JOFOC First Data Bank 2025_Redacted.pdf

JUSTIFICATION AND APPROVAL

FOR OTHER THAN

FULL AND OPEN COMPETITION

Acquisition Title: Enterprise License Agreement from First Data Bank, Inc to obtain pharmaceutical information used within healthcare information systems.

Acquisition Year: 2025

Author/COR: REDACTED

1. Description of Action:

Nature

☒New Requirement

☐ Follow-On Order

☐ Modification of Existing Purchase Order/Contract Number

Contract Type

☒Firm-Fixed Price

☐ Time and Materials

☐ Cost Plus Fixed Fee (CPFF)

☐ Term

☐ Completion

☐ Cost Plus Award Fee (CPAF)

☐ Other:

Name/Address of Proposed Contractor:

First Databank, Inc.

500 E 96th Street

Indianapolis, IN 46240

2. Description of Supplies or Services:

First Data Bank (FDB) is a publisher of pharmaceutical information used within healthcare information systems. FDB data includes a complete line of drug databases, including clinical decision support, disease suite modules, and stand-alone PC products.

This data also includes descriptive drug information, drug pricing, and drug identification. CMS uses the FDB files for intramural research and analysis projects as well as for the development of publicly available research products related to Medicare and Medicaid programs. These products include data files from First Data Bank (FDB):

• FDB Data Files

• Rx Norm Cross Reference Module

• NDDF Descriptive and Pricing

• Patient Education

☐ Basis for Approval (Far 6.303-1(d), FAR 6.302-1

☒Individual Basis

☐ Class Basis

Period if Performance (POP):

Projected Cost/Price:

Total: $1,823,601

Funding Source(s):

REDACTED

3. Authority and Rationale:

☒FAR 13.5 procedures in accordance with 41 U.S.C. 1901: Only one responsible source and no other supplies or services will satisfy agency requirements, First Data Bank, Inc. offers an unmatched range of tested and proven drug knowledge solutions designed to boost medical efficiency at the point of decision. This vendor provides information that is more intuitive, targeted, and actionable. The data provided by this service augments the value and impact of information technology systems.

First Data Bank is the only provider that meets the unique and critical data requirements to implement the Medicare Prescription Drug program for the following:

1. Exclusive Pricing Information for Drug Reimbursement

• First DataBank (FDB) contains Wholesale Actual Cost (WAC) pricing information that is not available through alternative sources like Medispan (MDDB)

• WAC pricing is the statutory basis for reimbursing selected drugs under Medicare Part D and is essential for the IRA-required drug price negotiation process

• This pricing data is critical for CMS's compliance with the Inflation Reduction Act mandates

2. Superior Clinical Classification Data

• FDB provides comprehensive clinical classification data with multiple classifications per drug, while MDDB only shows single classifications

• This multi-classification capability is essential for CMS Part D plan oversight, as regulations require plans to cover at least 2 drugs in each therapeutic class

Base Period Option Year 1 Option Year 2 Option Year 3 Option Year 4

$350,000.00 $357,210.00 $364,569 $372,079 $379,743 https://www.acquisition.gov/far/6.303-1?searchTerms=FAR%206.303-1(d)&FAR_6_303_1__d402e77 https://www.acquisition.gov/far/6.302-1

• CMS relies on this detailed classification data to analyze spending by drug class and ensure beneficiaries have adequate access to medications across all therapeutic categories

3. Data Quality and Reliability Advantages

• While MDDB may list NDCs earlier, FDB provides more finalized and reliable data with fewer revisions

• This reliability is crucial for the Drug Data Processing System (DDPS) to accept

Prescription Drug Events (PDEs) that would otherwise be rejected due to data inconsistencies.

• The combination of both systems allows CMS to identify new NDC codes early (via

MDDB) while maintaining data integrity (via FDB)

Critical DDPS System Dependencies

1. Schedule II Drug Enforcement (Edit Requirements)

• FDB is the primary source for identifying controlled substance schedules in DDPS

• This data is essential for enforcing DEA reporting requirements for Schedule II prescriptions, including original quantity prescribed reporting

• Given OIG audits of Schedule II drugs and DEA regulatory compliance requirements, this functionality cannot be compromised

2. Core System Validation

• DDPS requires drugs to be listed in either FDB or MDDB to be accepted for processing -this is a fundamental program requirement. FDB serves as the primary validation source for pharmaceutical data integrity

• If FDB was no longer available, major core system changes would be required.

3. Dispute Resolution and Fraud Prevention

• FDB dosage information is used alongside MDDB as a reference when FDA maximum daily dose data is unavailable

• This capability is essential for identifying potentially fraudulent or dangerous high-quantity prescriptions in PDE processing

☐ FAR 6.302-2: Unusual and compelling urgency, 41 U.S.C.253(c)(2)

☐ In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order or BPA must not have been previously issued under sole-source or limited sources procedures (FAR 8.405-6(a)(1)(i)(C)).

☐ An item peculiar to one manufacturer can be a particular brand name, product, or a feature of a product, peculiar to one manufacturer). A brand name item, whether available on one or more schedule contracts, is an item peculiar to one manufacturer. (FAR 8.405-

6(b).

4. A 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.

CMS published the notice required by FAR 5.201 on September 3, 2025 expressing

CMS’ intent to award a sole source purchase order for the required services and inviting interested parties to submit product information and pricing information sufficient for the

Government to evaluate whether the items could satisfy the Government's requirements.

5. Market Research:

To promote competition, CMS evaluated the open market searching for vendors that may offer this particular data and codes. CMS could not locate any other vendors. This data is only provided by First Data Bank and is relied upon by various systems and business stakeholders supporting the maintenance and delivery of the Medicare Advantage Part D

Prescription Drug program.

6. Any other facts supporting the use of other than full and open competition:

None

7. A listing of the sources, if any, that expressed, in writing, an interest in the acquisition:

None

8. A 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.

CMS will continue to monitor the market capabilities to determine if other sources become capable of providing the required information.

APPROVALS:

Program Office Certification: This is to certify that portions of this justification have been developed by the undersigned program office personnel, including supporting information and/or https://www.acquisition.gov/far/part-5#FAR_Subpart_5_2 https://www.acquisition.gov/far/part-5#FAR_5_202 data verifying the Government’s minimum needs, schedule requirements and other rationale, which form the basis for this Limited Source Justification.

Digitally signed by REDACTED

Date: 2025.09.12 07:09:47 -04'00'

Contracting Officer’s Representative (COR)/Date

Digitally signed by REDACTED

Date: 2025.09.12 08:24:36 -04'00'

Program/Project Manager (P/PM)/Date

Best Value Determination: By my signature below, after review of the relevant documents, I have determined that the order subject to this Justification represents the best value for the

Government as set forth in FAR 6.303- 2(b)(7) and constitutes a fair and reasonable price.

Contracting Officer Certification: This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief, the information and/or data provided to support the rationale and recommendation for approval, is accurate and complete.

By my signature below, after reviewing the relevant documents, I have determined that the order subject to this Justification represents the best value for the Government and constitutes a fair and reasonable price. The basis for my determination is as follows:

Price analysis in accordance with FAR 15.404-1 comparing proposed prices against previous contract prices for the same items.

Contracting Officer (CO)/Date

Digitally signed by

Date: 2025.09.12 10:22:51 -04'00'

1. CMS Competition Advocate Approval

I have reviewed this justification and find that it adequately supports other than full and open competition.

Name / Date

2. Head of Contracting Activity (HCA) Approval

I hereby confirm that the circumstances described above apply and approve this

Justification.

N/A

HCA Name / Date

3. Office of Small and Disadvantaged Business Utilization

4. OGC Legal Review

5. HHS Competition Advocate Approval

Digitally signed by REDACTED

Date: 2025.09.12 15:32:13 -04'00'

6. Senior Procurement Executive (SPE) Approval

Based on the foregoing justification, I hereby confirm the circumstances described above apply and approve the Justification.

SPE Name / Date