36C10G20D0001-009.pdf

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JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

6.302-5 -- Authorized or Required by Statute

1. Contracting Activity: Department of Veterans Affairs (VA) Office of Procurement, Acquisition and Logistics Strategic Acquisition Center 10300 Spotsylvania Avenue, Suite 400 Fredericksburg, VA 22408

2. Description of Action: The proposed action is for a firm-fixed-price (FFP) Indefinite Delivery Indefinite Quantity (IDIQ) contract to a single source, BioHorizon Implant Systems, INC. (BioHorizon), (Large Business Manufacturer and Distributor), 2300 Riverchase CTR Hoover, AL, 35244- 2808. Veterans Health Administration (VHA) has a need for dental implants based upon clinician’s determination of medical necessity for use during medical or surgical services and/or procedures at the Veterans Affairs Medical Centers (VAMCs) throughout the United States and its territories.

The objective is to streamline Veteran Affairs (VA) procurement of dental implants nationwide, ensure ease of availability, and to enhance the quality of the care VA provides to Veterans while maximizing efficiency and government buying power. The estimated value of this acquisition is $2,252,820.04 for a five year period with minimum guarantee of $2,500.

3. Description of Supplies: The proposed action is to acquire an array of dental implants, tools, and accessories as listed in table 1 below. BioHorizon is the sole manufacturer of BioHorizon brand dental implants. They have proprietary, trademarked dental implants which meet the minimum technical requirements (MTR) of this acquisition.

TABLE 1

DENTAL IMPLANTS AND ACCESSORIES

Healthcare Common Procedure Code System (HCPCS) –

Nomenclature Description

D6010 - ODONTICS ENDOSTEAL

IMPLANT

Implant specific fixture placed in bone

D6050 – TRANSOSTEAL IMPLANT Implant specific transmandibular fixture placed in bone

D6052* – ATTACHMENT ABUTMENT Manufactured attachment abutment to retain final prosthesis

D6055* – CONNECTING BAR Intraoral implant bar for final prosthesis support

D6056 - PREFABRICATED ABUTMENT Implant specific manufactured prefabricated abutment

D6057 - CUSTOM ABUTMENT Custom manufactured abutment DI106 - HEALING ABUTMENT Implant specific abutment for healing phase

DI107 - COVER SCREW Implant specific screw to cover implant fixture

DI108 – DRILL Implant specific drill for implant placement

DI115 - FIXTURE ANALOG Implant specific analog to replicate implant fixture

DI116 - ABUTMENT ANALOG Implant specific analog for prosthesis fabrication

DI117 - IMPRESSION COPING, PIN Implant specific impression coping for prosthesis fabrication

DI118 - LABORATORY SCREW Implant specific screw for prosthesis fabrication

DI119 - FIXTURE SCREW Implant specific screw to fit implant fixture

DI120 - ABUTMENT SCREW Implant specific screw to connect abutment to implant fixture

DI121 - OVERDENTURE ATTACHMENT

HOUSING

Attachment specific housing for overdenture retention

DI122 - PROTECTION CAP/ANALOG Implant specific protection cap/analog for prosthesis fabrication

DI123 - GUIDE PIN Implant specific guide pin for prosthesis fabrication

DI124* – ABUTMENT INSERTION GUIDE Custom fabricated guide for implant abutment placement

*INDICATES HCPCS CODES ADDED/NEEDED INCLUDING EXISTING

ADA DENTAL CODES

Consignment: Consignment Agreements will be used as an ordering method. Incorporated in each consignment shall be a statement that Medical Centers shall pay only for the " Dental Implants and/or ancillary items " that are used. As specified in “VHAPM Part 801.102 paragraph 3” definitions, a Consignment Agreement is an agreement for a specified period of time under which a Contractor provides an item to the Department of Veterans Affairs, reimbursement for which is made only if and when use of the item is made by the Department of Veteran Affairs. Unused items are returned to the Contractor at the end of the effective period of the agreement without reimbursement or other expense to the Government.

Direct Vendor Delivery (DVD): Under the “DVD” method, VAMCs may order product in advance of a scheduled surgery or purchase replacement inventory on an “as needed” basis. Under this method, all items are packaged for shipment to the delivery point cited on the purchase order as normal delivey, expedited, or a verbal order:

Normal Delivery: Normal Delivery is shipped in 2 days if ordered by 2PM Eastern Standard Time (EST). Normally called 2nd Day Air.

Expedited Delivery: Expedited Delivery is shipped next day if ordered by 2PM EST time.

Verbal Orders: In accordance with VHA Directive 1081.01, Prescribing Specialty Service personnel, any employees responsible for supporting the provision of care, to support a Prescribing Specialty Clinician, or to support administrative functions of an implanting Specialty Service, are authorized to verbally request delivery of dental implants or use of dental implants for routine, urgent, or emergency procedures directly from dental implant contract holders.

Rep Availability: The Contractor must have representatives available to cover the VA Facilities nationally. Representative must be available to provide additional support as needed by the clinicians.

Training: The Contractor must make available to the VA clinicians the same education material provided to their commercial customer e.g. practice materials/videos/manuals and frequency of training.

Technology Refresh: The contractor shall propose to the Government as stated below improved and/or replacement products within the contracted product line as appropriate new industry technologies emerge and/or products become obsolete during the term of the contract. “Improved items” are defined as items that have qualities that simplify or improve a previous version or contain new and/or emergent technology.

Further, the contractor shall ensure that all submissions offered are within scope and state-of-the-art. "State-of-the-art" is defined as the most recently designed components approved by the Food and Drug Administration (FDA) and are announced for marketing purposes. All improved and/or replacement products shall contain the manufacturer’s commercial warranty.

The contractor shall ensure that all improved and/or replacement products meet American with Disabilities Act (ADA) and Health Information Portability and Accountability Act (HIPAA) Federal requirements. The contractor shall ensure that all new submissions are approved in accordance with the pre-market notification under the FDA 510K process and labeled appropriately for dental implants.

The contractor shall submit the following information in writing to the CO, CS and COR for review and approval:

(1) A complete modification request form (provided by the CS after award) includes a list of specific contracted item(s) and/or new submissions to be added in the Attachment 3 - Excel Price-Cost Schedule;

(2) Product literature for the item(s) and a detailed description of the differences or benefits of products refreshed as compared to the item(s) being discontinued or added;

(3) Proper identification of any product requirements and/or procedures related to those product(s) proposed;

(4) FDA approval (if applicable);

(5) Provide historical sales to VA by item(s) (if applicable);

(6) Copy of commercial warranty and a Revised Product listing.

Additions: In addition to the dental implants that are included in the initial award, the Government may add dental Implants to the contract that meet the scope, outlined paragraph 3, and which are determined to have a fair and reasonable price. New additions will not be accepted during the 1st twelve months after contract award. The Contractor may request addition of new dental implants as outlined by the CO. The CO will make a scope determination prior to approving any modifications.

Upon receipt of a complete package as outlined above, the CO will review the proposed new addition product(s), and, as deemed appropriate, consult with clinicians, the Prosthetics Sensory Aid Service (PSAS), and the Project Management Office (PMO). In addition, the contractor may be asked to give an oral presentation to support its proposed new addition products. The CO will make a scope determination, and, if appropriate, approve the inclusion of the proposed new addition products into the contract.

If the proposed new addition product(s) are approved for inclusion in the contract, the CO will conduct price negotiations with the contractor, if deemed necessary, and make a fair and reasonable price determination. Once the price of the proposed new addition product(s) are determined to be fair and reasonable, the new product(s) will be added to the contract via a bilateral modification.

Administration of Additions: Any requested additions must be approved by the CO and PSAS before they may be offered under the contract.

Additionally, other than cost or pricing, data must be provided that supports the offered pricing. The items requested will go through the same evaluation procedures as items under the initial proposal evaluation. Approval of addition requests shall be implemented by issuance of a contract modification.

Deletions: At any time during the contract performance, the Government may elect to delete any item(s) at no cost to the Government. Also, at any point during contract performance the Contractor may submit a request to delete items from the contract based on the items being obsolete, unavailable, out of production or superseded. All deletions from the contract shall be at no cost to the Government.

This Independent Government Cost Estimate (IGCE) was derived from spend data from previous procurement history over a 5-year period from 2013 - 2017. The quantity and price for each HCPCS code was averaged using a weighted average with more weight being placed on 2017 data. The data was extrapolated based on dental implants ordered at all VA medical facilities. A 2.5% escalation rate was applied to each contract year following the first ordering period. The escalation rate is based on the medical care commodity Bureau of Labor Statistics 10 year average from 2007-2017.

Additionally, the final amount was increased by 30% to account for a number of factors including: new products being added the contract based on technological advances and expanded product lines, increase in the veteran population, and increase in spend for a Sole Source National Prosthetics contract. Based on this data, the IGCE for this effort is $2,252,820.04 for the five year ordering period. NOTE: The HCPCS represent a broad range of supply line items associated with each code.

4. Statutory Authority: The statutory authority permitting other than full and open competition is 38 U.S.C. § 8123 and 41 U.S.C. § 3304(a)(5), as implemented by 48 Code of Federal Regulation (C.F.R.), Federal Acquisition Regulation (FAR) § 6.302-5(a)(2)(i), Veterans Affairs Acquisition Regulation (VAAR) § 806.302-5(b)(1), and 41 U.S.C. 253(c)(5) Authorized by Statute. In accordance with 38 U.S.C. § 8123, the Secretary may procure prosthetic appliances and necessary services required in the fitting, supplying, and training and use of prosthetic appliances by purchase, manufacture, contract, or in such other manner as the Secretary may determine to be proper, without regard to any other provision of law”.

5. Rationale Supporting Use of Authority Cited Above: The cited authority ensures the nationwide availability and consistency of dental implants so that clinicians have the flexibility, upon consultation with patients, to order appropriate implants with minimal interruption to the provision of individualized patient care. A specific implant determination is based upon the clinician assessments of the individual patient's medical needs and anatomy.

As a result of the consultation between the clinician and patient, a determination is made as to the type and brand of implant required for favorable medical outcome of the patient. Clinicians also consider the patient level of comfort, preference, lifestyle, quality of life, and whether a dental implant has been implanted in another site. This decision is also based on the clinician’s training and experience utilizing the specified dental implants system.

This consultation is important as it reduces surgical and restorative risks and reduces implant failure risks. Based on a clinician's evaluation of patients' needs, the clinician or clinical team submits a request for brand name specific prosthetic implant that will achieve favorable treatment outcome for the individual patient. Every implant purchased from BioHorizon is based on the clinician's determination of the most clinically appropriate implant for the individual patient. BioHorizon provides and manufactures patented and/or trademarked implants that are unique to this company and are essential to patient care within VA. BioHorizon trademark prosthetic dental implants implants are proprietary and provided to the United States Government through direct sales. BioHorizon is the only source for BioHorizon specific brand dental implants and implant components and are manufactured to maintain strict compatibility with the BioHorizon manufactured dental implant restorative components. This BioHorizon manufacturing specificity is critical for a quality dental implant restoration and use of other non- BioHorizon produced components will void the manufacturers warranty.

6. Efforts to Obtain Competition: 38 U.S.C. § 8123 and 41 U.S.C. 253(c)(5) authorizes VA to obtain prosthetic appliances in such manner determined to be proper without regard to any other provision of law, including the full and open competition requirements of 41 U.S.C. § 3301, as implemented by FAR Part 6. Use of the authority conferred under 38 U.S.C. § 8123 streamlines VA’s procurement of dental implants nationwide and ensures the availability of state of the art dental implants for the nation’s Veterans. Accordingly, as authorized by 38 U.S.C. § 8123 and 41 U.S.C. § 3304(a)(5), it is appropriate to award this acquisition to BioHorizon, without regard to the competition requirements of 41 U.S.C. § 3301, as implemented by FAR Part 6. A notice of intent to sole source will be synopsized on the Government Point of Entry (GPE) at http://www.fedbizopps.gov. Any proposal received shall be consider and evaluated to determine if it is capable of meeting Agency needs.

7. Determination of Fair and Reasonable Cost: As the Contracting Officer, I hereby determine that the anticipated cost will be fair and reasonable and represent the best value to the Government. The anticipated cost are based on historical General Services Adminstration (GSA) Federal Supply Schedule (FSS) rates for items previously procured by the VA. However, pricing will be be evaluated in accordance with FAR 15.404-1(b)(ii) & (iv). The Government will compare the proposed prices to historical prices paid, whether by the Government or other than the Government, for the same or similar items, historical pricing of previous actions and comparable prices on the comparison with competitive published price lists. The contracting officer reserves the right to open discussions / hold negotiations with the contractor if its pricing are not determined to be fair and reasonable. Award will not be made unless a determination of fair and reasonable prices can be made.

8. Market Research: The goal is to obtain easily accessible, quality products, and volume based-discounts by establishing an enterprise–wide firm-fixed price (FPP) Indefinite Delivery Indefinite Quantity (IDIQ) for sole source contracts with the vendors that historically represent the highest spending and meet the goal of this requirement. Under the authority of 38 U.S.C. § 8123, “the Secretary may procure prosthetic appliances and necessary services required in the fitting, supplying, and training and use of prosthetic appliances by purchase, manufacture, contract, or in such other manner as the Secretary may determine to be proper, without regard to any other provision of law.”

The Strategic Acquisition Center will utilize this authority to establish BioHorizon as one of the five contractors awarded under this procurement..

BioHorizon’s patented, trademarked dental implants, are proprietary, and not available from another manufacturer in the commercial marketplace.

BioHorizon also does not authorize distributors of their products. A clinician 's decision to use a particular manufacturer's implant is based on the clinician 's determination of medical necessity, the experience of the clinician, and their expectation of specific treatment outcomes and patient care.

BioHorizon has been determined to be a responsible source with respect to performance. In addition, BioHorizon is certified in SAM with the NAICS code and Federal Awardee Performance and Integrity Information System (FAPIIS) was reviewed and FAPIIS shows no reports for BioHorizon that would indicate defective pricing, instances of contractor fault or recipient not-qualified, terminations for cause, default or material failure to comply, or non-responsibility of the contractor .

9. Other Facts: BioHorizon is only source for groundbreaking technologies such as MinerOss® allografts and xenografts, Grafton® DBM, AlloDermTM Regenerative Tissue Matrix (RTM), AlloDerm GBRTM Regenerative Tissue Matrix (RTM), Cytoplast® Dense PTFE Membrane, Mem-Lok® collagen and pericardium membranes, BioPlug and BioStrip. BioHorizon’s biologics products are scientifically proven for a wide range of soft and hard tissue applications. BioHorizon is also recongnized as a global leader for tissue regeneration solutions. BioHorizons offers a broad array of abutments for a wide range of restorative applications and individual needs including the versatile 3inOne abutment, the game-changing Laser-Lok abutments as well as the comprehensive Multi-unit abutment system.

Laser-Lok microchannels is a series of cell-sized circumferential channels that are precisely created using proprietary laser ablation technology. This technology produces extremely consistent microchannels that are optimally sized to attach and organize both osteoblasts and fibroblasts. The Laser-Lok microstructure also includes a repeating nanostructure that maximizes surface area and enables cell pseudopodia and collagen microfibrils to interdigitate with the Laser-Lok surface. With the success of BioHorizons Laser-Lok technology on implants, BioHorizons breaks new ground by applying this innovative technology to abutments. This enables our customers to use Laser-Lok abutments to create a biologic seal and Laser-Lok implants to establish superior osseointegration. Osseointegration refers to a direct structural and functional connection between ordered, living bone and the surface of a load-carrying implant. Currently, an implant is considered as osseointegrated when there is no progressive relative movement between the implant and the bone with which it has direct contact.

10. Listing of the Sources, if any that Expressed, in Writing, an Interest in the

Acquisition: The following table shows all Contractors who responded in writing. There were no Veteran-owned businesses that responded. Although Atlanta Dental responded and attended the Industry Day, they decided to not be part of this requirement since its manufacturer, Integrated Dental Systems, LLC (IDS) responded. IDS was not considered capable as they only provide replicas which did not meet the requirements since replicas would void warranties for the Veteran population with existing implants. Burbank Dental was determined not capable because they are a dental laboratory without the capability of supplying dental implants. Additionally, BurBank dental has an existing VA strategic national contract for its dental laboratory services.

Hiossen, Keystone Dental, Southern Implant and Preat Corporation are not being pursued since the VA historical spend with these companies was not significant enough to warrant a national strategic contract. It was determined by the technical subject matter experts and program office that we would not pursue vendor with historical 5-year spend less than $900,000. The SAC anticipates awarding a sole source IDIQ contract to Nobel Biocare, Dentsply, Zimmer Biomet, Biohorizon, and Straumann.

Contractor Bus Size Manufacturer (M) or Distributor (D)

Atlanta Dental Small (D) (IDS) Biohorizon Large M & D

BurBank Dental Small M Dentsply Large M

Hiossen Implant Small M Integrated Dental Systems Small M & D

Keystone Dental Large M Nobel Biocare Large M & D

Preat Corporation Small M & D Southern Implant SB (Manufacturer owned) D (Southern Implant)

Straumann Large Manufacturer owned D

Ziimmer Biomet Large M

11. Actions to Increase Competition: Currently, there are no actions that can be undertaken to increase competition. Clinicians have determined that BioHorizon’s dental implants are necessary to fulfill the Government’s requirement. The Government will continue to conduct market research to ascertain if there are changes in the market place which clinicians determine are acceptable to enable future actions to be competed.

12. Technical and Requirements Certification: I certify that the supporting data under my cognizance, which are included in this justification, are accurate and complete to the best of my knowledge and belief.

Signature: ______________________ Date: ______________________ Rodney Hicks Project Manager Prosthetic & Sensory Aids

13. Procuring Contracting Officer Certification: I hereby determine that the proposed contract action will represent the best value to the Government and certify that the justification is accurate and complete to the best of my knowledge and belief.

Signature: ______________________ Date:_________________ Antonio Ross Contracting Officer

Strategic Acquisition Center

14. One Level above Contracting Officer Certification: I hereby determine that the proposed contract action will represent the best value to the Government and certify that the justification is accurate and complete to the best of my knowledge and belief.

Signature: ______________________ Date:_________________ Brian Shepard Chief, Procurement Services Divison Strategic Acquisition Center

Rodney B Hickson 588545 Digitally signed by Rodney B Hickson 588545 Date: 2019.06.12 07:14:37 -04'00'

Antonio L. Ross 1049018 Digitally signed by Antonio L. Ross 1049018 Date: 2019.06.12 08:38:58 -04'00'

BRIAN J.

SHEPARD 303322

Digitally signed by BRIAN J.

SHEPARD 303322

Date: 2019.06.13 08:38:39 -04'00'

Approval

Based on the preceding justification, I hereby concur with the acquisition of Prosthetic Implants (Dental Implants) to BioHorizon in the estimated amount of $2,252,820.04.

Pursuant to the authority cited in 38 U.S.C. § 8123 and 41 U.S.C. § 3304(a)(5), as implemented by the FAR Subpart 6.302-5(a)(2)(i) and VAAR Subpart 806.302-5(b)(1), Authorized or Required by Statute, subject to availability of funds, and provided that the services and commodities herein described have otherwise been authorized for this acquisition.

Signature: _________________________________ Date: ____________

Donald Jones Competition Advocate Strategic Acquisition Center

6/17/2019

Tracking number DJ001

Jones, Donald

Digitally signed by Jones, Donald Date: 2019.06.17 15:26:54 -04'00'