ATTACHMENT 4 - JA-FDB_Redacted.pdf

CUI - SOURCE SELECTION INFORMATION – SEE 2.101 AND 3.104

CUI

DEFENSE LOGISTICS AGENCY

DLA CONTRACTING SERVICES OFFICE - PHILADELPHIA

700 ROBBINS AVENUE

PHILADELPHIA, PENNSYLVANIA 19111-5092

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

Upon the basis of the following justification, I hereby approve the issuance of the contractual action described below using other than full and open competition, pursuant to the authority cited herein.

1. IDENTIFICATION OF THE REQUIRING AGENCY AND CONTRACTING

ACTIVITY

Agency Requiring Activity Defense Logistics Agency (DLA) Medical Directorate 700 Robbins Avenue Philadelphia, PA 19111

Contracting Activity DLA Contracting Services Office at Philadelphia (DCSO-P) 700 Robbins Avenue Philadelphia, PA 19111

2. NATURE AND/OR DESCRIPTION OF THE ACTION BEING APPROVED.

Pursuant to 10 U.S.C. 2304(c)(1) and Federal Acquisition Regulation (FAR) 6.302- 1(a)(2)(iii)(A), this justification and approval for other than full and open competition authorizes and approves the procurement of a sole-source/brand name pharmaceutical

Controlled by: DLA DCSO Philadelphia CUI Category: General Procurement and Acquisition / Source Selection Information see FAR 2.101 & 3.104 Distribution/Dissemination Controls: FED ONLY POC: Shannon.Collins@dla.mil / 215-737-2749 mailto:Shannon.Collins@dla.mil

Justification and Approval for Other than Full and Open Competition First Data Bank MEDKNOWLEDGE, Descriptive and Pricing Package

CUI - SOURCE SELECTION INFORMATION – SEE 2.101 AND 3.104

product classification license for use at DLA Troop Support Medical Directorate to support two-hundred-seventeen (217) Medical Master Catalog (MMC) user sites. The required license subscription and agreement is for the First Data Bank, Inc. (FDB) MEDKNOWLEDGE, Descriptive and Pricing Information.

The period of performance for this requirement will consist of a 12-month base period, and two 12-month option periods as follows:

Base Year: 06/01/2023 – 05/31/2024 Option Period One: 06/01/2024 – 05/31/2025 Option Period Two: 06/01/2025 – 05/31/2026

An award of a firm-fixed price contract is contemplated.

3. DESCRIPTION OF THE SUPPLIES OR SERVICES REQUIRED TO MEET

THE AGENCY’S NEEDS (INCLUDING THE ESTIMATED VALUE).

The DLA Troop Support Medical Directorate has a requirement to renew its existing data subscription license agreement for FDB MEDKNOWLEDGE Descriptive and Pricing Information. This license is required to provide DLA access to a drug database that includes descriptive drug information and classification in support of pharmacy procurement and analysis, which promises to lower healthcare costs and improve patient care. The database is required to provide critical classification data for DLA Troop Support on a weekly basis and enables cross references of products or equivalent products such as therapeutically equivalent products, pharmaceutically equivalent products, etc. FDB product information is also required in numerous DLA Troop Support Medical system applications as well as in downstream service customer systems and catalogs. The data subscription license agreement must cover the Government’s DODAACs that receive Medical Master Catalog (MMC) data that includes the FDB data feed.

The estimated dollar value for this procurement under a base year data subscription and two twelve-month option periods is .

Contract Period Period of Performance Base Period 06/01/2023 – 05/31/2024 Option Period 1 06/01/2024 – 05/31/2025 Option Period 2 06/01/2025 – 05/31/2026 Total

4. IDENTIFICATION OF THE STATUTORY AUTHORITY PERMITTING

OTHER THAN FULL AND OPEN COMPETITION.

The statutory authorities permitting other than full and open competition for this requirement are 10 U.S.C. 2304(c)(1) and FAR 6.302-1(a)(2)(iii)(A): The supplies or

CUI - SOURCE SELECTION INFORMATION – SEE 2.101 AND 3.104

services required by the requiring agency are available from only one or a limited number of responsible sources, and no other type of supplies or services will satisfy agency requirements. The services are deemed to be available only from the original source in the case of this follow-on medical/surgical product pricing data subscription contract for the continued provision of highly specialized data feeds, because it is likely that award to any other source would result in substantial duplication of cost to the Government that is not expected to be recovered through competition, due to higher reprogramming labor costs as well as the potential for higher data subscription costs.

5. DEMONSTRATION THAT THE PROPOSED CONTRACTOR’S UNIQUE

QUALIFICATIONS OR THE NATURE OF THE ACQUISITION REQUIRES

USE OF THE AUTHORITY CITED.

The follow-on nature of the requirement for renewal of the expiring pharmaceutical product classification license that comprises critical data feeds for DMLSS-W processes necessitates the use of the authority cited above. The logistics and acquisition communities rely on DMLSS-W system functionalities on a daily basis.

FDB owns various copyrighted databases. DLA Troop Support currently uses FDB’s MEDKNOWLEDGE, descriptive and pricing information package (formerly the National Drug Data File [NDDF] Package). The FDB MEDKNOWLEDGE, descriptive and pricing package combines drug descriptive and standard industry data information with an extensive array of clinical decision-support modules. It encompasses every drug approved by the FDA, plus information on over-the-counter (OTC) and alternative therapy agents such as herbals, nutraceuticals and dietary supplements. Based on the widely accepted industry standard, the FDB MEDKNOWLEDGE, descriptive and pricing databases are backed by the most clinically verifiable evidence gathered to date.

The following are a few of the most critical elements provided by the FDB data feed:

• The American Hospital Formulary Service (AHFS) therapeutic class code that identifies the pharmacologic therapeutic category of the product, where more than one AHFS code is possible, especially for combination products, is determined by FDB in consultation with the AHFS staff

• Dosage forms (e.g. Capsule – Soft, Hard, etc.)

• Drug Strength Description and Number for drug potency in metric units and volume, e.g. for gram, milligram, percentage, etc.

• Hierarchical Ingredient Code for active ingredient identification

• Hierarchical Therapeutic Class Code and Hierarchical Therapeutic Class

Description

• Generic Name and Generic Code Number Sequence Number

• DESI Drug Indicator for marking a particular drug as being declared less than effective by the Food and Drug Administration (FDA)

• Drug Class for availability to the consumer per Federal specifications

• Drug Form Code indicates the basic drug measurement unit for performing price calculations.

CUI - SOURCE SELECTION INFORMATION – SEE 2.101 AND 3.104

The classification data provides cross referencing of products or equivalent products such as therapeutically equivalent products, pharmaceutically equivalent products, etc. FDB product information is used in DLA Troop Support system applications as well as downstream Service customer systems and catalogs to research and compare available products to make clinical and purchasing decisions.

FDB’s classification system maintains greater capabilities for DoD than any other available source. Each DMLSS-DLA application would incur separate and time-consuming analyst and developer labor costs for redesign and recoding in order to incorporate a different file format, even if the decision was made to utilize a potentially sub-optimal competitor product. Reprogramming costs associated with implementation of another classification system are cost prohibitive and, even if invested, would not yield commensurate value to the Government. FDB provides extensive distributor information current systems can use while distributor information is either limited or unavailable from other sources and, FDB’s codes add value to the medical readiness posture by providing increased substitutability information. While other sources can provide similar data, their classification systems are incompatible with the system in place.

Currently, nor in the foreseeable future, the DMLSS-DLA program has no budget or business approvals to reengineer the existing data feeds.

Only FDB MEDKNOWLEDGE Descriptive and Pricing Information can provide the required drug databases that include descriptive drug information and classification in support of pharmacy procurement and analysis, which promises to lower healthcare costs and improve patient care.

6. DESCRIPTION OF EFFORTS MADE TO ENSURE THAT OFFERS ARE

SOLICITED FROM AS MANY POTENTIAL SOURCES AS IS

PRACTICABLE, INCLUDING WHETHER A NOTICE WAS OR WILL BE

PUBLICIZED AS REQUIRED BY SUBPART 5.2 AND, IF NOT, WHICH

EXCEPTION UNDER 5.202 APPLIES.

Based upon market research, (discussed in Section 8 below), it has been determined that only FDB MEDKNOWLEDGE Descriptive and Pricing Information can meet the Government’s requirement. The current action will be issued as a Combined Synopsys/Solicitation-Request for Proposal (RFP) posted to the Federal Business Opportunities website (https://beta.sam.gov/) in accordance with FAR 5.201(b). All responsible parties will be given an opportunity to submit an offer.

7. DETERMINATION BY THE CONTRACTING OFFICER THAT THE

ANTICIPATED COST TO THE GOVERNMENT WILL BE FAIR AND

REASONABLE.

As the Contracting Officer I hereby determine that proposed prices will be determined fair and reasonable, prior to award based on price analysis of the sole source proposal, that will be conducted in accordance with procedures detailed at FAR part 15.404-1. It is anticipated that the Government will use various price analysis techniques including but http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/05.htm#P56_9614 http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/05.htm#P67_10773

CUI - SOURCE SELECTION INFORMATION – SEE 2.101 AND 3.104

not limited to: (1) comparison of the proposal to prices previously paid to a third party contractor who was responsible for procuring the medical/surgical product pricing data feed during the Research and Development phase of MedPDB implementation, as well as a comparison to other raw data subscription providers, less data normalization and/or benchmarking services; (2) comparison to competitive published price lists (reference FAR 15.404-1(b)(2)(iv); (3) comparison of proposal to pricing obtained from market research for the same or similar items (reference FAR 15.404- 1(b)(2)(vi); (4) comparison of the proposal to historical prices paid, whether by the Government or other than the Government, for the same or similar items (FAR 15.404-1(b)(2)(ii)); and, (5) comparison of the proposal to the Independent Government Cost Estimate (FAR 15.404- 1(b)(2)(v)). All price analysis conducted will be in compliance with policy at FAR 15.404-1(a) to ensure that the final agreed-to price is fair and reasonable.

8. DESCRIPTION OF THE MARKET RESEARCH CONDUCTED (SEE PART

10) AND THE RESULTS OR A STATEMENT OF THE REASON MARKET

RESEARCH WAS NOT CONDUCTED.

The DLA Medical Directorate conducted Market Research to compare service offerings of the incumbent vendor (FDB) with alternative solutions existing in the industry.

Market Research techniques included a review of Acquisition History for contracts used by the directorate to procure similar services and researching the beta.SAM.gov and GSA websites for other vendors with similar data service offerings. Primary comparative factors used to analyze alternatives included technical service offerings, functional familiarity, and cost to the Medical Directorate.

Alternative subscription services considered included the Medi-Span Product and IQVIA (Formerly IMS).

Only one responsible source and no other supplies or services will satisfy agency requirements. The FDB data is deemed to be available only from the original source in the case of this follow-on pharmaceutical product classification license for the continued provision of highly specialized data feeds. It is likely that award to any other source would result in substantial duplication of cost to the Government that is not expected to be recovered through competition, due to higher reprogramming/reengineering labor costs as well as the potential for higher data subscription costs.

9. ANY OTHER FACTS SUPPORTING THE USE OF OTHER THAN FULL

AND OPEN COMPETITION

There are no budget or business approvals for reengineering the data feed.

10. LISTING OF THE SOURCES, IF ANY, THAT EXPRESSED, IN WRITING,

AN INTEREST IN THE ACQUISITION.

The following firm has expressed interest in this requirement FirstData Bank (FDB).

CUI - SOURCE SELECTION INFORMATION – SEE 2.101 AND 3.104

11. STATEMENT OF THE ACTIONS, IF ANY, THE AGENCY MAY TAKE TO

REMOVE OR OVERCOME ANY BARRIERS TO COMPETITION BEFORE

ANY SUBSEQUENT ACQUISITION FOR THE SUPPLIES OR SERVICES

REQUIRED.

At this time, FDB is the only IT product solution available on the market that will support DLA’s requirements and can meet the Government’s needs. However, DLA has exercised, and continues to exercise, competition as often as possible and is required to conduct ongoing market analysis to remain abreast of new technology, both in industry and the Government. As a continuing effort, DLA utilizes a variety of vendors, manufacturers, and contracts to fulfill its requirements and will continue the practice of surveying the market to ensure full and open competition to the maximum extent practicable.

12. CONTRACTING OFFICER CERTIFICATION THAT THE JUSTIFICATION

IS ACCURATE AND COMPLETE TO THE BEST OF THE CONTRACTING

OFFICER’S KNOWLEDGE AND BELIEF.

Technical and Requirements Certification I hereby certify that the supporting data provided for which I am responsible, and which forms the basis for this justification are complete and accurate:

I hereby certify that the information contained in this justification is accurate and complete to the best of my knowledge and belief.