NDSC Bridge Justification and Approval Final2_SIGNED_Redacted.pdf

CLASS JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity, and specific identification of the document as a "Justification for other than full and open competition."

Department of Veterans Affairs (VA) Office of Procurement, Acquisition and Logistics Strategic Acquisition Center (SAC) 10300 Spotsylvania Ave, STE 400 Fredericksburg, VA 22408

2. Nature and/or description of the action being approved The purpose of this acquisition is for the use of Federal Acquisition Regulation (FAR) Part 6.301-2 (a)(2) Unusual and Compelling Urgency to award nine non-competitive Firm Fixed Price (FFP) Indefinite Delivery Indefinite Quantity (IDIQ) bridge contracts for Veteran Dialysis Services in the Community. The bridge contracts under the current National Dialysis Service Contracts (NDSC) are displayed below. Individual requirements will be authorized for Veteran care in the community by qualified medical personnel and assigned by community care coordinators for dialysis care in accordance with Veteran proximity to care and specified modality.

The current NDSC bridges will expire on September 30, 2025 and the follow-on effort will not be awarded before the current bridge contracts expire or in time to complete the 90-day implementation period.

CONTRACT PROVIDER

36C10G24D0064 American Renal Associates 36C10G24D0088 Atlantis Healthcare Inc.

36C10G24D0092 Central Florida Kidney Center 36C10G24D0093 DaVita Inc 36C10G24D0094 Dialysis Clinic Inc 36C10G24D0095 Dialysis Newco, Inc.

36C10G24D0088 Fresenius Medical Care Holdings, Inc.

36C10G24D0089 RSA - Guam 36C10G24D0096 US Renal Care, Inc.

3. A description of the supplies or services required to meet the agency’s needs (including the estimated value):

Class Justification & Approval – National Dialysis Services Bridge Contracts 2.0

The current Veterans Health Administration (VHA) NDSC provide dialysis services performed in all areas of the United States, the District of Columbia, Puerto Rico, Guam, the U.S. Virgin Islands, American Samoa, and the Commonwealth of the Northern Mariana Islands. The current dialysis capability within Veterans Affairs Medical Centers (VAMCs) and the Community Care Network (CCN) is insufficient to address the needs of the entire Veteran population that requires dialysis services.

Healthcare providers in the community offer dialysis services nationwide for Veterans as authorized by the VAMCs. The providers deliver, supervise, and monitor dialysis services for chronic hemodialysis (outpatient), home hemodialysis, chronic peritoneal (outpatient) dialysis, Acute Kidney Injury (AKI), and training sessions for home-based hemodialysis and peritoneal dialysis. The providers’ facilities are located within the geographic locations of the referring VAMCs and are readily accessible to the Veteran patient population within the Veteran Integrated Service Networks (VISNs). The healthcare provided is delivered in a manner consistent with the needs of the Veterans and standards of quality delivered to the providers’ non-VA patients. Personnel assigned by the providers are licensed by State, Territory, or Commonwealth of the United States or the District of Columbia.

The contracts provide critical healthcare services to the Veterans who are unable to receive dialysis care from VHA. Approximately 19,000 Veterans are currently receiving dialysis services through the NDSC. A gap in contractual coverage would have catastrophic results outside of just a lapse in care/coverage. Dialysis services are not optional for Veteran patients with chronic renal failure. It is imperative that no lapse in coverage occurs, as any delay in dialysis service can lead to serious health consequences, including a buildup of toxins and fluids in the blood and potential loss of life.

The VA has an urgent need for these services to provide Veterans with life-saving healthcare and prevent adverse outcomes from lack of care beginning at the time the current bridge contracts expire (September 30, 2025). The new bridge contracts will consist of a base period of six-months (October 1, 2025 – March 31, 2026) and two three-month option periods (April 1, 2026 – June 30, 2026), and July 1, 2026- September 30, 2026. It is anticipated that the new long-term contracts will be awarded prior to the expiration of the new bridge contracts.

4. An identification of the statutory authority permitting other than full and open competition.

The statutory authority that permits this action is 41 U.S.C. 3304(a)(2) as implemented by FAR Part 6.302-2, Unusual and Compelling Urgency.

5. A demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

NDSC community dialysis services bridge contracts are vital to ensure continuity of care for some of our country’s most vulnerable Veterans, while the follow-on procurement is underway, which will be fully compliant with the MISSION Act.

Currently there are nine IDIQ bridge contracts awarded to nine dialysis contractors that are currently providing service to over Veterans. The current bridge contracts will expire on September 30, 2025. Once they expire, no Veterans will be able to receive lifesaving dialysis treatments. The follow-on procurement is in process and is currently behind schedule due to multiple reasons outlined in this acquisition package. The current estimated award date of the follow-on acquisition is October 1, 2025. Factoring in the 90-day re-authorization period required, it is absolutely essential to award new bridge contracts to ensure the continuation of these vital services.

For the follow-on procurement, VHA recognized the need to enhance oversight of community clinical quality and ensure optimal coordination of care between dialysis facilities, nephrologists, and the VA provider. This review caused significant delay in the timeline of the follow-on procurement and is discussed more in depth below. Furthermore, VA is re-examining the overall requirement as a whole to determine the best strategy based on recent industry feedback from Requests for Information (RFIs), which has also caused additional delays in the follow-on procurement timeline.

Due to these changes in the NDSC format, the award of the follow-on NDSC contract has been delayed enough that new bridge contracts are the only way to ensure dialysis services to Veterans do not end on September 30, 2025, when the current bridge contracts expire.

The VA Medical Centers (VAMC) lack the capacity necessary to address the Veteran population requiring dialysis; therefore, utilizing Government personnel is not feasible.

Further, there is insufficient network adequacy within the CCN contracts at this time. If this action is not approved, the result would be a break in services that would jeopardize Veterans’ healthcare in the community, impacting their health, safety and their livelihood.

There is an evident and ongoing need for both hemodialysis and peritoneal dialysis for an increasing population to treat chronic kidney disease. The original 2019 contracts were set up to streamline the ordering of dialysis services across the nation using private healthcare companies. Additionally, the 2019 contracts were set up to mirror the Medicare methodology for treating End-Stage Renal Disease (ESRD).

While the follow-on procurement for the new dialysis contracts is underway, the contracts under this effort will ensure continued healthcare services for Veterans and ensure the prevention of detrimental health circumstances to include loss of life.

VA needs providers that are immediately capable of meeting the contractual requirements and have the required capabilities and facilities to provide the necessary dialysis services for Veterans without interruption or degradation of the quality of care.

The proposed contractors are immediately capable and have demonstrated the requisite expertise, management, responsiveness, and experienced personnel critical to providing seamless, uninterrupted service of current delivery of dialysis services.

For the reasons stated, the award of bridge contracts to the current NDSC contractors is in the best interest of the VA to avoid disruption of life-saving dialysis services to Veterans. Approval of these bridge contracts will prevent a catastrophic impact to VA’s ability to provide and support world-class patient care to our nation’s Veterans while going through the solicitation and award process of the follow-on NDSC.

6. A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by subpart 5.2 and, if not, which exception under 5.202 applies.

Notice of this J&A will be publicized in accordance with FAR Subpart 5.2. No efforts to solicit additional potential sources for this bridge action was conducted. VAMCs would not have time to re-authorize care before September 30, 2025, for the Veterans receiving care under these contracts. The effort to award a fully competitive action for these services would be impossible to achieve. Multiple RFIs to solicit as many interested sources as possible have been issued within the acquisition process of the new procurement. It is anticipated that there are multiple vendors both interested in and capable of providing the required services under the follow-on competitive procurement.

A determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable The Contracting Officer hereby has determined that the anticipated cost to the Government is fair and reasonable in accordance with FAR 15.404-1(b)(2)(ii) and FAR 15.404-1(b)(2)(v). In 2019, when the five-year NDSC contracts were competitively awarded, each rate was analyzed and determined to be fair and reasonable. The same rates will be used in the new bridge contracts. The increase in overall price represents the estimated increase in utilization, based on the Veteran dialysis population growth, from approximately to almost . Comparing the proposed rates under this action and the historical pricing from 2024 and 2019, the rates remain unchanged and hereby determined to be fair and reasonable.

A description of the market research conducted (see part 10) and the results or a statement of the reason market research was not conducted.

As noted above, market research for the follow-on acquisition of NDSC is underway to maximize competition. The VHA Integrated Veteran Care Program Manager has implemented an Integrated Procurement Team with all stakeholders. Multiple requests for Information (RFIs) have been issued with multiple respondents, and there are at least nine existing sources that are capable of satisfying the agency’s requirements under the NDSC program. Based on the market research effort, maximum competition is anticipated for the follow-on effort.

Any other facts supporting the use of other than full and open competition, Concurrence

Based on the foregoing justification, I hereby approve this acquisition on an “other than full and open competition” basis pursuant to the statutory authority cited in paragraph four above, subject to availability of funds, and provided that the property and services herein described have otherwise been authorized for acquisition.

Christopher D. Parker Associate Executive Director, Strategic Acquisition Center, and Acting Associate Executive Director, National Acquisition Center

Approval

Based on the foregoing justification, I hereby approve this acquisition on an “other than full and open competition” basis pursuant to the statutory authority cited in paragraph four above, subject to availability of funds, and provided that the property and services herein described have otherwise been authorized for acquisition. As this action exceeds $75M, the certification below required by FAR 6.304 serves as approval.

Joseph Maletta Acting Executive Director Office of Acquisition and Logistics, and Senior Procurement Executive

CHRISTOPHER

PARKER

Digitally signed by CHRISTOPHER

PARKER

Date: 2025.07.01 10:47:42 -04'00'

JOSEPH

MALETTA

Digitally signed by

JOSEPH MALETTA

Date: 2025.07.02 15:50:48 -04'00'