P03 JA Attach1 FAR 13.5 Sole Source Justification - Over SAT - 23AP0769_BC Signed_post_Redacted.pdf

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

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

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Pharmaceutical – Urgent and Compelling Award

Acquisition Plan Action ID: 36C77023AP0769

1. Contracting Activity: Department of Veterans Affairs, NCO 15 Contracting, Tucson CMOP, 2237:

762-23-3-040-2135, Tucson CMOP, Tucson, AZ

2. Nature and/or Description of the Action Being Processed: The CMOP facility in Tucson, AZ requires pharmaceutical Abaloparatide (NDC 70539-0001-02) to be procured with the support of the instant justification and approval for other than full and open competition to fulfill Veteran patient prescriptions. The proposed procurement action will be a new firm fixed-price contract award.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: This is an individual brand-name justification to support the emergency procurement of the following item:

a. Pharmaceutical: Abaloparatide 80mcg/0.04ml, 1.56ml Pen.

b. NDC #70539-0001-02

c. Quantity: 500

d. One-time delivery for Tucson CMOP, needed immediately

e. Estimated value:

f. No options

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:

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

( X ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

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

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

Unusual and compelling Urgency.

There are only two CMOPs that dispense this product for the entire United States, and Tucson CMOP supplies most of it. Tucson CMOP purchased this product from Prime Vendor McKesson in the past, but that option is no longer available. If Tucson CMOP is unable to fill an order for Abaloparatide, Veteran’s well-being could be adversely affected. IAW FAR 6.302(b)(2), a delay in award of this contract could result in serious injury to our Veterans.

This pharmaceutical, Abaloparatide, is prescribed by VA physicians for the treatment of postmenopausal women with osteoporosis and men with osteoporosis who are at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy. Tucson CMOP has indicated that demand for this product has recently increased significantly and therefore, they require this emergency order to ensure that Veteran prescriptions are filled as needed.

Radius Health Inc. is the only contractor that provides this pharmaceutical that is manufactured for them in Germany. Radius Health Inc. has a FSS contract for Abaloparatide but no longer distributes it themselves, rather they have two authorized distributors, one of which (Priority Healthcare Distribution Inc., dba Curascript Specialty Distribution) has provided this product to Tucson CMOP in recent past. Since the authorized distributors do not have an FSS contract, and the contract would be made directly to one of them, the Radius Health Inc. FSS contract cannot be utilized for the distributors.

Pharmaceuticals are 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.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A Sources Sought notice was posted on SAM.gov from 6/15/23 to 6/26/23 and no responses were received. The two Radius Health Inc. authorized distributors (Priority Healthcare Distribution Inc., dba Curascript Specialty Distribution (Curascript), a small business, and FFF Enterprises Inc. (FFF), a large business), were emailed a Request for Information. Both distributors responded with the same unit price and the same 1-day ARO. Additionally, historical data was obtained from VISTA IFCAP showing Curascript and FFF Enterprises Inc. are the only vendors that supplied this item from September 2020 through February 2023.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Curascript and FFF can provide this product immediately at the same price as Radius Health Inc.’s FSS contract (#36F79718D0363) price of per unit. The NAC CO determined

Effective Date: 02/01/2022 Page 3 of 4 the FSS contract price to be fair and reasonable. Additionally, the distributor’s unit price is within the historical unit price range listed in VISTA of , from September 2020 to February 2023.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted: Although the Veteran Small Business Certification (VetCert) site (https://veterans.certify.sba.bov) lists 129 SDVOSB/VOSBs under NAICS code 325412, there is only one contractor that supplies Abaloparatide (NDC 70539-0001-02) and they have 2 distributors, none of which are Veteran owned (one small business and 1 large businesses). Since this procurement is over SAT ($250K), and there are no known SDVOSB/VOSBs that can provide this product, the Rule-of-Two cannot be met.

This product is made in Germany for Radius Health Inc.; therefore, a Buy American Act VA Nonavailability Determination must be approved by the SAO and will be processed after the award of this emergency order.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: N/A

10. Listing of Sources that Expressed in May 2023, in Writing, an Interest in the Acquisition:

a. FFF Enterprises Inc., fffcustomercare@fffenerprises.com

b. Priority Healthcare Distribution Inc., dba Curascript Specialty Distribution, angela.liles@curascript.com

11. 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: Tucson CMOP is currently reviewing options for a longer-term contract but requires inventory immediately as they consider long term strategies.

12. 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.

Robert Emery Deputy Logistics Manager Tucson CMOP

ROBERT

EMERY

Digitally signed by

ROBERT EMERY

Date: 2023.07.11 11:59:04 -07'00'

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

13. 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.

Larry Zaritz Contracting Officer Network Contracting Office 15 - CMOP Division

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Christy Pendlay Branch Chief Network Contracting Office 15 - CMOP Division

LARRY ZARITZ

Digitally signed by LARRY

ZARITZ

Date: 2023.07.11 14:56:33 -05'00'

CHRISTY

PENDLAY

Digitally signed by CHRISTY

PENDLAY

Date: 2023.07.12 12:47:26 -05'00'