Synopsis (Pre-Solicitation_Notice).docx

Pre-Solicitation Notice – Sole Source Synopsis Data Analysis for the Quality, Safety & Oversight of the End Stage Renal Disease (ESRD), Transplant, and Organ Procurement Organization (OPO) Programs | June 9, 2026

PRE-SOLICITATION NOTICE

In Accordance with FAR Subpart 5.2

The Centers for Medicare & Medicaid Services (CMS) intends to award a sole source, firm-fixed-price contract to the University of Michigan / Kidney Epidemiology and Cost Center (UM/KECC) for data analysis and reporting services in support of the quality, safety, and oversight of the End-Stage Renal Disease (ESRD), Transplant, and Organ Procurement Organization (OPO) programs. This action is being taken on a sole source basis pursuant to FAR 6.302-1(a)(2) and 41 U.S.C. § 3304(a)(1), as only one responsible source exists and no other supplies or services will satisfy the agency's requirements.

DESCRIPTION OF REQUIREMENT

CMS requires the contractor produce detailed data reports on End-Stage Renal Disease (ESRD) dialysis facilities, Transplant Programs, and Organ Procurement Organizations (OPOs) in formats useful to CMS, States, healthcare providers, and the general public. The reports will include summaries of patient and facility characteristics, patient outcomes, facility practice patterns, and comparative State, Network, Regional, and National statistics. These reports serve as the foundation for CMS's oversight of the quality and safety of ESRD, Transplant, and OPO programs.

The contractor shall produce and distribute the following reports and analytical products:

Facility-specific Dialysis Facility Reports (DFRs) Initial Transplant Program Reports (monthly) Transplant Composite Reports for survey scheduling Organization-specific Organ Procurement Organization (OPO) Reports State-specific and Regional-specific reports State-specific rank-ordered Outcomes Lists, including reversed top-performer versions for public access All reports shall be posted to a secure website and distributed in a timely manner to support CMS surveyors, State Agencies, and other oversight stakeholders. This requirement is non-commercial in nature, as it cannot be readily procured through the commercial marketplace without substantial modification to commercial specifications.

BASIS FOR SOLE SOURCE DETERMINATION

CMS has determined that UM/KECC is the only responsible source capable of fulfilling this requirement based on the following unique qualifications:

Established CDR Infrastructure — UM/KECC has maintained direct integration with the CMS Central Data Repository (CDR) System since 2023, supported by an active Data Use Agreement (DUA). Replicating this infrastructure would require significant time for security clearances, technical integration, and DUA negotiations.

Validated Risk-Adjustment Models — UM/KECC has developed and continuously refined ESRD-specific risk-adjustment models over decades. Developing and validating comparable models would require years of effort and substantial research investment.

Specialized Expertise — UM/KECC employs personnel with rare, dual clinical and statistical expertise spanning nephrology, transplantation, organ procurement, biostatistics, and health informatics.

National Reputation for Impartiality — As an academic research center, UM/KECC operates independently from commercial dialysis organizations, transplant programs, and OPOs, ensuring objective and unbiased analysis. UM/KECC has successfully defended its methodologies before Congressional committees, the Medicare provider community, and the general public.

Institutional Knowledge — UM/KECC has produced ESRD/Transplant/OPO reports for CMS continuously since the 1990s, accumulating over 25 years of institutional knowledge essential to CMS's regulatory mission.

A determination by the Government not to compete this action is solely within the discretion of the Government.

CMS reserves the right to make a single contract award.

MARKET RESEARCH RESULTS

A Sources Sought Notice (No. 260109J) was posted to SAM.gov on May 12, 2025. Seventeen (17) responses were received — 7 from small businesses, 9 from large businesses, and 1 from a business of unknown size. Upon evaluation against all three required capability areas, no respondent was deemed capable of performing the required work.

SOLICITATION INFORMATION

A formal solicitation package will be available on or about June 10, 2026, and will be issued in accordance with FAR Part 15. Questions regarding this notice should be directed to:

Joshua Czerski — Joshua.czerski@cms.hhs.gov Brian Humes — brian.humes@cms.hhs.gov

ADDITIONAL INFORMATION

1. NAICS and PSC Classification Codes (Required per FAR 5.207(a)(1))

2. ESTIMATED CONTRACT VALUE

(Required per FAR 5.207(a)(16))

3. RESPONSE DEADLINE

(Required per FAR 5.301 — Interested parties must be given at least 15 calendar days to respond)

4. POINTS OF CONTACT — PHONE NUMBERS

(Required per FAR 5.207(a)(17))

5. CONTRACTING OFFICE NAME AND ADDRESS

(Required per FAR 5.207(a)(3))

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