JnA Sleep Implants 36C25524AP2008.pdf

36C255-24-AP-2008 Sleep Implants VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items

Request for Sole Source Justification >SAT-$7.5M under FAR13.5

Effective Date: 02/01/2022 Page 1 of 5

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C255-24-AP-2008

1. Contracting Activity:

Department of Veterans Affairs, VISN 15, Leavenworth, KS in support of Harry S. Truman Memorial Veterans’ Hospital (HSTMVH), Columbia, MO

2. Nature and/or Description of the Action Being Processed:

This procurement is to provide Sleep Implants, 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.

This will be a new Firm Fixed Price (FFP) Blanket Purchase Agreement (BPA) with Consignment Agreement.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

Requirements:

• Provide on hand stock of agreed upon consignment delivery of Inspire sleep system sets.

• Inventory on hand stock every quarter with COR and HSTMVH Implant Coordinator or Inventory Management Specialist.

• Support and training will need to be provided for surgeon implanting the device and this determination will be on the surgeon’s need.

• Support for training after implantation of device for the sleep lab physicians monitoring the patient’s compliance and tolerance of device.

• Support of third-party programs used to transmit data from device to a third-party program for physician or sleep lab tech’s review.

• Support of any failure or deficiencies of the device’s performance outside the expected performance of the device.

Consignment Agreement delivery

Request for Sole Source Justification >SAT-$7.5M under FAR13.5

Effective Date: 02/01/2022 Page 2 of 5

INSPIRE SYSTEM

2580/ INSPIRE SLEEP REMOTE including supporting equipment:

4063/ INSPIRE STIMULATION LEAD, 1/EA

4340/ INSPIRE RESPIRATORY SENSING LEAD, 1/EA

3028/ INSPIRE IMPLANTABLE PULSE GENERATOR, 1/EA

Base year

Option Year 1

Option Year 2 Option Year 3

TOTAL $ 1,730,200.80

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):

This Inspire implant is to provide an alternate method of treatment for sleep apnea. The standard of treatment has been continuous positive airway pressure (CPAP). However, patient compliance and meaningful treatment results have been an ongoing issue. Inspire is the only FDA approved implant therapy for the treatment of obstructive sleep apnea (OSA). The inspire implant directly stimulates the hypoglossal nerve stabilizing the throat during sleep to improve airflow and reduce obstructive sleep apnea events. This treatment is customizable to the patient and does not require masks or hoses traditionally associated with CPAP use. Due to this, patients will experience a significant reduction in sleep apnea events, OSA symptoms improvement and an overall reduction in snoring.

Inspire therapy is the only FDA-approved OSA therapy that works inside the body. A letter from Inspire is attached stating the preceding. There are no other implants that treats OSA.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

Market Research was performed and found no other sleep apnea implants or any other vendors for Inspire. Sources Soughts were held on SAM.gov (36C25524Q0308) and GSA (1689870), 04/11/2024- 04/19/2024 with no responses to either Sources Sought. Both Sources Sought used NAICS 339113 and included the Statement of Work.

Market Research will be performed before the exercise of each option to ensure that no other source could fulfill this requirement.

Request for Sole Source Justification >SAT-$7.5M under FAR13.5

Effective Date: 02/01/2022 Page 3 of 5

The Contracting Officer was provided a letter from Inspire Medical Systems stating the Lovell Government Services is their exclusive sole source distributor. Lovell Government Services is an

SDVOSB.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

The anticipated cost will be considered fair and reasonable, as the Independent Government Cost Estimate (IGCE) was formulated using Market Research of historical pricing and current price lists.

This is a commercial product. Certified cost or pricing data is not required.

The Program Office Subject Matter Experts (SMEs) have evaluated this product and found it acceptable.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

Inspire therapy is the only FDA-approved OSA therapy that works inside the body. A letter from Inspire is attached stating the preceding. There are no other implants that treats OSA.

Market Research was performed and only two businesses were found that provide these implants:

Inspire Medical Systems, a large business and Lovell Government Services, a SDVOSB. Lovell is the only vendor for Inspire.

A search of VetCert provided verification that Lovell is an SDVSOB.

The Contracting Officer emailed Lovell Government Services and asked where this product is manufactured. Lovell provided, via 07/17/2024 email, that these implants are manufactured in the

USA.

As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties.

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

N/A

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

No other sources expressed interest.

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:

Market Research will be performed befor the exercise of each option to identify any other source could fulfill this requirement.

08/27/2024