and historically established categorizations of cardiovascular, infectious, and cancer shall be used (see prior ADR analytical methods). In addition, up to five specific conditions/diseases for the morbidity and mortality chapter or other chapters including such data will be decided by the CMB and COR, in coordination with the contractor. This could include a general new category for behavioral conditions including depression, suicidality, addition, and others. Urinary tract infections for CKD and vascular access infections for ESRD were used as examples of potential conditions of interest below.

As indicated in the background the most recent data available shall be used for presenting information in reference tables and chapters. Discrepancies can be resolved jointly by the USRDS steering committee.

· CKD in the General Population. NHANES is a cross sectional view of the US population. As such there is not follow-up data and the analyses are descriptive in nature.

· Identification and Care of Patients with CKD. This chapter and the following chapters use Medicare, Medicaid, and other administrative data bases to identify CKD patients, usually on billing data.

· Morbidity and Mortality in Patients with CKD. This chapter uses the identification of patients from chapter 2 to examine outcomes of patients with CKD. To the extent possible, morbidity should be determined using measures in addition to hospitalization. For example, urinary tract infections could also appear in physician supplier, outpatient, or emergency department claims.

· Health Disparities. This chapter focuses on racial, ethnic and sex disparities in the prevalence and outcomes related to CKI. As noted above, measures of socio-economic status, such as Medicare dual eligible should be examined as mediators explanators or predictors of health disparities

· Acute Kidney Injury/Acute Kidney Disease (including acute presentations of kidney disease). Generally, CKD is considered to be a chronic condition. However, the sub-set of kidney disease that is acute in nature is the focus of this chapter, with the understanding that AKI can lead to CKD and there can be AKI episodes within the general CKD population. Of note, this chapter should also include AKI related to cancer diagnoses and treatments, since this is expected to be a growing issue. This can include not only diagnoses related to cancer, but also use of chemotherapeutic medications from Part D files, compiling a list of medications agreed upon by the CMB and the Steering Committee. The literature provides chemotherapeutic and other medications associated with AKI.

· Health Care Expenditures for Persons with CKD and AKI (including both acute and chronic presentations of kidney disease). As with chapter 3, this chapter examines the cost outcomes associated with patients with CKD and AKI.

· Prescription Drug use in Patients with CKD. As with chapter 3, this chapter examines prescription drug use associated with patients with CKD and AKI.

· Transition of Care in Chronic Kidney Disease. This chapter specifically examines the transition of CKD into ESRD.

· CKD Analytical Methods.

The ESRD volume (2) of the ADR shall have the chapters listed below.

Note: This list may be revised at the discretion of the NIDDK COR with chapters being added or deleted. For example, based on the COVID epidemic, the COR directed the USRDS CC to conduct analyses directly relevant to that issue. Although not anticipated, any future health issue of that magnitude could result in changes to ADR requirements. Any revisions will be promptly provided by the NIDDK COR to the CC Contractor to enable timely preparation of the next year's ADR.

Geospatial analysis and incorporation of mapping/geographic data integrating multiple data sources where applicable, especially chapters 1, 4-7, and 9.

Of the twelve analytical chapters listed below, at least eight will be published annually. The COR, with input from the steering committee, will determine which chapters will be published each year.

· Incidence, prevalence, patient characteristics, and treatment modalities. This chapter is always concerned with the most recent trends in the ESRD patient population.

· Clinical indicators and preventive care, including Healthy People (HP) 2030/2040 goals. This chapter examines the treatment patterns of people with ESRD.

· Vascular Access. Both hemodialysis and peritoneal dialysis access issues are the subject of this chapter.

· Morbidity (Inpatient and Outpatient outcomes) and Mortality in Patients with ESRD. This chapter uses the identification of patients from chapter 2 to examine outcomes of patients with ESRD. To the extent possible, morbidity should be determined using measures in addition to hospitalization. For example, vascular access infections could also appear in physician supplier, outpatient, or emergency department claims. Another example would be peritonitis occurring in patients undergoing peritoneal dialysis, which is a key clinical measure. Algorithms using claims data have been published ( https://pubmed.ncbi.nlm.nih.gov/36108889/ ), and are also included in the previous USRDS ESRD analytical methods (https://usrds-adr.niddk.nih.gov/2022/end-stage-renal-disease/esrd-analytical-methods).

· Transplantation. This chapter deals with access to kidney transplantation as well as outcomes of transplantation.

· Pediatric ESRD and CKD populations. This chapter examines pediatric populations specifically. For the CKD population, data bases other than Medicare (such as Medicaid) are required.

· Home Dialysis. Trends in home dialysis incidence, prevalence, and outcomes are the subject of this chapter.

· Healthcare Expenditures for persons with ESRD. Total Medicare expenditures are the subject of this chapter, with emphases on variations by demographic, treatment, and coverage categories (including dual eligible).

· Prescription drug use in patients with ESRD. Drug use patterns are the subject of this chapter, with emphases on variations by demographic, disease, treatment, and coverage categories (including low-income supplement (LIS) coverage).

· International comparisons of ESRD.

· Healthy People 2030/2040.

· ESRD Analytical Methods Reference tables The ADR has three major components, the CKD/AKI and ESRD chapters which are more analytical and have explanatory text, and the Reference tables which provide much more detailed descriptive statistics. Each year attention has been given to the chapters but little has been done to improve the reference tables. This is especially important in that there are many different rate calculations for transplantation, hospitalization, mortality, vascular access, prescription drug use, and costs. Because of the changing populations and the differentiation of the populations by Medicaid dual eligible, managed care, and part D enrollment, it is essential that the reference tables include not only the relevant rates but tables showing the numerators and denominators used in each calculation. For example, the hospitalization reference tables currently show both numerators and denominators. Other reference tables should show similar descriptions.

Also, where appropriate, separate tables need to be calculated for subset coverage populations described above (dual eligible/ non dual eligible, managed care/non managed care, and persons with coverage for Parts A and B only and those with parts A, B and D).

Currently, the CKD reference tables only include prevalence and cost tables. The prevalence tables should include break outs for dual eligible persons and for persons with A and B only and those with A, B and D. New tables should be considered for other outcomes including mortality, hospitalization/morbidity, pre ESRD vascular access, and progression to ESRD. The cost tables should have breakouts for dual eligible/nondual eligible and for persons with and with part D coverage.

The ESRD reference tables that need to incorporate separate tables for dual eligible/ non dual eligible and persons with A and B only versus those with A, B and C include the transplant, hospitalization, mortality, survival, and cost chapters.

Currently, there are no reference tables for prescription drug use (Part D). Descriptive data on types of drug use should be developed for both CKD and ESRD populations.

Volume 1 - CKD:

B. Prevalence.

G. Inpatient and Outpatient outcomes H. Mortality K. Economic Costs of CKD.

L. Prescription Drug use

Volume 2 - ESRD:

In volume 2 – ESRD, the following reference tables shall contain both unadjusted and adjusted rates, A – incidence, B – prevalence, G – morbidity and hospitalization, H – Mortality and causes of death, and I – patient survival. The adjustment methods shall include adjustment for age, sex, race and Hispanic ethnicity.

The ADR CKD and ESRD chapters shall also include maps showing the geographical dispersion of CKD and ESRD rates and outcomes. For online versions of the ADR, the maps shall include the “hover” feature that displays the underlying statistics as viewers use the computer mouse to illustrate the data.

As part of preparation for the HP 2030/2040 chapters, the Contractor shall also provide drafts of the ODPHP objectives memos for the kidney section of HP 2040 when needed by the COR.

Deliverables for Task 5

19. Preparation of the Annual Data Report - Draft versions of the ADR should be sent to the COR and CMB by June 15 of each year. The draft report shall be subject to review and acceptance by the COR NLT 30 days after submission. Acceptance will depend on general readability, accuracy, and conformance with prior NIDDK input (which may, but does not necessarily coincide with CMB input). Final publication of the annual data report website, shall be done by October 31 of each year in a manner that is Section 508-compliant and compliant with the 21st Century Integrated Digital Experience Act and NIDDK website governance and style guides. Related updates will be made as needed to the content in DESCRIBE and on the NIDDK Sitecore website content management system and shall be completed within five business days after the ARD publishes.

2.6. TASK 6. ESRD Quarterly Update tables

For years, the CC has produced an ESRD quarterly update. These updates show that counts of incidence, prevalence and deaths are nearly complete within six months after a given quarter. However, this completeness is not used to make informed estimates of projected final counts of these important outcomes. Such projections would change as new data arrive, but the renal community would benefit from informed estimates of population dynamics that are closer to real time events. The Contractor will suggest a method of using the quarterly data to make projections of expected ESRD incidence, prevalence and deaths in the US ESRD population. It is expected that these projections will be updated on a quarterly basis.

Deliverables for Task 6

20. Thirty days after each quarterly receipt of ESRD population updates (new cases, deaths, transplants, etc) year to date cumulative summaries by demographic groupings will be published on the USRDS web page on…