S02_JandA_Q0268_allsigned_.pdf

Combined order for stations (763 & 761)

36C770-24-AP-0537 & 763-24-2-021-0823 | 36C770-24-AP-0591 & 761-24-3-014-0241

Omnipods Reservoir’s 36C77024Q0268 – Knight/McAlhaney

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

Last Updated: 02/01/22

DEPARTMENT OF VETERANS AFFAIRS

BRAND NAME JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR

CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C770-24-AP-0537 & 36C770-24-AP-0591

1. Contracting Activity: The Department of Veterans Affairs, NCO 15 – CMOP Division - Contracting Office will be procuring this acquisition for 1600 packages (PG) of Insulet Omnipod Reservoir G6 (Gen5). Contracting office will utilize 2237 # 763-24-2-021-0823 & 761-24-3-014-0241 for the replenishment of low stock levels at the (763) Lancaster (1000 units) & (761) Chelmsford (600 units), CMOPs.

2. Nature and/or Description of the Action Being Processed: This procurement is for one

(1) medical surgical supplies (med/surg) (Insulet Reservoir Omnipod 5, G6) in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR

13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. The proposed procurement action will be a new firm-fixed-price contract.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: This is an individual brand name justification to support the procurement of the one (1) medical surgical items listed in the below table. The Lancaster CMOP will receive a monthly delivery over a four (4) months period, with the first delivery, 10 days after receipt of order. Chelmsford’s will be a one-time delivery - 10 days after receipt of order.

From OEM: "Omnipod tubeless systems are made of two main components, the Pod and a smartphone-like Controller. The pod is a small device that you fill with insulin and wear directly on your body. The Pod receives insulin delivery instructions from the Controller. It then delivers insulin into your body through a small, flexible tube called a cannula".

Item Number

IMFN CMOP

LOCATION

Description

MANUFACTURER

PART NUMBER

(MPN)

Quantity Unit of Measure

Packaging Multiple

Delivery Date

Special Instructions

ITEM PART

NUMBER

OEM

NAME

0001 19387 VA CMOP Lancaster - 763 RESERVOIR,OMNIPOD 5 G6 (GEN5) 5CT, XL201 08508-3000-21 1000 BX 5 FIRST DELIVERY:

10 Days ARO

Delivery: Will be Monthly.

250 Boxes each month, over a 4 months. Specific Dates will be laid out in the contract.

08508-3000-21 INSULET

CORPORATION

0002 19387 VA CMOP Chelmsford - 761 RESERVOIR,OMNIPOD 5 G6 (GEN5) 5CT, XL201 08508-3000-21 600 BX 5 10 DAYS ARO 08508-3000-21

INSULET

CORPORATION

Omnipods Reservoir’s 36C77024Q0268 – Knight/McAlhaney

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

Last Updated: 02/01/22

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement.

Competition is restricted on this procurement for the reason below:

(X) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the

Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

Products have been prescribed for patients by VA physicians. Pharmacy employees do not have the training and/ or authority to countermand physician’s orders. “Brand Specific” products are the same thing as “dispense as written” on a physician’s prescription. No Manufacture Part Number (MPN) substitutions are permitted. In the VA, Pharmacy Benefits Management (PBM) has determined that CMOP IDs in the Manufacturer Part Number (MPN) will 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 or work in coordination with brand name, medical surgical equipment.

Line-Item: 1 – Reservoir, Omnipod 5 G6 | Local Stock Number/ MPN#: 08508-3000-21|

Omnipods Reservoir’s 36C77024Q0268 – Knight/McAlhaney

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

Last Updated: 02/01/22

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A sources sought notice was not posted for this acquisition because Med/Surge buys are routine, and the Contracting Officer is very knowledgeable about the Med/Surg marketplace. It is unlikely that a sources sought notice would produce significantly new information about the market. Therefore, a competitive solicitation will be posted to the Government point of entry at SAM.gov to provide public knowledge of VA’s requirement. Only qualified vendors will be able to submit quotes due to the Gray Market/Brand Name only, OEM requirements.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Contracting Officer anticipates cost of award will be fair and reasonable based on competition, the Independent Cost Government Estimate (IGCE), and previous acquisition cost history for the same requirements.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: In accordance with FAR Part 10 and VAAR 810 market research was conducted on 5/03/2024 for the upcoming acquisition:

Omnipods - Insulet Reservoir Omnipod 5, G6. A sources sought notice was not posted for this acquisition because pharmaceutical/ Medical Surgical buys are routine, and the Contracting Officer is very knowledgeable about the pharmaceutical/ Medical Surgical marketplace. It is unlikely that a sources sought notice would produce significantly new information about the market. Therefore, a competitive solicitation will be posted to the Government point of entry at SAM.gov to provide public knowledge of VA’s requirement.

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

National Library of Medicine DailyMeds website.

a. In lieu of DailyMeds, search began by utilizing the VA image library – where the requested product (IMFN), manufacturer/ Original Equipment Manufacturer (OEM) can be confirmed.

The Item Master File Number (19387) was then used to query VISTA – in order to review past procurement history. PO: 760-A40090 | RFQ:

36C77024Q0233| CONTRACT: 36C77024P0241 & PO: 760-A40063

|RFQ:36C77024Q0181 | Contract: 36C77024P0201 were reviewed, were all quotes received, listed product as USA Made, by the sole manufacturer - INSULET CORPORATION

Omnipods Reservoir’s 36C77024Q0268 – Knight/McAlhaney

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items

Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

Last Updated: 02/01/22

Once the OEM was confirmed, (OEM: INSULET CORPORATION) searches continue in VetCert database. First using the NAICS Code:

325413 and then more specifically, searching for the manufacturer/

OEM (INSULET CORPORATION).

VetCert, https://veterans.certify.sba.gov/#home - generated 89 SD/VOSB businesses using NAICS code: 325413 database was checked for the manufacturer/ OEM (INSULET CORPORATION) and yielded no results.

Confirming that the manufacture, Insulet is not registered with VetCert.

The businesses that did generate are distributors of large wholesalers.

b. The following databases/websites were queried to identify manufacturers/packagers and domestic availability of the required Medical Surgical items.

SAM.gov – o OEM was searched on https://sam.gov/content/home o OEM, Insulet Corporation is registered and active.

o OEM confirms they are a large business.

Federal Procurement Data System (FPDS) https://www.fpds.gov/fpdsng_cms/index o Past procurements were reviewed.

o Past procurements confirmed that item is made in the USA.

SBA – DSBS

o https://dsbs.sba.gov/search/dsp_dsbs.cfm o 22 Vendors generated as doing business with NACIS Code:

325413, with Keyword: Manufacturing.

o Vendor Specific OEM (Insulet Corporation) did not generate on the SBA/DSBS website. Confirming that the manufacture, Insulet is not registered with SBA.

NAC – National Acquisition Center (CCST) o https://www.vendorportal.ecms.va.gov/NAC/Search o Searched the product on the MedSurg Catalog.

This yielded no results.

o Searched the product on the pharmaceutical catalog.

This yielded the Omnipod 4 Dash product. The requested Omnipod 5, is not on the NAC.

Original Equipment Manufacturer (OEM) website (Insulet

Corporation) o https://www.insulet.com/ o https://www.omnipod.com/ o https://www.omnipod.com/current-podders/resources/omnipod-5 Product information -what it does.

Omnipod® gives you more with less.

Omnipod provides non-stop insulin delivery through a tubeless, waterproof* insulin pump called a Pod—all with no multiple daily injections. Get up to 3 days (72 hours) of continuous insulin delivery and freedom with these innovative features:

Omnipod tubeless delivers insulin into your body through a small, flexible tube called a cannula.

Reservoir, Omnipod 5 G6 | Local Stock Number: 08508-3000-21|

The Pod and Dexcom G6 CGM are in constant communication, enabling automatic insulin adjustments to help protect against highs and lows.1,2 And, you can control it all from your fingertips with the Omnipod 5 App on a compatible smartphone. With SmartAdjust™ technology, Omnipod 5 uses your CGM value and trend to automatically increase, decrease, or pause insulin delivery every 5 minutes.

Omnipods Reservoir’s 36C77024Q0268 – Knight/McAlhaney

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

Last Updated: 02/01/22

Dun & Bradstreet (D&B) website: https://riskanalytics.dnb.com/en- US/login o Company size information 3000 employees

EDGAR- OEM Search https://www.sec.gov/edgar/searchedgar/companysearch o OEM is listed on EDGAR.

c. The Nonmanufacturer Rule The Contracting Officer reviewed the Non-Manufacturer Rule.

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 businesses 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 small business manufacturers that exist in the commercial marketplace. The CO has confirmed there is no class waiver associated for Medical Surgical Supplies 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. A small business set-aside is not feasible as a small business would not be able to comply with the NMR since there are presently no small business manufacturers.

9. Discuss consideration to BAATAA/Exception to BAA (See FAR Part 25) The sole item is Brand Name only. Per FAR 25.01(a)(5) the use of the sole source justification for brand name only - is an exception to the use of trade agreements. Therefore, BAA applies. However, market research and past procurement history indicates that the requested item is made in the USA and will not require a BAA waiver.

10. Any Other Facts Supporting the Use of Other than Full and Open Competition:

Previous acquisition history with this VA contracting office has shown a mix of large and small businesses have met and fulfilled this product in the recent past.

Omnipods Reservoir’s 36C77024Q0268 – Knight/McAlhaney

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

Last Updated: 02/01/22

11. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Market research shows both large and small business have provided this product in the past to various CMOP locations.

12. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: No action is being taken at this time due to the fact that no MPN substitutions are permitted based on physician’s specific orders.

13. 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 and belief.

Jennifer Knight Contract Specialist Network Contracting Office 15 – CMOP Division

Joseph Sousa Inventory Management Specialist Chelmsford CMOP

Tronny McCoggle Inventory Technician Lancaster CMOP

Jennifer Knight Digitally signed by Jennifer Knight Date: 2024.05.07 13:19:53 -05'00'

JOSEPH SOUSA Digitally signed by JOSEPH SOUSA Date: 2024.05.07 14:41:24 -04'00'

TRONNY

MCCOGGLE

Digitally signed by TRONNY

MCCOGGLE

Date: 2024.05.07 15:23:44 -05'00'

14. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

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

Michael McAlhaney Contracting Officer

J. Braden Smith Branch/Division Chief

MICHAEL MCALHANEY Digitally signed by MICHAEL MCALHANEY Date: 2024.05.09 07:13:29 -05'00'

JUSTIN SMITH Digitally signed by JUSTIN SMITH Date: 2024.05.10 08:47:30 -05'00'