JOFOC 6.17.21.final.pdf

DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Medicare & Medicaid Services

7500 Security Boulevard, Mail Stop B3-30-03

Baltimore, Maryland 21244-1850

Acquisition and Grants Group

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

Acquisition Title: Data Analysis for the Quality, Safety & Oversight of the End Stage Renal

Disease (ESRD) Dialysis, Transplant, and Organ Procurement Organization

(OPO) Programs

Agency: Department of Health and Human Services

Centers for Medicaid & Medicare Services (CMS)

Acquisitions and Grants Group

Division of Beneficiary Support Contracts

Fiscal Year: 2021

Author: Jean Sillon / Brian Humes / Michele G W Brady

1. Description Of Action:

Nature x_ New Requirement

Follow-On Order

Modification of Existing Contract Number

Contract Type x_ Firm-Fixed Price

Time and Materials

Cost Plus Fixed Fee (CPFF)

• Term

• Completion

Cost Plus Award Fee (CPAF)

Other: _

Projected Cost / Price of contract (Base & All Options): $12,092,316.27

The total estimated value of the proposed sole source action (for modifications only): N/A

Funding Source (s): Annual Appropriations

: Basis for Approval (Far 6.303-1(d))

: Individual Basis

: Class Basis

Name of Proposed Contractor(s): Regents of University of Michigan Kidney

Epidemiology and Cost Center (UM/KECC)

Street Address: Wolverine Tower, RM 1040, 3003 South State Rd

City, State, Zip: MI, 48109-1274

2. Nature and/or Description of the action being approved:

This justification for other than full and open competition applies to a single new requirement. It is imperative that CMS negotiate a sole-source contract through other than full and open competition with the proposed contractor: Regents of University of

Michigan Kidney Epidemiology and Cost Center (UM/KECC). This firm-fixed price contract is to produce detailed data reports about End Stage Renal Disease (ESRD) dialysis facilities, Transplant Programs, and Organ Procurement Organizations (OPOs) in formats that are useful to the Centers for Medicare & Medicaid Services (CMS), States, health care providers and the general 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 overseeing the quality and safety of the ESRD, Transplant and OPO Programs within

CMS. The contract actions associated with this justification will be for one year, with four option periods. The base period of performance is expected to be from September

30, 2021 through September 29, 2022. This requirement is considered non-commercial in nature, in that it cannot be readily procured through the commercial marketplace with little to no changes to commercial specifications.

3. A Description of the Supplies or Services Required to Meet the Agency’s Needs

The Centers for Medicare & Medicaid Services (CMS) has a need to purchase the services of a 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

Outcomes Lists. In addition, this contract includes developmental, implementation, data research, and data integration work related to CMS’s automated ESRD survey process, using PC Tablet technology. The total estimated value of the contract for five (5) years is

$12,092,316.27.

The contractor needs to have an infrastructure in place that will support the rapid development and distribution of these various data reports. The contractor needs to be 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. The contractor needs to have a national reputation for fairness and lack of conflicts-of-interest in their work. The contractor needs to be able to successfully defend their modeling and analysis to the Congress, the public and the Medicare provider community.

The contractor needs to understand the ESRD/Transplant/OPO health delivery system;

the survey and certification process for these providers; the use of data in these 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. Specifically, the contractor needs to meet the following technical criteria in addition to having a national reputation for this specific work:

1. The contractor needs to understand and have experience with all aspects of the various ESRD/Transplant/OPO data systems (including the National Healthcare

Safety Network data system); the operations required for accessing and downloading these data systems, and national and international research on relevant data systems and clinical performance measures to develop appropriate data reports on the most meaningful outcome measures and practice patterns.

2. This contractor must have experience in developing summary reports that are risk-adjusted and facility-specific, State-specific, Regional-specific, and corporate-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.

3. The contractor needs to have knowledge and experience regarding the

ESRD/Transplant/OPO survey and certification process. The contractor needs to understand the program-specific survey and certification data bases and any updates: Online Survey Certification & Reporting (OSCAR), Automated Survey

Processing (ASPEN), Certification and Survey Provider Enhanced Report

CASPER), Internet Quality Improvement and Evaluation System (iQIES) and the

CMS Central Data Repository (CDR).

4. The contractor needs to have experience in and an understanding of the use of renal transplant and organ procurement data bases from the Health Resources and Service

Agency (HRSA) and the Organ Procurement and Transplant Network (OPTN); Part

A and Part B Medicare claims and enrollment data for ESRD and Transplant enrollees; ESRD Network data; Centers for Disease Control and Prevention (CDC)

ESRD epidemiological data; Fistula First Dashboard; data from the Social Security

System; and the various ESRD Network-based data systems. The contractor needs to be able to use these data in comparative and rank-ordered reports for quality purposes.

5. The contractor needs to have experienced personnel with the appropriate clinical and technical skills to develop, support, teach, and defend a series of comparative, and rank-ordered facility-level quality reports from individual and facility-level data.

These reports need to be posted on a secure Website and distributed in a timely manner.

There is only one contractor who meets these requirements. The following is the justification for other than full and open competition for the University of Michigan’s

Kidney Epidemiology and Cost Center (UM/KECC).

4. Statutory Authority

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.

5. A Demonstration That the Proposed Contractors Unique Qualifications or the

Nature of the Acquisition Requires Use of the Authority Cited

University of Michigan/Kidney Epidemiology and Cost Center (UM/KECC) holds unique qualifications for this requirement. UM/KEEC has successfully performed this work under contracts HHSM-500-2006-00042C; HHSM-500-2011-00091C; and, HHSM-500-2016-00085C. 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. UM/KECC has been working with other contractors on the utilization and development of new, integrated data systems for CMS.

The Statement of Work for this contract requires the contractor to assign specific patients with their longitudinal treatment history, to specific facilities and the timeframe for each patient assignment. This data is used as a basis for risk-adjusted, facility-specific quality measures. Additionally, it requires the contractor to provide technical assistance and support to CMS and CMS Regions in support of the data reports and data policy development for oversight of the OPO programs. UM/KECC currently has the unique combination of data, experience, and interest to meet this requirement. While there may be other organizations that may be capable of meeting this requirement in the future, there are no known interested vendors that have the unique combination of skills and experience described above based on the market research results. Regents of the

University of Michigan is the only source that has demonstrated the mandatory combination of specialization and expertise in statistical analysis for the ESRD, transplant and Organ Procurement Organizations to continue to update and maintain the

Dialysis Facility Reports for the ESRD community, beneficiaries and providers.

UM/KECC has demonstrated the ability to create, maintain and modify as needed all of the statistical analysis methods, reporting structures, report creation and data verification to oversee the End Stage Renal Disease, Transplant and Organ Procurement

Organization Programs. They have been maintaining the largest ESRD database and have prepared risk-adjusted facility-level reports for over 5,000 dialysis facilities. They are in the process of creating new Transplant metrics to evaluate and guide the State survey processes and create the new Organ Procurement Measures to ensure the OPOs are meeting CMS quality requirements.

As described in this JOFOC, the program office intends to expand market research efforts in an attempt to compete future requirements for these services. However, currently UM/KECC, with decades of clinical and statistical experience in aggregating patient-level and facility-level data, is the only contractor that has been able to accomplish this work.UM/KECC is nationally recognized as being a fair contractor, operating without conflicts-of-interest. Additionally, UM/KECC is nationally known for its work in ESRD/Transplant/OPO risk-adjusted modeling, statistical management of data, and 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 has contracts 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.

For these reasons, CMS intends to contract with UM/KECC on the Data Analysis for the

Quality Safety & Oversight of the Utilization of Data Indicators in the End Stage Renal

Disease (ESRD) Dialysis, Transplant, and Organ Procurement Organization (OPO)

Programs

6. Efforts Made to Ensure that Offers are Solicited from as Many Potential Sources as

Practical

The Quality Safety & Oversight Group (QSOG) researched potential GSA companies that could potentially provide the type of work requiring of what is outlined in the Statement of

Work using company websites, industry articles, and past performance experience. No venders were identified that could provide the appropriate services. In addition, a Sources

Sought Notice was published in Beta.sam.gov on February 8, 2021. Vendors were provided the opportunity to review the three primary tasks of the Statement of Work, which were included in the Sources Sought Notice to assist them in determining their capability to meet the program’s requirements. Two vendors, including one (1) small business, responded to the notice and provided capability statements. Both capability statements were reviewed, and neither demonstrated their capability to perform the same or similar size and scope of work as required in the sources sought notice.

CMS has considered if the requirement is too restrictive and if it was possible to alter the requirements to be less restrictive. However, the minimum requirements to meet contract needs cannot be altered to be able to produce the same level of statistical analysis, dialysis facility reports or transplant and Organ Procurement Organization new reporting measures.

In the future, CMS plans to market the expectations and requirements of this work among other vendors in order to stimulate interest in competitive bidding. The Quality Safety &

Oversight Group (QSOG) is working with other CMS components to review existing contracts to see if they are capable of meeting agency needs through similar statistical analysis creation, modification and reporting.

For historical context of previous efforts to ensure offerors were solicited from as many potential sources as possible, the following information is provided:

In 2006, seven vendors, four of whom were small businesses, responded to the synopsis/sources sought with capability statements. All four small business capability statements were reviewed and none were found to meet the criteria necessary to successfully perform this requirement. Foremost among the criteria 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. The contractor must be free of conflict of interest both in reality and in appearance. Therefore, the services were procured through sole source per FAR 6.302-1(a)(2) to University of

Michigan/Kidney Epidemiology and Cost Center (KECC), contract #HHSM=500-2006-

00042C.

In 2011, a synopsis/sources sought advertising this contracting opportunity was published in FedBizOpps on June 2, 2011. Five vendors, three of whom were small businesses, responded to the synopsis with capability statements. All five capability statements were reviewed. None were found to meet the criteria necessary for this requirement. Consequently, the procurement was not competed because the services requested from CMS were available from only one source. As such, the services were procured through sole source per FAR 6.302-1(a)(2) to University of Michigan/Kidney

Epidemiology and Cost Center (KECC), contract # HHSM-500-2011-00091C.

In 2016, a synopsis/sources sought for this requirement was published in FedBizOpps on June 3, 2016. No vendors responded to the synopsis with capability statements or other comments. Therefore, the services were procured through sole source per FAR

6.302-1(a)(2) to University of Michigan/Kidney Epidemiology and Cost Center

(KECC), contract # HHSM-500-2016-00085C.

In all of the above efforts to ensure offerors were solicited from as many potential sources as possible by issuing a synopsis/sources sought, there is no common theme identified as to why the respondents are consistently deemed not capable. In the most recent response to the synopsis/sources sought that was issued on 02/08/21, the answers to the questions were very broad and general and did not explain their ability to complete the work. Some of the work discussed in the Sources Sought responses didn’t have anything to do with statistical analysis, which is a requirement of this contract.

The University of Michigan/Kidney Epidemiology and Cost Center (KECC) has received a rating of “satisfactory” or higher on all previous CPARS evaluations for the previous contracts mentioned above.

7. A Determination by the Contracting Officer That the Anticipated Cost to the

Government Will Be Fair and Reasonable Cost

CMS has been doing business with UM/KECC for many years and therefore has substantial historical pricing information available. Prior to award, the Contracting

Officer will determine that the anticipated cost to the Government is fair and reasonable.

8. A Description of the Market Survey Conducted or a Statement of the Reasons a

Market Survey Was Not Conducted

A market survey was conducted with a sources sought notice published in Beta.Sam on

February 8, 2021. As previously mentioned, only two (2) vendors: Vetshare LLC and

IMPAQ International LLC responded to the notice with capability statements. After reviewing the vendors’ responses, CMS determined that neither of the respondents met the overall requirements to perform the highly technical, highly specialized work that needs to be completed for this requirement.

CMS has determined that the need for an established infrastructure that can ensure the rapid and timely development and distribution of these specialized data reports; the highly-specialized knowledge about accessing, downloading, and integrating various data systems; the operational experience related to integrating in-depth clinical and technical expertise with the variety of available specialized data systems; and the national reputation for integrity and accuracy mandated for this project are only available with

UM/KECC. Because the data reports are used for authoritative decision-making, the

Congress, the Federal government, the renal community, and the public must be confident that the reports are accurate and unbiased. While other contractors may have data management and statistical skills, only UM/KECC has the in-depth knowledge, specialized experience, and authoritative national reputation required for this project.

UM/KECC also has strong knowledge about and has taught to surveyors the current CMS survey process for ESRD, Transplant, and OPO programs. UM/KECC consistently delivers high quality deliverables that meet the needs of the government. They have continued to exceed expectations and provided thoughtful and insightful analysis and technical guidance to the government.

Concur:

9. Other Facts Supporting the Use of Other than Full and Open Competition

None

10. Sources Expressing in Writing an Interest in This Acquisition

CMS believes that no other contractor is in a position to provide these services.

11. Actions the Agency May Take to Remove or Overcome Any Barriers to Competition

The ESRD field is a small, specialized area. CMS will continue to stay current with the field and look for other potential contractors for this work. The program office will continue to attend regular trade shows and other similar events, which allows the program office to stay on top of new companies in the field as well informing the industry of the opportunities in regards to this effort. Moving forward the program office intends to make acquisition planning and competitive market development a key aspect of our goal while attending or speaking at these events. As noted above, current market research was performed and only two (2) responses were received consisting of one small business and a large business.

While CMS will continue to take actions to remove or overcome any barriers to competition, at this point, and taking into account the history of this programmatic need, no other vendors are able to perform the requirement.

12. Recommendation/approval:

For the reasons indicated above, it is recommended that a sole-source contract in the estimated amount of $12,092,316.27 (inclusive of all option periods) be awarded to UM/KECC for the project titled “Data Analysis for the Quality, Safety & Oversight of the End Stage Renal

Disease (ESRD) Dialysis, Transplant, and Organ Procurement Organization (OPO)

Programs.”

(a) This certifies that, to the best of my knowledge and belief, the data necessary to support the recommendation for other than full and open competition are accurate and complete, as required by FAR subsection 6.303-1(b).

June 15, 2021

Michelle Walton, COR Date

Division of Continuing & Acute Care Providers

David R. Wright -S Wright -S

Digitally signed by David R.

Date: 2021.06.16 12:56:02 -04'00'

Stephanie Mozgai, Director

Division of Continuing & Acute Care Providers

David Wright, Director Quality Safety & Oversight Group

Date

Date

(b) This is to certify that, to the best of my knowledge and belief, this justification for other than full and open competition is accurate and complete, as required by FAR subsection 6.303-1(b).

RECOMMENDATION:

Jean Sillon Date Contract Specialist

CONCUR:

Brian Humes Date Contracting Officer

Debra A. Hoffman Date Division Director, DBSC

Jason Vollmer Date Group Director, AGG

Stefanie Mozgai Mozgai

Digitally signed by Stefanie

Date: 2021.06.15 08:27:23 -04'00'

APPROVE:

Derrick Heard Date Acting Director, OAGM