J-and-A-Other-Than-Full-and-Open.pdf

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

Completion Instructions: The Department of Health and Human Services (HHS) has established a standard template for the preparation of a J&A for Other Than Full and Open Competition. If this is an 8(a) set-aside, please note this form is not required unless the acquisition is valued (including all options) at greater than $22 million. This template is NOT applicable for actions using simplified acquisition procedures (FAR Part 13), Federal Supply Schedule orders (FAR 8.4) or task or delivery orders subject to fair opportunity (FAR 16.505).

Tailor all aspects of this template to the individual acquisition. Consult FAR Subpart 6.3 for guidance. An addendum may be added in case additional space is needed.

When this document is printed, the blue italic instructions are automatically deleted on the printed version.

Acquisition Title:

Agency:

Acquisition Year (FY):

Author and Title:

2. Description of Action:

Nature: New Requirement Follow-on Requirement

Modification to Existing Purchase Order/Contract Number:

Pricing: Firm-Fixed Price Time & Materials Cost

Other:

Funds: OMA Other Funds:

Name of Proposed Contractor(s):

Street Address:

City, State, Zip:

3. Description of Services or Supplies:

Basis for Approval (FAR 6.303-1(d)): Individual Basis Class Basis

The total estimated value of the proposed action, including all options is $

As applicable, briefly describe the services or supplies required to meet the agency's needs, including make & model number where appropriate. Include quantities of supplies or period of performance for services. Provide information for any options included. If the action is a modification to an existing contract, distinguish clearly between the work covered by the original contract and the work to be obtained by the proposed modification.

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4. Authority and Rationale: Identify the statutory authority, FAR title and FAR citation permitting other than full and open competition. It may be one of the following most commonly used citations by the operating divisions of the Department of Health and Human Services (HHS), but other exceptions may apply per FAR Subpart 6.3.

Actions other than simplified acquisition procedures (select only one and provide an explanation):

FAR 6.302-1: Only one responsible source and no other supplies or services will satisfy agency requirements, 41 U.S.C.

3304(a)(1)

Explain why the intended contractor is the only responsible source who can provide the required supplies or s ervices.

Discuss the unique capabilities, expertise, etc. that support the lack of competition/why no other type of supplies or servic es will satisfy agency requirements. Explain factors/unique qualifications such as proprietary data or exclusive licensing rights, if applicable. When competition is limited to items particular to one manufacturer, this justification must explain why the particular brand name, product, or feature is essential to the Government's requirements, and that market research indicates other companies' similar products, or products lacking the particular feature, do not meet, or cannot be modified to meet the agency's needs in accordance with FAR 11.105. If in connection with a follow-on contract for continued development or production of highly specialized equipment, detail the substantial duplication of cost or unacceptable delays.

FAR 6.302-2: Unusual and compelling urgency, 41 U.S.C. 3304(a)(2)

If unusual and compelling urgency is the basis for the justification, explain the chronological events leading up to the requirement and explain why time constraints cannot permit even a limited competition. Describe the detrimental effects/ serious injury to the mission of the requiring activity or to the government, financial or otherwise, that will result if this justification is not approved. Describe impact of required delivery/performance date. Describe the detrimental effects/ serious injury to the mission of the requiring activity or to the government, financial or otherwise, that will result if this justification is not approved and the product or service cannot be provided by the intended sole source contractor. Failure to plan for expiring funds is not a valid reason for citing this exception. May not exceed one year, including all options, unless the head of the agency determines that exceptional circumstances apply.

FAR 6.302-5: Authorized or Required by Statute, 41 U.S.C. 3304(a)(5)

Provide a citation to the statutory authorization and a brief description of its content, or identify the specified source or other agency.

Other (See FAR Subpart 6.3 for additional authority)

Provide the authority and citation to the applicable section of FAR 6.3.

Provide a full explanation to justify use of the exception.

5. Agency Actions to Take or Remove Barriers That Led to Other Than Full and Open Competition (If applicable):

Describe the actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration prior to any subsequent acquisition for the supplies of services is made. If no such actions have been taken, explain why.

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6. Bridge Contracts:

For contract extensions or bridge contracts when a competitive follow-on is in the process of being developed, summarize history of current contract and explain the reasons for any delays in the acquisition. Include discussion of the milestones f or the follow-on action; the milestones should be as efficient as possible. Discuss why it would be neither cost effective nor realistic to expect another contractor to perform during the brief interim period; include issues such as start -up costs, phase-in, transfer of GFP, recruitment and staffing, etc. If the action is because of a protest, provide a brief discussion of the protest including the date the protest was filed and the basis of the protest. Explain that the action will provide the minimum quant ity or performance period.

7. Actions to Increase Competition:

Describe efforts made to compete the action, including whether a notice was or will be publicized as required by FAR Subpart

5.2 or which exception under FAR 5.202 applies. If a notice was publicized, discuss the number of written responses to the synopsis and the results of the assessment of the written responses. List sources, if any, that expressed, in writing, an interest in the acquisition. Provide rationale if interested sources were rejected. If applicable, state that no other sources have expressed interest, but all offers received shall be considered. Describe what actions will be taken to increase competition before subsequent acquisition of the supplies or services is required. You may state that an action is a one-time requirement, but if a similar requirement arises, every effort will be made to compete it to the maximum extent possible. If action is sole source because of proprietary data or licensing rights and there will be a continuing need for the requirement, there must be evidence that advanced planning has been initiated to overcome the barriers to competition, or there should be documentation to support an analysis that replacement costs/licensing purchase costs outweigh the benefits of competition. If the action is a contract extension or bridge, explain actions to compete the follow-on. If action is an urgent new requirement and a competitive follow-on is anticipated, explain that efforts are underway to facilitate a full and open competition.

8. Market Research:

Describe the extent of the market research conducted to identify all qualified sources and the results thereof. “Market Research” is defined as those attempts you made to ascertain whether other qualified sources exist, and can include contact with knowledgeable experts regarding similar or duplicate requirements, contact with industry, results of a sources sought synopsis, or draft solicitations. Research of the marketplace may consist of written, electronic (i.e. email) telephonic, or world wide web inquiries. Lack of advanced planning is not an acceptable reason for the lack of market research, but true urgency may necessitate abbreviated market research that is limited to readily available historical and commercial information. If ac tion is a contract extension or bridge contract, describe the market research efforts underway or completed for the follow-on. See FAR 10.002(b)(2).

9. Procurement History:

Purchase order or contract number:

Was action competed? Yes No

If action was not competed, state the cited authority, summarize rationale, and describe the actions that were supposed to be taken to increase competition and the results thereof:

https://www.acquisition.gov/far/part-5#FAR_Subpart_5_2 https://www.acquisition.gov/far/part-5#FAR_Subpart_5_2 https://www.acquisition.gov/far/part-5#FAR_5_202 https://www.acquisition.gov/far/part-10#FAR_10_002

10.Additional Information to support the justification:

If applicable, explain why technical packages or specifications to facilitate competition were not developed or available;

describe actions taken to remedy the situation.

11. Technical / Requirements Certification: By my signature below, I certify that the supporting data included in this

J&A is accurate and complete.

Program Manager

Name:

Position Title:

Email address:

Phone:

Program Manager Supervisor (or one level above Program Manager)

Name:

Position Title:

Email address:

Signature:

Date:

12. Fair and Reasonable Price/Cost Determination: As Contracting Officer, by my signature below, I hereby determine that the anticipated price/cost to the Government for this contract action will be fair and reasonable.

Provide the basis for this determination, e.g., describe techniques to be used to determine fair and reasonable price (FAR Subpart 15.402), such as price analysis, cost analysis, cost realism. Per FAR Subpart 15.403-4(a)(1), the threshold for obtaining cost or pricing data is $750,000.

Name: Phone:

Signature: Date:

13. Contracting Officer's Approval (Required for proposed contract not to exceed $700,000 (value calculated including all options)): I hereby certify that this justification is accurate and complete to the best of my knowledge. I approve this justification subject to availability of funds, and provided that the services and supplies herein described have otherwise been authorized for acquisition.

Name: Phone:

Signature: Date:

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14. Legal Review:

All J&As greater than $68 million must have a legal review from the General Law Division of the Office of the General Counsel prior to sending it to the Department.

15. OPDIV Competition Advocate Approval (Required for proposed contract over $700,000 but not exceeding $13.5 million (value calculated including all options)):

I have reviewed this justification and find that it adequately supports other than full and open competition.

Name:

Phone:

Signature:

Date:

All J&As greater than $68 million must have a review from the Office of Small & Disadvantaged Business Utilization (OSDBU) prior to sending it to the Department. The OSDBU at their discretion may review any J&A.

16. Office of Small and Disadvantaged Business Utilization Review: (Required for contracts exceeding $68 million (value calculated including all options)):

Concur:

Non-Concur:

17. OPDIV HCA Approval (Required for proposed contract over $13.5 million but not exceeding $68 million (value calculated including all options)):

18. Department Competition Advocate (Required for contracts exceeding $68 million (value calculated including all options)):

Concur:

Non-Concur:

(The below approval paragraph is required if the cumulative contract value, including all options, exceeds $68 million.)

19. HHS Senior Procurement Executive (SPE) Approval:

Based on the foregoing justification, I hereby approve other than full and open competition for the above stated procurement, subject to the availability of funds, and provided that the services herein described have otherwise been authorized for acquisition.

State supplies/services being procured:

State the full statutory authority and FAR cite and title, consistent with paragraph 4, e.g. 41 U.S.C. 3304:

Untitled

This requirement is non-commercial in nature, as it cannot be readily procured through the commercial marketplace without substantial modification to commercial specifications.

The Period of Performance consists of a 12-month Base Period and four (4) 12-month Options Periods. The total contract value including the Base Period and all four (4) option periods is estimated as $27,942,540.

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 (and 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.

Only one contractor is capable of simultaneously meeting all of the above requirements. Section 4 provides the full justification for awarding this contract on an other-than-full-and-open-competition basis to the University of Michigan Kidney Epidemiology and Cost Center (UMKECC).

To successfully perform this work, the contractor must simultaneously satisfy all three of the following capability areas, which correspond directly to the Sources Sought Criteria evaluated under Notice No. 260109J:

Capability Area 1 — ESRD Data Collection, Risk-Adjusted Reporting, and Dialysis Facility Reports: The contractor must demonstrate expertise and experience in collecting, evaluating, and utilizing all available ESRD data to develop and distribute risk-adjusted individual Dialysis Facility Reports (DFRs), state-specific reports, region-specific reports, and dialysis organization-specific reports, including a rank-ordered, facility-specific Outcomes List. The contractor must be capable of obtaining data from all required sources, including EQRS, Medicare claims, eligibility and enrollment forms, clinical data sources, death forms, OPTN, SRTR, the Nursing Home Minimum Dataset (MDS), iQIES, and survey and certification forms, and must have an existing infrastructure integrated with the CMS Central Data Repository (CDR) System, including a current Data Use Agreement (DUA), to support the rapid and uninterrupted development and distribution of these reports.

Capability Area 2 — Transplant Program Statistical Analyses, Data Reports, and Technical Assistance: The contractor must demonstrate expertise and experience in providing statistical analyses, data reports, and technical assistance regarding transplant programs' compliance with CMS Conditions of Participation (CoPs) and performance data. The contractor must be capable of obtaining and analyzing monthly OPTN and SRTR data to produce monthly Initial Transplant Reports and annual reports constructed from a composite of metrics that identify facilities with potential performance issues, including data and statistical analyses of transplant procedures, deaths, graft failures, organ acceptance rates, and OPTN data submission rates.

Capability Area 3 — OPO Statistical Analyses, Data Reports, and Technical Assistance: The contractor must demonstrate expertise and experience in providing statistical analyses, data reports, and technical assistance regarding Organ Procurement Organizations' (OPOs) compliance with CMS Conditions for Coverage (CfCs) and performance data. The contractor must be capable of obtaining data from all available sources, including SRTR, OPTN, CDC, and CMS, to produce annual performance reports based on the two measures established in the OPO Conditions for Coverage (42 CFR Part 486 Subpart G), including a tier map of OPOs in the U.S. and an annual OPO public report with an updated users guide.

In addition to satisfying all three capability areas, the contractor must be nationally recognized for objectivity and the absence of conflicts of interest and must be capable of defending its modeling and analytical approaches before Congress, the Medicare provider community, and the general public.

Text70:

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.

CMS has determined that UMKECC is the only responsible source capable of fulfilling the requirements described in Section 3. The following qualifications and capabilities demonstrate why no other contractor can meet the agency's needs, organized by the three capability areas established in Sources Sought Notice No. 260109J.

Capability Area 1 — ESRD Data Collection, Risk-Adjusted Reporting, and Dialysis Facility Reports As the incumbent sole source contractor since the program's inception in the 1990s, UMKECC has decades of experience collecting, evaluating, and utilizing all available ESRD data to develop and distribute risk-adjusted individual Dialysis Facility Reports (DFRs), state-specific reports, region-specific reports, and dialysis organization-specific reports. UMKECC has established protocols for obtaining data from all required sources, including EQRS, Medicare claims, eligibility and enrollment forms, clinical data sources, death forms, OPTN, SRTR, the Nursing Home Minimum Dataset (MDS), iQIES, and survey and certification forms.

UMKECC has developed and continuously refined the rank-ordered, facility-specific Outcomes List, constructed from a composite of data elements that most validly and reliably identify facilities with potential noncompliance with health and safety standards. UMKECC also has demonstrated expertise in developing national data reports on the frequency of dialysis use for acute kidney injury and the prevalence of home dialysis in nursing homes.

Since 2023, UMKECC has maintained direct infrastructure integration with the CMS Central Data Repository (CDR) System, supported by an active Data Use Agreement (DUA). This existing infrastructure enables the rapid and uninterrupted development and distribution of required data reports (a capability that no new contractor could replicate without significant lead time), security clearance processing, and DUA negotiations.

UMKECC employs specialized personnel with dual clinical and statistical expertise in nephrology, transplantation, organ procurement, biostatistics, and health informatics, which are a rare combination of skills not readily available in the contractor marketplace. UMKECC has produced ESRD/Transplant/OPO reports for CMS continuously since 2005, demonstrating consistent performance and deep institutional knowledge of CMS requirements.

Capability Area 2 — Transplant Program Statistical Analyses, Data Reports, and Technical Assistance UMKECC has extensive expertise in providing statistical analyses, data reports, and technical assistance regarding transplant programs' compliance with CMS Conditions of Participation (CoPs) and performance data. UMKECC obtains and analyzes monthly OPTN and SRTR data to produce monthly Initial Transplant Reports and annual reports constructed from a composite of metrics that identify facilities with potential performance issues. These reports provide data and statistical analyses of transplant procedures, deaths, graft failures, organ acceptance rates, OPTN data submission rates, and notification of key changes within transplant programs.

UMKECC's specialized personnel possess the clinical and technical expertise necessary to develop, support, teach, and defend the complex analytical methodologies underlying these reports, ensuring that CMS, State Agencies, and surveyors have access to accurate, timely, and defensible data for oversight purposes.

Capability Area 3 — OPO Statistical Analyses, Data Reports, and Technical Assistance UMKECC has demonstrated expertise in providing statistical analyses, data reports, and technical assistance regarding Organ Procurement Organizations' (OPOs) compliance with CMS Conditions for Coverage (CfCs) and performance data. UMKECC obtains data from all available sources including SRTR, OPTN, CDC, and CMS to produce annual performance reports based on the two measures established in the OPO Conditions for Coverage (42 CFR Part 486 Subpart G). These reports include a review of the donation rate and transplantation rate for each OPO and their tier status, a tier map of OPOs in the U.S., and an annual OPO public report with an updated users guide detailing the methodology used for generating the reports. UMKECC also produces additional reports required for informing policy decisions and the operation and implementation of the OPO program on an as-needed basis.

National Reputation for Impartiality and Credibility As an academic research center, UMKECC operates independently from commercial dialysis organizations, transplant programs, and OPOs, ensuring objective and unbiased analysis across all three capability areas. UMKECC has successfully defended its risk-adjustment methodologies and analytical approaches before:

• Congressional committees;

• The Medicare provider community through transparent methodology documentation and stakeholder engagement; and

• The general public through peer-reviewed publications and presentations at national conferences.

This credibility is essential to CMS's oversight mission. The reports produced under this contract form the basis for regulatory actions, survey scheduling, and public transparency initiatives — and must be beyond reproach. No commercial vendor can offer this same level of demonstrated, independent credibility.

Why No Other Contractor Can Meet These Requirements Market research, including Sources Sought Notice No. 260109J, yielded 17 responses from both large and small businesses. Upon evaluation of each capability statement, none of the respondents demonstrated the understanding, knowledge, experience, or capability necessary to all three capability areas outlined in Section 3. No respondent possesses the unique combination of:

• Existing CMS CDR access and infrastructure — Establishing new CDR access requires extensive security clearances, technical integration, and DUA negotiations that would significantly delay report production.

• Validated ESRD-specific risk-adjustment models — Developing and validating new models would require years of effort and substantial research investment.

• National reputation for impartiality — Commercial vendors may have actual or perceived conflicts of interest with dialysis organizations or transplant centers.

• Proven ability to defend methodologies — UMKECC's academic credentials and publication record provide a level of credibility that cannot be quickly replicated.

• Comprehensive understanding of CMS oversight processes — This institutional knowledge, developed over more than 25 years, is essential for producing reports that effectively support CMS's regulatory mission across all three capability areas.

Cost and Schedule Implications of Alternative Sources Transitioning this work to a different contractor would result in:

• Substantial duplication costs for infrastructure development, data system integration, model development, and personnel training;

• Unacceptable delays of at least 12–18 months, during which critical ESRD/Transplant/OPO oversight reports would be unavailable or incomplete;

• Risk to CMS oversight activities, as State Agencies and surveyors depend on these reports for survey scheduling, facility monitoring, and quality improvement initiatives; and

• Loss of methodological continuity, making year-over-year comparisons difficult and potentially undermining the validity of trend analyses.

Given the critical nature of these reports to CMS's oversight responsibilities and the substantial costs and risks associated with transitioning to an alternative contractor, UMKECC represents the only responsible source capable of meeting the agency's requirements as described in Section 3.

CMS is committed to integrating competitive market development and strategic acquisition planning as core objectives in all future industry engagement activities, including presenting or speaking at relevant events to maximize visibility and attract new entrants to the field. As part of the most recent market research effort, Sources Sought Notice No. 260109J was issued and 17 responses were received from seven (7) from small businesses, nine (9) from large businesses, and one (1) from a business of unknown size. Upon evaluation, no respondent was deemed capable of performing the required work, reflecting the inherently limited pool of vendors with the requisite expertise and capabilities.

Despite CMS's ongoing and good-faith efforts to expand competition, current market conditions and the highly specialized nature of this programmatic requirement have resulted in a situation where no vendors other than UMKECC are presently capable of fulfilling the requirement. CMS will continue to pursue all practicable measures to remove barriers to competition and broaden the competitive landscape for future acquisitions.

QSOG conducted market research to identify vendors capable of performing the work described in the Statement of Work (SOW). Research methods included reviews of General Services Administration (GSA) vendor listings, company websites, industry publications, and past performance records. No vendors were identified with the qualifications necessary to perform the required services.

In addition, a Pre-solicitation/Sources Sought Notice 260109J was posted to beta.sam.gov on May 12, 2025 seeking information on the availability and capability of qualified contractors, including small businesses, 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.

Seventeen (17) responses were received. To be deemed capable, vendors were required to demonstrate understanding, knowledge, experience, and capability across all three (3) criteria outlined in the notice. Any respondent failing to satisfy even one criterion was assessed as "not capable." Upon evaluation, none of the respondents met this threshold. While no additional sources have expressed interest to date, all offers received will be considered in accordance with applicable acquisition regulations.

CMS has carefully evaluated whether the current requirements are overly restrictive and whether modifications could broaden competition. It has been determined that the minimum technical requirements cannot be reduced or altered without compromising the quality and integrity of the statistical analyses, dialysis facility reports, and transplant and OPO reporting measures that this contract must produce.

QSOG is actively collaborating with other CMS components to review existing contracts and assess whether any current vehicles or vendors may be capable of meeting the agency's needs through comparable statistical analysis, data modification, and reporting capabilities.

CMS is committed to expanding the competitive landscape for future iterations of this work. The following actions will be considered as part of ongoing acquisition planning:

• Request for Information (RFI) / Sources Sought Notice Issue a formal RFI or Sources Sought notice on SAM.gov prior to the next acquisition cycle to gauge market interest and identify new potential offerors.

• Industry Day / One-on-One Sessions Host a virtual or in-person Industry Day to brief potential vendors on the scope of work and technical requirements, lowering barriers to entry.

• Unbundling of Requirements Evaluate whether any components of the requirement can be separated into smaller, more discrete task areas to allow a broader range of vendors, including small businesses, to compete on portions of the work.

• Small Business Outreach Engage with the CMS Office of Acquisition and Grants Management (OAGM) Small Business Program and the SBA to identify small businesses with relevant ESRD or healthcare data capabilities.

• Academic & Research Institution Engagement Explore partnerships or subcontracting arrangements with universities or research institutions that have ESRD expertise, potentially expanding the vendor pool.

• Mentor-Protégé Program Encourage the incumbent or other large businesses to participate in the SBA Mentor-Protégé Program to develop small business capacity in this niche area.

• Revised/Simplified Statement of Work (SOW) Review the SOW to ensure requirements are not overly restrictive and that they reflect the minimum necessary qualifications, reducing unintentional barriers to entry.

• Longitudinal Market Research Conduct and document ongoing (not just pre-solicitation) market research throughout the contract period to build a stronger competitive record for future acquisitions.

QSOG conducted market research to identify vendors capable of performing the work described in the Statement of Work (SOW). Research methods included reviews of General Services Administration (GSA) vendor listings, company websites, industry publications, and past performance records. No vendors were identified with the qualifications necessary to perform the required services.

Additionally, Pre-Solicitation/Sources Sought Notice No. 260109J was posted to SAM.gov on May 12, 2025, seeking information on the availability and capability of qualified small and large business contractors, able to provide CMS with 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.

Capability Evaluation Results Seventeen (17) responses were received. To be deemed capable, vendors were required to demonstrate understanding, knowledge, experience, and capability across all three (3) criteria outlined in the notice. Any respondent failing to satisfy even one criterion was assessed as "not capable." Upon evaluation, none of the respondents met this threshold. While no additional sources have expressed interest to date, all offers received will be considered in accordance with applicable acquisition regulations.

Incumbent Contractor — UMKECC (The Regents of the University of Michigan) Although UMKECC did not submit a formal capability statement, the incumbent has delivered this work to CMS since the 1990s, demonstrating exceptional and sustained performance. Over more than three decades, UMKECC has developed:

• Comprehensive institutional knowledge of the ESRD program;

• Established data management systems and refined analytical methodologies; and

• A consistent record of meeting and exceeding CMS requirements.

Basis for Sole Source Determination CMS has determined that the following capabilities are essential to successful performance and are exclusively available through UMKECC:

• Established infrastructure for the rapid and timely development and distribution of specialized data reports;

• Highly specialized knowledge of accessing, downloading, and integrating multiple complex data systems;

• Operational experience integrating clinical and technical expertise with specialized data systems; and

• A nationally recognized reputation for integrity and accuracy, critical given that these reports inform authoritative decision-making by Congress, Federal agencies, the renal care community, and the public.

While other contractors may possess general data management and statistical capabilities, only UMKECC has the depth of knowledge, specialized experience, and national reputation required for this program.

Additional Qualifications UMKECC maintains extensive knowledge of the CMS survey process for ESRD, Transplant, and OPO programs and has provided direct training to CMS surveyors. UMKECC consistently delivers high-quality work products, repeatedly exceeding performance expectations through thoughtful analysis and expert technical guidance.

Text85: Legislative History:

Through the legislative mandate of the Balanced Budget Act (BBA) of 1997, a method to measure and report the quality of services in ESRD facilities is required. In 1977, Congress passed the BBA. Section 4558(b) of the BBA, titled Renal Dialysis Related Services, Implementation of Quality Standards, directs the Secretary of Health and Human Services to develop and implement a method to measure and report quality of ESRD services provided under the Medicare program under title XVIII of the Social Security Act. CMS has been assigned responsibility for the development and implementation of this section of the BBA. As a part of this BBA implementation effort, CMS develops facility-specific and state-specific reports that are used by CMS and States to focus and structure their review of ESRD facilities.

Legislative History:

Through the legislative mandate of the Balanced Budget Act (BBA) of 1997, a method to measure and report the quality of services in ESRD facilities is required. In 1977, Congress passed the BBA. Section 4558(b) of the BBA, titled Renal Dialysis Related Services, Implementation of Quality Standards, directs the Secretary of Health and Human Services to develop and implement a method to measure and report quality of ESRD services provided under the Medicare program under title XVIII of the Social Security Act. CMS has been assigned responsibility for the development and implementation of this section of the BBA. As a part of this BBA implementation effort, CMS develops facility-specific and state-specific reports that are used by CMS and States to focus and structure their review of ESRD facilities.

The Federal Registry Conditions of Participation for organ transplant programs at 42 C.F.R. §482.72 through §482.104 require CMS to provide oversight for Transplant Programs. Data reports and technical assistance are required to follow the requirements stipulated in the Transplant Conditions of Participation. The contractor will provide technical assistance and support to CMS and surveyors in support of the data reports and data policy development for oversight of the transplant programs.

The Federal Registry Conditions of Coverage for Organ Procurement Organizations at 42 C.F.R. §486.301 through §486.360 require CMS to provide oversight for Organ Procurement Organizations (OPO)s. Data reports and technical assistance are required to meet the requirements stipulated in the regulation. The contractor will provide technical assistance and support to CMS and surveyors in support of the data reports and data policy development for oversight for the OPOs.

Contractual History:

This requirement for CMS has been under a sole-source contract with the University of Michigan/Kidney Epidemiology and Cost Center (KECC) since its inception in the 1990s. KECC has done high-quality contract work in data development and reporting for CMS, NIH, HRSA, and AHRQ for many decades. CMS currently has a contract with Regents of the University of Michigan, which was awarded via sole- source on September 30, 2021, and expires on September 29, 2026. The contractor has performed successfully and has provided significant added value to CMS in providing detailed data reports about ESRD, Transplant Programs, and OPOs. The contract type of this previous effort was Firm Fixed Price (FFP). The total contract value was $18,501,472.00. The following is a procurement history of this requirement:

• HHSM-500-2021-75FCMC21C0035, 09/30/2021- 9/29/2026, Regents of the University of Michigan

• HHSM-500-2016-00085C, 09/22/2016 to 9/29/2021, Regents of the University of Michigan

• HHSM-500-2011-0091C_ESRD_Regents of U. of Michigan, 2011-2016, Utilization of Data Indicators in the ESRD,

• HHSM-500-2006-00042C, Transplant, and Organ Procurement Organizations’ Survey Processes 2006-2011,

• HHSM-500-2005-0031I/0001, End Stage Renal Disease Measures Support, Arbor Research Contract/UMKECC, 2005-2010,

• HHSM-500-2008-00021I, ESRD Measure Development and Maintenance Arbor Research/UMKECC.

Price realism analysis will be performed, if necessary, in accordance with the methodology set forth in FAR 15.404-1(d).

Normally, adequate price competition establishes a fair and reasonable price ((see 15.403-1(c)(1)(i)). Since this is a sole-source procurement, there is not adequate price competition.

Therefore, in addition to a price analysis, a cost analysis will also be performed on the sole offeror’s proposed price.

Price Analysis Price analysis is the process of examining and evaluating a proposed price without evaluating its separate cost elements and proposed profit. The proposed Firm Fixed Price (FFP) was compared to historical prices for the same services performed by UM/KECC.

Cost Analysis Cost analysis is the review and evaluation of any separate cost elements and profit or fee in an offeror’s or contractor’s proposal, as needed to determine a fair and reasonable price or to determine cost realism, and the application of judgment to determine how well the proposed costs represent what the cost of the contract should be, assuming reasonable economy and efficiency.

Text1: $27,942,540