P03_LSJ OVER SAT 09-01-2024 ABECMA.AG final.pdf

Attachment 2: Request for Limited Sources Justification Format >SAT

VHAPG Part 808.405-6 Limiting Sources Page 1 of 4 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C249-25-AP-1684

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID:36C249-25-AP-1684

(1) Contracting Activity: Department of Veterans Affairs, Network/Program Contracting Office 09, located at 1639 Medical Center Parkway, Suite 204, Murfreesboro, TN 37129 in support of Veterans Integrated Service Network (VISN) 09 VA Health Care System at Tennessee Valley Healthcare Services, Nashville, TN 37212.

(2) Description of Action: This acquisition is conducted under the authority of the Multiple- Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501).

Order against FSS Contract Number: 36F79724D0101

Name of Proposed Contractor: Bristol-Myers Squibb Company

Street Address: 3401 Princeton Pike

City, State, Zip: Lawrenceville, NJ 08648

Phone: 609-302-4897

(3) Description of Supplies or Services:

The estimated value of the proposed action is $ 338,932.84 This is a procurement to provide Antineoplastic/BCMA-directed CAR-T cell immunotherapy approved for a veteran patient.

(4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays: ABECMA is a prescription medicine used to treat adults with relapsed or refractory multiple myeloma. The prescription is based upon consultation between the doctor and patient and has been prescribed as part of their treatment plan.

FAR 8.405-6(a)(1)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized;

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FAR 8.405-6(a)(1)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.

FAR 8.405-6(b): Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition. The proprietary data is:

These are “direct replacements” parts/components for existing equipment.

The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing.

(5) Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination:

VHA Procurement Guide Part 808.405-6 Limited sources paragraph 1.1 states the following:

“Note for pharmaceutical purchases under the SAT: When conducting research utilizing the “VA National Acquisition Center Contract Pharmaceutical Catalog” Search Tool” and it appears that the required medication (s) is only available from one FSS contract holder the CO will take a screenshot and upload to the eCMS briefcase showing no other FSS contract holders are available. Based on this evidence along with the customer’s completion of Attachment 13 Pharmaceutical Procurements, no LSJ would be required.”

This requirement does not fall under the SAT, therefore, a Limited Source Justification is being completed even though this medication is only available from one FSS Contract Holder. The Department of Veterans Affairs Federal Supply Schedule has negotiated and awarded 36F79724D0101 to Bristol-Myers Squibb Company under the Multiple Award Schedule 65 I B (Pharmaceuticals and Drugs) category 42-2A (Single source drug, innovator multiple source drug, and any biological identified under Section 600.3 of Title 21, CFR).

Based upon a search of the Department of Veterans Affairs Contract Catalog Search Tool (CCST) Pharmaceutical Catalog Search found at VA National Acquisition Center Contract Catalog Search tool only Bristol-Myers Squibb Company is the only authorized distributor of this drug.

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(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted.

Market research was limited to the VA CCST pharmaceutical catalog search.

(7) Any Other Facts Supporting the Justification:

When procuring biological products, products must comply with FDA standards.

(8) A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made:

For all future buys, the CCST catalog will be searched to determine if other potential vendors exist.

(9) Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.

Angella Hannah Gillis AO Transplant Services

(10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Robert Pitre

CONTRACTING OFFICER/NCO 9

ANGELA HANNAH

GILLIS

Digitally signed by ANGELA

HANNAH GILLIS

Date: 2025.03.17 12:43:59 -05'00'

ROBERT PITRE Digitally signed by ROBERT PITRE Date: 2025.03.17 14:14:34 -05'00'

VHAPG Part 808.405-6 Limiting Sources Page 4 of 4 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C249-25-AP-1684

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $750K):

I certify the justification meets requirements for other than full and open competition.

Harry R. Grambo III Clinical Branch Chief, NCO 9