Utilization of Data Indicators in the ESRD Survey Process

The Centers for Medicare & Medicaid Services (CMS) intends to issue, on a sole source basis, a solicitation to the University of Michigan/Kidney Epidemiology and Cost Center (UM/KECC), for the purchase of services of the contractor who has the infrastructure in place to produce and support a series of data reports for End Stage Renal Disease (ESRD) dialysis facilities, Transplant Programs, and Organ Procurement Organizations (OPO) used by surveyors, State Agencies, Regional Offices, and Central Office in their oversight responsibilities for ESRD dialysis facilities, Transplant Programs, and Organ Procurement Organizations. These reports include facility-specific Dialysis Facility Reports, center-specific Transplant Program Reports, organization-specific Organ Procurement Organization Reports, State-specific reports, Regional-specific reports, and State-specific rank-ordered Outcome Lists. In addition, this contract will include developmental, implementation, data research, and data integration work related to CMS' automated ESRD survey process, using PC Tablet technology. The University of Michigan/Kidney Epidemiology and Cost Center (UM/KECC) has an infrastructure in place that will support the rapid development and distribution of these various data reports. They are well recognized as a national contractor with highly-developed technical and clinical ESRD/Transplant/OPO expertise in areas of ESRD/Transplant/OPO risk-adjustment modeling, statistical management, and evidence-based comparative data reporting. They have a national reputation for fairness and no conflicts-of-interest with their work. They are also able to successfully defend their modeling and analysis to the Congress, the public and the Medicare provider community. They understand the ESRD/Transplant/OPO health delivery system, the survey and certification process for these providers, the use of data in this survey process, the criteria required for user-friendly survey reports and the ESRD/Transplant/OPO and CMS information environment in order to accomplish this task in an effective and efficient manner. The University of Michigan/Kidney Epidemiology and Cost Center (UM/KECC) has unique qualifications for this job. UM/KECC has the experience and infrastructure in place to rapidly produce data reports for the ESRD and transplant community. Prior to producing Dialysis Facility Reports for ESRD Survey and Certification, UM/KECC contracted in 1986 to initiate the United States Renal Data System (USRDS), the first national compendium of renal data. Since, 2013 UM/KECC has once again been the primary contractor with NIH for the USRDS contract. Furthermore, UM/KECC is the primary contractor with CMS for development and maintenance of ESRD Quality Measures under a Measure and Instrument Development(MIDS) IDIQ task order , is the primary contractor on the CMS Prospective Payment System (PPS), is the technical/clinical content subcontractor on the Center for Medicare and Medicaid Innovation (CMMI/CMS) contract charged with evaluation of the CECI Demonstration Project evaluating effects of the End Stage Renal Disease Seamless Care Organization on cost and quality of care for US chronic dialysis patients and is a subcontractor for the ESRD Quality Incentive Program (QIP) task under the MIDS tasks order . UM/KECC has continued to work with other contractors on the utilization of data from CROWNWeb in quality reporting and oversight for CMS' ESRD Program. Given the major role for the contractor in support of the Medicare ESRD Program S&C oversight of US ESRD providers, the contractor must be able to demonstrate that they can successfully avoid and/or mitigate real or perceived organizational and individual employee conflicts of interest. In particular, business relationships with ESRD providers is of particular concern, given the close supporting role of the contractor and contract deliverables with the survey/oversight process. UM/KECC has successfully avoided both perceived and real conflicts of interest by avoidance of research and business relationships with dialysis provider organizations, pharmaceutical and medical equipment manufacturing businesses. In the performance of its current contract with CMS S&C, UM/KECC has demonstrated detailed knowledge of the Surveyor Training Assistant Renal (STAR) computer software and the ability to apply clinical and software development expertise to STAR development activities. In addition, UM/KECC has demonstrated clinical and technical expertise and the specific ability to effectively contribute this expertise in support of ongoing educational programs developed and implemented by CMS related to ESRD facility survey and certification oversight. UM/KECC is nationally known for its work in ESRD/Transplant/OPO risk-adjusted modeling, statistical management of data, evidence-based research, and sound reporting of comparative data. UM/KECC personnel present at national meetings, publish in national journals, and sit on national expert panels as technical and clinical experts. Through the years, UM/KECC has been the major contractor for CMS for ESRD facility-specific data reports. A review of the professional literature, professional meeting presentations, Technical Expert Panel memberships, and current data reports shows that UM/KECC is the only company with the infrastructure in place and required national reputation for technically-sophisticated and unbiased reporting of data for highly-sensitive risk-adjusted and comparative reports. Currently, UM/KECC holds contracts with CMS to produce the following ESRD facility-specific databases and reports: Dialysis Facility Reports, Outcomes List, Dialysis Facility Compare outcomes measures, and Clinical Performance Measures Report. Performance under these contracts has been deemed successful. THIS IS NOT A REQUEST FOR PROPOSAL. The Government will not evaluate proposal responses or accept phone calls in response to this notice. All responsible sources may submit capability statements in consideration to the Agency at the above address. Foremost among the criteria necessary for this contract is the mandate that the contractor be nationally recognized for technical accuracy and integrity in the specialized field of producing ESRD comparative, risk-adjusted facility-level reports. This pre-solicitation notice is hereby posted in accordance with FAR 5.2. CMS reserves the right and anticipates making a single contract award. The solicitation will be issued in accordance with FAR Part 15. CMS plans to issue the solicitation on a sole source basis. This justification is based upon the authority of 41 U.S.C. - 253(c)(1) as implemented by FAR 6.302-1(a)(2), that only one responsible source, and no other supplies or services, will satisfy the agency's requirements.