Redacted FY26-0458 TAB C Justification and Approval (JA) under FAR Part 6 Hayes Renewal.pdf

CUI

Control Number: FY26-0458

Justification and Approval (J&A) for Other than Full and Open Competition

Federal Acquisition Regulation (FAR) Part 6

1. Identification of the Agency and Contracting Activity: Defense Health Agency (DHA), DHA

Contracting Activity (CA), Professional Services Contracting Division, (PS-CD).

2. Nature and/or Description of Action being Approved: Approval for this Justification and

Approval (J&A) is requested for a sole source action to purchase the Medical Technology Web-

Based Subscription from Winifred S. Hayes Inc (a Symplr company).

The Government intends to negotiate a Firm Fixed Price contract with the incumbent Winifred S.

Hayes Inc for this subscription renewal. The current contracts for Hayes subscription, HT001520C0009, expires on 28 February 2026.

3. Description of Supplies/Services and Estimated Value: Medical Benefits and Reimbursement

Branch (MB&R) request renewal of the Medical Technology Web-Based Subscription from

Winifred S. Hayes. This subscription is delivered via the web-based Hayes Knowledge Center database. Hayes has one of the largest proprietary web-based libraries of health technology assessments (HTAs) and genetic test evaluations (GTEs) in the United States, with a robust collection of topics, report types, and full-text reviews. Hayes is the only organization to offer the proprietary Hayes Ratings, the gold standard for evidence reviews. In order to develop program policy that allows beneficiaries to access new and emerging treatment, but does not expose them to untested, unsafe, or ineffective (unproven) treatment specifically excluded from coverage by TRICARE regulation, the DHA utilizes the following modules within the Hayes

Knowledge Center: Evidence Analysis; Precision Medicine; and Horizon Scanning:

Evidence Analysis – Includes HTAs with the Hayes Rating assigned, Research Briefs and Ad hoc Research Briefs that address a wide range of health technologies.

Precision Medicine – Offers research and analysis on genetic, genomic, and molecular testing and therapies, including Molecular Test Assessments, Clinical Utility Evaluations, Precision

Medicine Insights (GTEs), Precision Medicine Research Briefs, and Ad hoc Research Briefs.

Horizon Scanning – Addresses emerging and disruptive technologies with the potential for significant clinical, operational, or financial impact before they enter the market and tracks them through clinical trial development and the regulatory approval process.

Source Selection Information - See FAR 2.101 and 3.104-4

1 OCT 2024

Controlled by: Defense Health Agency (DHA) Controlled by: PS-CD

CUI Category(ies): Source Selection

Limited Dissemination Control: FED Only

POC: Peichang Wang: peichang.wang.civ@health.mil mailto:peichang.wang.civ@health.mil

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

OCT 2024

Period Period of Performance or Required Delivery Date

Estimated Value Type of Funding

Base Period 01 March 2026 – 28 February 2027 Operation & Maintenance

Option Period 1 01 March 2027 – 28 February 2028 Operation & Maintenance

Option Period 2 01 March 2028 – 28 February 2029 Operation & Maintenance

Option Period 3 01 March 2029 – 28 February 2030 Operation & Maintenance

Option Period 4 01 March 2030 – 28 February 2031 Operation & Maintenance

Total

4. Statutory Authority Permitting Other Than Full and Open Competition: 10 United States Code

(U.S.C.) 3204(a)(1) as implemented in FAR 6.103-1(b) Only one responsible source and no other supplies or services will satisfy agency requirements – “One responsible source.” DFARS

206.103-170 (a)(1)(i) “Following thorough technical evaluation, only one source is fully qualified to perform the proposed work.”

5. Rationale Justifying Use of Authority Cited: MB&R is responsible for ensuring TRICARE policy is based on current evidence, is responsive to changes in the standard of care in the U.S.

and complies with the laws and regulations governing TRICARE. MB&R develops program policy that allows beneficiaries to access new and emerging treatment, but does not expose them to untested, unsafe, or ineffective (unproven) treatment specifically excluded from coverage by

TRICARE regulation. This requirement is established by law and regulation. Care must be medically necessary and appropriate, and proven safe and effective.

Medical Technology Web-Based Subscription from Winifred S. Hayes is necessary to assist assessment of the safety and efficacy of new, emerging, and sometimes controversial health technologies and to meet its statutory obligation. Moreover, the Hayes HTAs include a Hayes proprietary rating process which is essential for MB&R medical benefit determinations, which recommend whether a treatment is proven or unproven (i.e., Evidence Analysis - HTAs). This well-defined rating conclusion on whether the treatment is the standard of care or experimental closely aligns with TRICARE regulation set in 32 CFR 199.2.

The Hayes subscription is an enterprise-wide tool, relied upon by several other DHA offices including: Appeals, Hearings and Claims Collection Division; Clinical Support Division, Medical Affairs; Laboratory Joint Working Group; and the Office of Inspector General. If Hayes subscription is not renewed for MB&R, MB&R will lose the ability to collaborate with other

DHA offices, and the fallout will impact DHA’s ability to make timely decisions regarding new medical benefits for its 9.5 million beneficiaries.

After conducting discussions with representatives of Winifred S. Hayes, it’s discovered that

Winifred S. Hayes is part of Symplr. In addition, the Hayes subscription is a proprietary product for Hayes, and it’s not available through resellers. Furthermore, according to market research

(See Sections 6 and 8), there is “no equivalent” product that can replace Medical Technology

Web-Based Subscription from Winifred S. Hayes.

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

6. Efforts to Obtain Competition: In order the assess the commercial market for alternatives to the Hayes subscription, a Request for Information (RFI) was posted on SAM.Gov on 10 July

2025 for “Evolving Medical Practices Web-Based Subscription Service” with detailed functional requirements listed in the “Description” section. To ensure maximum exposure and sufficient response time, this RFI was posted full and open to all contractors, no reference to Hayes or

Hayes technology was made, and response due date was 15 August 2025, which gave any potential interested party more than 30 days to respond. By RFI closing date and time, no vendor expressed interest in this opportunity. Furthermore, Contracting did not receive any email requesting additional information or clarifications. There is no interest in the market for

“Evolving Medical Practices Web-Based Subscription Service.”

7. Actions to Increase Competition/Remove or Overcome any Barriers to Competition: With evolving mission requirements and an environment of rapidly changing technology, DHA’s need for Medical Technology Web-Based Subscription will not remain the same. MB&R and application super-users are actively assessing this technology against real time DHA needs to evaluate if and when it needs to be replaced. Furthermore, attention will be paid to technologies that have broader commercial market presence and can be competed among multiple offerors.

8. Market Research: In accordance with FAR Part 10, market research was conducted from 01

February 2025 to 15 August 2025 to assess the potential of competing this requirement. To ensure all possible options are explored, a two-prong strategy was adopted for this market research. One approach was posting a RFI on SAM.Gov (See Section 6 for details); by closing date and time, the RFI did not generate any interest in the marketplace. The other approach was discussing potential alternatives with DHA super-users of this subscription service. Given their familiarity with this type of technology, the super-users were identified as the subject matter experts (SME) with sufficient technical expertise and knowledge of this particular field of technology to know or identify similar or equivalent technologies. By 28 May 2025, feedback from SME provided two (2) options:

1) DHA to develop its own internal Government application to replace existing Hayes

Subscription: considering limited resources (funding, knowledge, time, personnel etc.), this is more of a theoretical option.

2) Discuss with Symplr, which has similar technology: during discussion with Winifred S.

Hayes, it’s discovered that Winifred S. Hayes is part of Symplr; so Hayes technology is

Symplr technology.

After exhaustive market research, it’s determined that only Winifred S. Hayes can provide the type of Medical Technology Web-Based Subscription that meets the requirements of MB&R.

9. Other Facts:

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

a. Procurement History:

(1) Is this a new requirement? No.

(2) If 9.a.(1) is No, was the action just prior to this one competed? No.

(3) If 9.a.(2) is Yes, what has changed where this action cannot be competed? N/A.

b. Additional Information: N/A.

10. Interested Sources: Winifred S. Hayes (a Symplr company)

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

11. Technical Certification:

I certify the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Healthcare Policy Analyst

Medical Benefits and Reimbursement Branch (MB&R)

Defense Health Agency

12. Requirements Certification:

I certify the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Healthcare Policy Analyst

Medical Benefits and Reimbursement Branch (MB&R)

13. Fair and Reasonable Cost Determination:

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

Basis for Determination: The Contracting Officer will determine that the anticipated cost to the

Government will be fair and reasonable through a comparison and analysis of proposed prices with historical prices paid, the Contractor’s list prices, the Independent Government Cost

Estimate.

Contracting Officer

Professional Services – Contract Division (PS-CD)

14. Legal Review:

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

I have reviewed this justification and have found it to be legally sufficient.

Associate General Counsel

Office of General Counsel

15. Contracting Officer Certification:

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

Review

I have reviewed this justification and find it adequate to support other than full and open competition.

Concurrence

Chief, Contracting Office

Approval

Based on the foregoing justification, I hereby approve the procurement of renewal of Medical

Technology Web-Based Subscription from Winifred S. Hayes in the amount of on an other than full and open competition basis pursuant to the authority of 10 United States Code

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

(U.S.C.) 3204(a)(1) as implemented in FAR 6.103-1(b) Only one responsible source and no other supplies or services will satisfy agency requirements – “One responsible source” and DFARS

206.103-170 (a)(1)(i) “Following thorough technical evaluation, only one source is fully qualified to perform the proposed work,” subject to availability of funds, and provided that the supplies and/or services herein described have otherwise been authorized for acquisition.

Professional Services – Contracting Division (PS-CD)