S02_JnA_Q0132_Allsigned_.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

DEPARTMENT OF VETERANS AFFAIRS

Justification for “Brand Name” Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C770-24-AP-0139

1. Contracting Activity: Department of Veterans Affairs, NCO 15, National Contracting Office.

760-24-1-050-0252, Leavenworth CMOP, Leavenworth, KS

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

This is an individual brand name justification to support the procurement of one (1) Brand Name Specific Med/Surg item (INSULET, RESERVOIR, OMNIPOD 5 G6 (GEN5) 5CT, XL201) in the above table. The proposed procurement action will be a firm-fixed-priced contract.

Per the OEM, Omnipod provides non-stop insulin delivery through a tubeless, waterproof insulin pump called a Pod—all with no multiple daily injections. With SmartAdjust™ technology, Omnipod 5 uses your CGM value and trend to automatically increase, decrease, or pause insulin delivery every 5 minutes.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

Product has 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)/ or specific Manufacture Part Number (MPN) 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. 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.

4. Description of market research conducted and results or statement why it was not conducted:

The Consolidated Mail Outpatient Pharmacy (CMOP) has identified that this Med/Surg item is not available from mandatory sources (e.g., prime vendor) and, therefore, has submitted the acquisition to Network Contracting Office (NCO 15) which provides acquisition support to CMOP. This acquisition is for a medical surgical supply that has been specifically identified using the manufacture part number (MPN) and name. Since the (MPN) identifies the medical surgical item prescribed for the individual patient, market research must utilize (MPN) as the primary search criteria to ensure the correct product (i.e., Med/Surg) is purchased.

Medical Surgical items are not found on the National Institutes of Health (NIH) U.S. National Library of Medicine DailyMeds website.

In lieu of DailyMeds, searches begin by utilizing the VA image library – where the requested products manufacture/ OEM can be confirmed.

Once the OEM was confirmed, (OEM: Insulet) searches continue in VetCert and the SBA’s DSBS databases. First using the NAICS Code: 325413 and then more specifically, searching for the manufacturer/ OEM (Insulet).

i. VetCert, generated 86 SD/VOSB businesses using NAICS code: 325413.

ii. SBA’s DSBS, generated 18 Small businesses using NAICS code: 325413.

1. Both databases were checked for the manufacture/ OEM (Insulet) and the two searches yielded no results. Confirming that the manufacture, Insulet is not registered with VetCert or the SBA.

2. The business that did generate are distributors of large wholesalers.

SAM.gov was then searched to confirm the OEM/ manufacturer business size. Insulet, is registered within sam.gov and confirms they’re a large corporation, under the Certs and Reps section, of their registration.

Original Equipment Manufacturer (OEM) website: “Insulet Corporation” - Reviewed Product details https://www.insulet.com/ https://www.omnipod.com/what-is-omnipod

Cross-referencing the information with databases SAM.gov, the Small Business Administration’s VetCert, and/or other search engines (e.g., Google, U.S. Securities and Exchange Commission’s EDGAR), the manufacturers of the requested pharmaceutical(s) have been determined large business concerns.

The Contracting Officer reviewed the Non-Manufacturer Rule and its applicability to the procurement action. The nonmanufacturer rule applies to socioeconomic specific small business categories for contracts valued above the micro-purchase threshold, but does not apply to total (non-socioeconomic specific) small business set-asides below the SAT. In accordance with the Non-Manufacturer Rule as defined in 13 CFR 121.406(b), there are two or more small business concerns who identify themselves as authorized distributors. These small business concerns have 500 or less employees, engage in the retail wholesale trade and normally sell pharmaceuticals, take ownership or possession of the pharmaceutical via its facilities or via its personnel. However, market research concludes that there are presently no domestic small business concern manufacturers that exist in the commercial marketplace for the INSULET, RESERVOIR, OMNIPOD 5. The CO has confirmed there is no class waiver associated for the Med/Surg item INSULET, RESERVOIR, OMNIPOD 5 under NAICS Code: 325413. The Contracting Officer considered the use of an individual waiver, however, is not feasible due to the expedient nature of this acquisition. Given this information, a socioeconomic specific set-aside may not be feasible as vendors would not be able to comply with the NMR without a waiver of the fourth prong. Alternatively, a total small business set-aside is feasible as the NMR does not apply to total small business set-asides below the SAT.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Jennifer Knight Contract Specialist

J. Braden Smith Contracting Officer

Jennifer Knight Digitally signed by Jennifer Knight Date: 2024.01.16 09:30:27 -06'00'

JUSTIN SMITH Digitally signed by JUSTIN SMITH Date: 2024.01.16 10:35:48 -06'00'