A.02.04_Sole_Source_Justification_Redacted.pdf

For Official Use Only

(See FAR 2.101 and 3.104-4)

(25 February 2016)

Control Number: 18-RHCO-C 430

Sole Source Justification and Approval

Under FAR 13.501

1. Contracting Activity: Regional Health Contracting Office –Central, Joint Base

San Antonio- Fort Sam Houston, Texas.

2. Description of Action: Regional Health Contracting Office - Central intends to issue a sole source contract to Nevro Corporation for a Nevro Spinal Cord Stimulator

Implant that are surgically implanted to treat chronic pain resulting from trauma related injuries. These implant devices are used in the Department of Operative Services located at Brooke Army Medical Center located at San Antonio Military Medical Center

(SAMMC), Joint Base San Antonio, Fort Sam Houston, Texas. This action will be accomplished through the use of a Firm Fixed Price contract, utilizing Defense Health

Program Operation and Maintenance funds. The Period of Performance will be the date of award through 30 September 2018, with two (2) 12- month option periods.

3. Description of Supplies/Services: The following supplies are required: Nevro

Surgical Implants that will deliver a high frequency electrical pulse, and can be implanted in the lower spinal area for the treatment of back and leg pain. Total estimated for the base period is $959,750.00 for a period of performance of date of award to 30 September

2018, with two (2) option periods. Total estimated cost for base plus options is

$ 5,796,890.00.

4. Authority Cited: The statutory authority permitting other than full and open competition is 41 United States Code 1901 as implemented in FAR 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

5. Reason for Authority Cited: Nevro produces a permanent spinal cord stimulator system for treatment of chronic pain that is capable of stimulating the spinal cord at

10,000 Hz (HF-10). This specific wave-form frequency allows for non-paresthesia stimulation and is not reproducible by any other spinal cord system. The Nevro HF-10 system is currently supported for management of axial neck and back pain and has been studied extensively for control of such axial symptoms. Typical tonic stimulation frequently has been unable to obtain pain control of such regions making the Nevro HF-10 system superior for such pain etiology.

6. Efforts to Obtain Competition: A Sources Sought Notice was posted to

FedBizOpps on 30 March 2018 and closed on 11 April 2018. No interested sources responded.

Control Number: 18-RHCO-C 430 Nevro Surgical Implants

a. Effective competition. Nevro Corp is the only manufacturer of this spinal cord stimulator implant device that will deliver a high frequency electrical pulse of 10 kHz and can be implanted in the lower spinal area for the treatment of back and leg pain.

b. Subcontracting competition. FAR 19.702(b)(1) states that subcontracting plans are not required for small business concerns.

7. Actions to Increase Competition: As long as Nevro Corporation is sole manufacturer of this surgical implant device and does not have not have any authorized distributors, it is expected this requirement will continue to be solicited on a sole-source basis. However, the Government will continue to monitor the marketplace for any new entrants.

8. Market Research: Market research was conducted such as the SBA’s Dynamic

Small Business Search (DSBS) was reviewed to identify small business vendors and determined potential set-asides or subcontracting possibilities to provide Nevro

Surgical Implant devices for the Department of Operative Services, at San Antonio

Military Medical Center (SAMMC) Joint Base San Antonio, Fort Sam Houston, Texas.

The results revealed various firms but after a review of their profiles, none are able to provide an implant device with a high frequency electrical of 10 kHz. (Reference PCF files 01.01Market Research DSBS, Ability One, GSA and eLibrary).

9. Interested Sources: To date, no other sources have written to express an interest.

Notices required by FAR 5.201 shall be published and any bids or proposals received shall be considered.

10. Other Facts:

a. Procurement history.

(1) Contract numbers and dates of the last several contracts for these same requirements.

Contract Number: W81K00-18-P-0065 Contractor:

Nevro Corp.

Period of Performance: Base Year: $148,500.00

Control Number: 18-RHCO-C 430 Nevro Surgical Implants

Contract Number: W81K00-18-P-0096 Contractor: Nevro Corp.

Period of Performance: Base Year: $148,500.00

(2) Competitive Status of Actions: Procurement Method: Both of the above reference awards were Competitive

(3) Authority previously cited if less than full and open competition was used. Not applicable. Competitive simplified acquisition purchase orders with only one response.

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results. Not applicable

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources. See 7. Competitive simplified acquisition purchase orders with only one response. Further market research determined that there were no other companies that could fulfill the Government’s requirement.

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys. Not applicable

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes. Not applicable.

b. Other facts. Provide any other facts necessary to justify limiting competition that were not previously stated. None.

11. Technical Certification:

I certify 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.

Signature:

2018 Type

12. Requirements Certification: Include the following statement:

I certify 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.

Signature:

Typed Name

Nevro Surgical Implants

13. Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable.

14. Contracting Officer Certification:

I certify that this justification is accurate and complete to the best of my knowledge and belief. Digitally signed by

Nevro Surgical Implants

Approval

Based on the foregoing justification, I hereby approve the procurement of Nevro

Surgical Implants, total dollar $5,796,890.00 on an other than full and open competition basis pursuant to the authority of 41 U.S.C. 1901 as implemented by FAR 13.501, subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Signatur

Typed N