P03 ATTACH 2 - JA 808.405-6_Limiting_Sources_24Q0285_redacted.pdf

VHAPG Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT

Effective Date: 02/01/2022 Page 1 of 4

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C770-24-AP-0451

(1) Contracting Activity: Department of Veterans Affairs, NCO 15 Contracting, 3450 S. 4TH Street Trafficway, Leavenworth KS 66048. Purchase request 2237: 765-24-2-800-0117.

(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). This is a new requirement for Hines CMOP for a pharmaceutical (Levodopa 42mg Inhaler, NDC 10144-0342-60) that is only available through the manufacturer, Acorda Therapeutics Inc.

Order against: FSS Contract Number: 36F79723D0194

Name of Proposed Contractor: Acorda Therapeutics Inc.

Street Address: 420 Saw Mill River Road City, State, Zip: Ardsley, NY 10502 Phone: 914-326-5322

(3) Description of Supplies or Services:

The estimated value of the proposed action is

The below pharmaceutical is Brand specific and the manufacturer, Acorda Therapeutics Inc., is the only distributor. Acorda Therapeutics Inc. outsources the distribution of this product to Cencora aka ASD Healthcare (see P11 ACORDA DISCOUNT – DISTRIBUTORS EMAIL in the briefcase). This procurement is a one-time buy to be delivered to Hines CMOP. There are no options for this order.

Item: NDC: 10144-0342-60, Levodopa 42mg Inhalation Capsules Quantity: 684 boxes Each box contains 60 INBRIJA capsules (15 blister cards containing 4 capsules each) and one (1) INBRIJA inhaler

(4) Identify the Authority and Supporting

Effective Date: 02/01/2022 Page 2 of 4

FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

FAR 8.405-6(a)(1)(B): Only one source can provide the supplies required at the level of quality required because the supplies are unique or highly specialized; these items are Brand specific and only the manufacturer, Acorda Therapeutics Inc., distributes them. Acorda Therapeutics Inc. has a FSS Contract Number: 36F79723D0194 for this item.

Products have been prescribed for patients by VA Physicians. Pharmacy employees do not have the training and/or authority to countermand physician orders. “Brand Specific” products are the same thing as “dispense as written” on a physician’s prescription. No National Drug Code (NDC) substitutions are permitted. In the VA, Pharmacy Benefits Management (PBM) has determined that CMOP IDs in the National Drug File (NDF) will most always identify “Brand Specific” products in the “VA PRINT NAME.” The VA PRINT NAME is the official identifier of what the drug name should be. This along with the Product Code is how the facility identifies what drug they should dispense. This is not always inclusive where a particular NDC has been determined to be “formulation specific” by clinical evaluation performed by the PBM or in the case where only one product in the marketplace has been identified to contain the specific ingredients to match the product code.

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 the manufacturer, Acorda Therapeutics Inc., is the only distributor of these products

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:

The VA Pharmacist determine the needed prescriptions. There is an existing contract with the manufacturer (36F79723D0194) and there is no substitute item that will meet the facility needs. No competitions exist for this drug, and the NAC CO has determined the price to be fair

Effective Date: 02/01/2022 Page 3 of 4 and reasonable. This Federal Supply Schedule acquisition exceeds $250K (SAT) and IAW FAR 8.405-4, a price reduction request was sought resulting in no discounts are available (see P11 DISCOUNT – DISTRIBUTORS EMAIL in briefcase).

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted. A solicitation was posted on SAM.gov on 2/7/2022 for three business days resulting in no quotes. On 12/6/22, Acorda Therapeutics Inc. stated there are no authorized distributors. On 5/6/24, Acorda Therapeutics Inc. stated the only authorized distributor is Cencora aka ASD Healthcare, a large business, that is utilized to delivery product only. (See P11 DISCOUNT – DISTRIBUTORS EMAIL In the briefcase).

(7) Any Other Facts Supporting the Justification: N/A

(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: The medical center will purchase all pharmaceutical drug requirements competitively and fully utilize the prime vendor, national, and FSS contracts whenever possible. However, there are times that contracts sources do not have required drugs available and/or competition isn’t available. The Pharmacy Department will remove or overcome barriers to competition by adequately planning known requirements and pledges to do so before any subsequent acquisitions.

(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.

Justin M. Simon or Carlos Araghi Inventory Management Specialist Hines CMOP

CARLOS

ARAGHI

Digitally signed by

CARLOS ARAGHI

Date: 2024.05.08 10:50:57 -05'00'

Effective Date: 02/01/2022 Page 4 of 4

(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.

Brigitte Kidder Contracting Officer CMOP Division Network Contracting Office 15

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.

Justin Braden Smith Division Chief CMOP Division Network Contracting Office 15

BRIGITTE KIDDER

Digitally signed by BRIGITTE

KIDDER

Date: 2024.05.08 11:11:53 -05'00'

JUSTIN SMITH

Digitally signed by JUSTIN

SMITH

Date: 2024.05.08 12:45:55 -05'00'