UMKECC Oversights SS (210788).pdf

Utilization of Data Indicators in the End Stage Renal Disease (ESRD), Transplant, and Organ Procurement Organization (OPO) Programs

Pre-solicitation/Sources Sought Notice: 210788

Centers for Medicare and Medicaid Centers for Clinical Standards and Quality Clinical Standards Group (CCSQ)

This notice serves as both a pre-solicitation notice and sources sought notice.

PRE-SOLICIATION NOTICE IN ACCORDANCE WITH FAR 5.2: 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 (OPOs) used by surveyors, State Agencies, Central Office and the other CMS locations in their oversight responsibilities for ESRD dialysis facilities, Transplant Programs, and Organ Procurement Organizations. These reports include facility-specific Dialysis Facility Reports, program-specific Transplant Program Reports, organization-specific Organ Procurement Organization Reports, State-specific reports, Regional-specific reports, and State-specific rank-ordered Outcome Lists.

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, transplant and OPO communities. 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. 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.

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 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.

SOURCES SOUGHT:

Although as sole source award is anticipated, CMS is interested in determining if there is more than one responsible source. As such, CMS would like to obtain information regarding the availability and capability of qualified contractors who have the capacity to provide CMS with detailed data reports about End Stage Renal Disease (ESRD) dialysis facilities, Transplant Programs, and Organ Procurement Organizations in formats that are useful to CMS, States, health care providers, and the public. These reports will include summaries of patient characteristics, facility characteristics, patient outcomes, and facility practice patterns. These reports will include comparative State, Network, Regional, and National statistics as appropriate. These reports will be the basis for administering these quality, safety and oversight survey activities within the Centers for Medicare and Medicaid Services (CMS). The contract will be procured under the following NAICS: 541720 Research and Development in the Social Sciences and Humanities. This information will assist CMS in determining if there is only one responsible source and no other supplies or services will satisfy agency requirements per

FAR 6.302-1.

This is NOT a solicitation for proposals, proposal abstracts, or quotations. This notice does not commit the Centers for Medicare & Medicaid Services (CMS) to award a contract in the future.

The Government will not evaluate proposal responses or accept phone calls in response to this notice.

The Government does not intend to award a contract on the basis of this notice or otherwise pay for any information solicited. Responses to the information requested will assist the Government in determining the appropriate acquisition method.

CAPABILITY STATEMENT INFORMATION

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. Please prepare a capability statement addressing your company’s knowledge, expertise and experience, within the last three (3) years, for each of the following requirements (1) through (3) listed below. The vendor shall provide enough information for CMS to make a determination as to the capability to perform the same or similar size and scope of work.

Capability statements shall be limited to 5 pages and fonts no smaller than 12 points.

1) As it relates to the Requirements Overview, demonstrate your expertise and experience in collecting, evaluating and utilizing all ESRD data to develop and distribute Dialysis Facility Reports (DFRs) which are risk-adjusted and facility-specific, State-specific, Regional-specific and corporate-specific. Discuss how this exertise and experience is relevant to the following Requirements Overview:

Requirement Overview: Data from all available sources, including claims forms, eligibility forms, clinical data sources, facility inventories, death forms, and survey and certification forms will be updated, edited, and utilized to create a series of reports that will assist CMS, States, and other entities in monitoring the care in the ESRD facilities specific for the fiscal year, and will include a rank-ordered Outcomes List of ESRD facilities for each State and a reversed version of said lists (i.e. top performing facilities) for public access. The Outcomes Lists will be constructed from a composite of data elements that most validly and reliably identify facilities with potential problems.

During the contract period, the contractor will undertake an iterative revision of the

DFRs. The goals of this revision include 1) better intrinsic alignment with the ESRD Core Survey process, 2) development of data sources and data tools to allow State Surveyors convenient and timely access to more current dialysis facility quality outcomes, and 3) use of State Surveyor and other DFR user focus groups at pre-specified times during the contract to seek feedback and suggestions from the primary users of the DFRs about additional revisions that should be considered.

The project will provide guidance on using advanced technologies and integrating all available data sources into the data reports, and incorporate plans to integrate emerging technologies for future years, such as the emerging technologies associated with Electronic Health Records (EHRs).

2) Demonstrate your expertise and experience in providing data reports and technical assistance for Transplant Programs that follow the requirements stipulated in the Transplant Conditons of Particpiation. Discuss how this expertise and experience is relevant to the following requirements overview:

Requirement Overview: The contract will provide CMS the technical data needed to oversee the safety, quality and performance of transplant programs through surveillance and certification. Obtain and analyze monthly data as well as Program- Specific Report statistics, data, and documentation to create initial transplant reports, periodic reports on volume, outcomes aextended outcomes reports. The report will provide counts of transplant procedures, deaths, and graft failures; describe the time frame for the deaths and graft failures; and provide an interim estimate of the SMR by 6-month periods.

3) Demonstrate your expertise and experience in data reports and technical assistance for

Organ Procurement Organizations (OPOs). Discuss how this expertise and experience is relevant to the following requiremetns overview:

Requirements Overview: The contractor shall produce annual performance reports based on the two new measures established in the Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organizations, published in the Federal Register December 2, 2020, at 42 CFR 418.318(d). The reports will include a review of the donation rate (calculated as the number of donors in the DSA as a percentage of the donor potential.) and the transplantation rate (calculated as the number of organs transplanted from donors in the DSA as a percentage of the donor potential. The organ transplantation rate is adjusted for the average age of the donor potential.

The contractor will also produce additional reports that are required for the operation and implementation of the OPO program on an as-needed basis. The contractor will work with CMS to determine the data to be utilized and the statistical calculations.

References

Include the following information for each reference utilized to demonstrate experiences and capabilities:

• Name of Contracting Activity

• Contract Number, If Applicable

• Period of Performance

• Total Contract Value

• Contracting Officer, Telephone Number and Email Address, as applicable

• Contract Program Manager, Telephone Number and Email Address, as applicable

Note: Please include non-governmental contracts that are applicable.

ADDITIONAL INFORMATION REQUESTED:

Interested parties having the capabilities necessary to perform this requirement may submit capability statements in PDF format via email to Jean Sillon (jean.sillon@cms.hhs.gov) and Brian Humes (brian.humes@cms.hhs.gov).

CAPABILITY STATEMENTS MUST DEMONSTRATE THE MINIMUM REQUIREMENTS OUTLINED

ABOVE. Please address each in order listed above under “Capability Statement Information.”

Capability statements shall also include the following in a cover page:

Business Information --

a. DUNS

b. Tax ID

c. Company Name

d. Company Address

e. Business Size Status must be validated via the System for Award Management

(SAM) for the applicable NAICS 541720 Research and Development in the Social Sciences and Humanities. All vendors must be registered in the SAM located at http://www.sam.gov.

Responses must be submitted by 3:00 PM EST, Monday, February 22, 2021. Capability statements will not be returned and will not be accepted after the due date.

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to mailto:jean.sillon@cms.hhs.gov http://www.sam.gov/ perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted.

Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

Conflicts of Interest. It is essential that the vendor be free of all appearance of or actual conflicts of interest. Specifically, the vendor must not have any relationships or arrangements through its business operations or its employees that could be considered as possibly lessening the company’s objectivity concerning any aspect of the campaign. If such relationships or arrangements exist, vendors shall be required, during the procurement process, to identify potential conflicts of interest and discuss how the conflicts will be addressed and mitigated.

Protection of Privileged or Confidential Commercial or Financial Information The Freedom of Information Act (FOIA), 5 U.S.C. § 552, provides individuals with a right to access certain records in the possession of the Federal government, subject to certain exemptions. Exemption 4 of the FOIA permits information to be withheld that is in the nature of "trade secrets and commercial or financial information obtained from a person and privileged or confidential." The term "person" refers to a wide range of entities, including corporations, banks, state governments, agencies of foreign governments, and Native American tribes or nations, who provide information to the government. Information that does not qualify withholding under the Exemption will be disclosed.

CMS may invoke Executive Order 12600 in accordance with FOIA Regulation 45 C.F.R. § 5.42.

Information provided by entities to CMS in response to this notice may be subject to FOIA disclosure requirements unless protected under Exemption 4 of the Freedom of Information Act. Should entities wish to protect any trade secret or confidential information under Exemption 4, they should mark their submission accordingly citing applicable redactions and non-disclosure rationale. Pre-disclosure redactions and non-disclosure rationale shall be sent via e-mail to the requesting contracting officer with a copy to the CMS FOIA Office at 12600@cms.hhs.gov.

If an entity’s submission is not marked and CMS receives a FOIA request related to this notice, the CMS Contracting Officer will notify the the entity. The entity will have 10 working days to object to the release of any part of their information submitted to CMS citing relevant case law.

Final determination on the applicability of Exemption 4 of the FOIA are made on a case-by-case basis by CMS.

The statutory language of the FOIA is codified at 5 U.S.C. § 552(b). Additional information and resources, including the 9 FOIA Exemptions and HHS FOIA Regulation, and examples, can be found on the HHS FOIA Website.

mailto:12600@cms.hhs.gov

Questions concerning submission requirements may be directed to Jean Sillon, Contract Specialist, via email at jean.sillon@cms.hhs.gov .

On behalf of the Centers for Medicare & Medicaid Services, thank you for your interest in this project.

mailto:jean.sillon@cms.hhs.gov