HHS JOFOC under FAR part 6__Fertility Initiative_Redacted.pdf

1. Assess fertility-related health outcomes and trends over time;

2. Identify clinical, demographic, geographic, and healthcare-utilization factors associated with infertility and other fertility-related conditions;

3. Evaluate the relationship between fertility-related conditions and chronic diseases, pregnancy complications, maternal morbidity and mortality, and other health outcomes;

4. Examine patterns in fertility assessment, diagnosis, treatment, and healthcare utilization;

5. Evaluate differences in access to fertility-related services and other relevant healthcare services;

6. Analyze maternal-infant-linked outcomes and longitudinal trends;

7. Identify opportunities for earlier recognition of fertility-related risks and underlying conditions;

8. Evaluate the effect of evidence-based interventions and healthcare practices using real-world clinical data; and

9. Provide analyses that may inform future HHS programs, research priorities, program planning, and policy development.

Performance of this requirement requires more than the delivery of a static commercial data file. The contractor must provide access to a sufficiently large historical and current healthcare dataset, maintain the source data and associated data infrastructure, apply data quality and validation processes, maintain continuity in variables and source systems across the required period of analysis, and provide technical and analytic expertise concerning the structure and appropriate use of the underlying data.

For this requirement, HHS requires a research data source capable of supporting analyses involving, at a minimum:

• inpatient, hospital-based outpatient, and emergency department encounters;

• longitudinal historical data sufficient to evaluate trends over multiple years;

• diagnosis and procedure information at a level sufficient to identify relevant fertility, reproductive, maternal, infant, and chronic health conditions;

• patient and encounter characteristics necessary to support appropriate stratification and analysis;

• healthcare utilization and treatment information;

• hospital and facility characteristics relevant to the analyses;

• sufficient volume and geographic breadth to support national-level and subgroup analyses;

• consistent data definitions, normalization, quality-control, and validation processes across the period under study; and

• the ability to obtain technical assistance and analytic support from personnel familiar with the provenance, structure, limitations, and appropriate interpretation of the data.

4. Statutory Authority Cited and Rationale:

a. FAR 6.103-1, Only one responsible source and no other supplies or services will satisfy agency requirements. Authority: 41 U.S.C. 3304(a)(1).

Based on market research conducted for this acquisition, HHS has determined that Premier Healthcare Solutions, Inc. is the only identified responsible source capable of satisfying the Government's independently defined minimum data and analytical requirements. The Premier Healthcare Database is the only data source identified through market research that provides the required combination of historical continuity, encounter types, data breadth, clinical and utilization variables, data-quality controls, recurring updates, and associated technical and analytical support.

The Premier Healthcare Database contains healthcare information furnished to Premier through its hospital and healthcare-system relationships and maintained within Premier’s proprietary data environment. According to information reviewed during market research, the PHD is the only research database that contains more than one billion patient encounters across inpatient and hospital-based outpatient settings and represents data supplied by more than 1,000 U.S. hospitals.

The Government’s need is not satisfied merely by obtaining access to any large commercial healthcare database. HHS requires the specific combination of historical continuity, encounter types, data structure, linked datasets, facility participation, clinical and utilization variables, and analytic capability necessary to perform the fertility-related analyses contemplated by this acquisition.

Premier is uniquely situated to satisfy this requirement for the following reasons:

First, proprietary control of the required source data. Premier owns, controls, or otherwise possesses the rights necessary to provide the Government with access to the PHD and its associated data environment. HHS’s market research did not identify another contractor authorized to provide the Government with the same research database, at the required level of completeness, directly or through an authorized reseller or other arrangement.

Second, historical continuity. The initiative requires analysis of trends over an extended period.

The PHD maintains historical data from 2008 – present, using Premier’s data collection, standardization, mapping, normalization, and quality-control methodologies. Substitution of an unrelated commercial dataset would result in a different hospital population, data lineage, variable definitions, coding practices, historical coverage, and methodology and therefore would not provide the same longitudinal dataset required for the contemplated analyses.

Third, integration of current and historical data. HHS requires continued access to historical information together with updated data to assess changes over time. Premier maintains the processes by which new source data are ingested, standardized, validated, and incorporated into the PHD. Another vendor could not independently update or recreate Premier’s proprietary historical database without access to Premier’s source feeds, data architecture, mappings, and underlying contractual/data-use rights.

Fourth, knowledge of the data’s provenance and limitations. Appropriate interpretation of real-world healthcare data requires detailed knowledge of source-system variation, data mapping, changes in participating facilities, coding practices, missingness, normalization, and other methodological limitations. Premier maintains the technical knowledge and documentation associated with its proprietary database and is therefore able to support appropriate use and interpretation of the PHD for this requirement.

Fifth, no equivalent source was identified through market research. HHS conducted market research, held discussions with industry, referenced similar requirements for historical acquisition methods, and publicized its intent to award on a sole-source basis to determine whether other responsible sources could satisfy the requirement. The Government specifically provided industry with an opportunity to submit information demonstrating an ability to meet the requirement. No healthcare data vendor or analytics contractor submitted a capability statement demonstrating access to the PHD or an alternate dataset satisfying all the Government’s stated minimum requirements.

The sole-source determination is therefore not based solely on Premier’s status as the incumbent contractor, convenience, familiarity with the requirement, or a preference for Premier’s products or services. Rather, the determination is based on Premier’s control of the required proprietary data source and the Government’s determination, following market research, that no other identified source can provide the combination of data access and related capabilities necessary to satisfy the Government’s minimum requirements.

Accordingly, HHS has determined that Premier Healthcare Solutions, Inc. is the only responsible source presently identified that can satisfy the Government’s requirements.

b. FAR 6.103-2, Unusual and compelling urgency. Authority: 41 U.S.C. 3304(a)(2).

Not applicable

c. FAR 6.103-3, Industrial mobilization; engineering, developmental, or research capability;

or expert services. Authority: 41 U.S.C. 3304(a)(3).

Not applicable

d. FAR 6.103-4, International Agreement. Authority: 41 U.S.C. 3304(a)(4).

Not applicable

e. FAR 6.103-5, Authorized or Required by Statute. Authority: 41 U.S.C. 3304(a)(5).

Not applicable

f. FAR 6.103-6, National Security. Authority: 41 U.S.C.

3304(a)(6). Not applicable

g. FAR 6.103-7, Public Interest. Authority: 41 U.S.C.

3304(a)(7). Not applicable

5. Special Considerations for Certain Contract Extensions or Bridge Contracts:

Not applicable. This action is for a new contract and is not being justified as a bridge contract or extension of the predecessor contract.

6. Actions to Increase Competition:

a. A Notice Was Published:

In accordance with applicable FAR Part 5 publicizing requirements, HHS published a Notice of Intent to Sole Source on SAM.gov from July 20, 2026, through July 27, 2026.

The notice advised industry of the Government’s contemplated sole-source acquisition and provided interested parties an opportunity to submit information or capability statements demonstrating their ability to satisfy the Government’s requirement.

b. Responses Were Received:

One communication was received during the notice period. On July 21, 2026, NITAAC Support contacted HHS regarding the potential availability of NIH Governmentwide Acquisition Contracts (GWACs) for the acquisition of information technology supplies and services.

c. Sources Expressing Interest:

NITAAC Support contacted HHS regarding the availability of the NIH GWAC program.

However, NITAAC did not represent itself as a prospective source capable of performing the underlying fertility-data requirement and did not identify a GWAC contractor possessing access to the required proprietary database.

No other source expressed written interest in fulfilling the requirement.

d. Actions to Foster Competition for Future, Similar Requirements:

HHS recognizes that reliance on a proprietary commercial healthcare database may limit competition when future requirements specify data or capabilities available only from the owner or authorized provider of that database. Before any subsequent acquisition for the same or similar requirement, the program office and contracting activity will reassess the Government’s minimum requirements and conduct market research to determine whether competition can be increased.

Subject to future programmatic requirements and available market capabilities, HHS anticipates considering the following actions:

1. Conduct market research early in the acquisition-planning process to identify new or expanded commercial healthcare databases, data aggregators, data-sharing arrangements, or analytic platforms that may satisfy HHS’s requirements.

2. HHS will reassess the market after the base year period and determine if there is a suitable contractor with the ability to complete the work. If sources are found, HHS will determine if a new competition is warranted. Prior to exercising each option, the Contracting Officer, in coordination with the program office, will assess whether the circumstances supporting this justification continue to exist and whether updated market information supports continued sole-source performance. If an alternative source capable of satisfying the Government's minimum requirements is identified and competition is practicable, HHS will evaluate whether a competitive acquisition should be initiated rather than continuing sole-source performance.

3. Issue a Sources Sought Notice or Request for Information sufficiently in advance of the next acquisition to obtain industry feedback regarding available datasets, data elements, historical coverage, facility representation, analytic capabilities, interoperability, and licensing arrangements.

4. Evaluate requirements on a capability-based rather than vendor-specific basis wherever practicable by defining the minimum required data elements, historical period, encounter types, update frequency, population coverage, analytic functionality, and data-quality characteristics without specifying a particular proprietary product unless the particular data source remains essential to the Government’s need.

5. Assess whether portions of the requirement can be separated so that functions not inherently dependent upon proprietary PHD access—such as certain analytic, visualization, program-management, methodological, or reporting functions—may be competed separately if doing so is technically feasible, economical, and in the Government’s best interest.

6. Evaluate alternative data sources to determine whether emerging commercial or Government datasets can provide sufficiently comparable information to satisfy future HHS objectives without requiring use of the PHD.

7. Consider data portability and Government-use requirements in future acquisition planning, where legally and commercially feasible, to reduce unnecessary dependence on a single contractor or proprietary analytic environment.

8. Document the results of future market research and reassess whether Premier remains the only responsible source before pursuing any subsequent noncompetitive acquisition.

These actions are intended to identify and, when practicable, reduce barriers to future competition. They do not presume that an alternative source will necessarily become available;

rather, HHS will reassess the marketplace and its minimum requirements before any subsequent acquisition.

7. Market Research:

Market research was conducted to determine whether commercial sources other than Premier could satisfy the Government’s minimum requirements for the HHS Fertility Data and Analysis Initiative.

The U.S. Department of Health and Human Services (HHS), Office on Women’s Health (OWH), requires access to current, regularly updated maternal and infant health data to support HHS efforts to improve maternal health and reduce preventable adverse outcomes. At a minimum, the data source must provide women’s health, maternal health, and linked birth data, standardized inpatient data, and hospital discharge data drawn from a representative hospital population. The data must support longitudinal analyses of inpatient health outcomes, including severe maternal morbidity and maternal mortality, and permit OWH to evaluate changes in those outcomes over time and assess the effects of interventions. These capabilities are necessary for HHS to identify opportunities for improvement, target resources, and improve maternal health care delivery.

OWH’s work is a longitudinal, multi-year initiative rather than a series of independent annual studies. Each year’s analysis builds upon the data mappings, cohort definitions, inclusion and exclusion criteria, validation procedures, analytic methods, benchmarks, and trend baselines established in prior years. Accordingly, continued access to the same underlying data source is required. Maintaining a consistent data source preserves comparability across reporting periods and enables OWH to distinguish actual changes in maternal morbidity and mortality from apparent changes caused by differences in hospital participation, data structures, coding practices, linkage methodologies, or population coverage.

After defining these minimum requirements, HHS considered whether another source could meet them and determined that only Premier can provide continued access to the underlying database on which OWH’s existing analytical framework and longitudinal baselines were established. A transition to another data source would require OWH to reconstruct and revalidate its data mappings, cohorts, methodologies, benchmarks, and historical baseline. Such a transition would introduce material discontinuities into the data and could prevent reliable interpretation of year-to-year trends. Therefore, only Premier can satisfy HHS’s minimum need for current maternal and infant health data while preserving the continuity and comparability required for the Initiative.

The program office reviewed the characteristics of the Premier Healthcare Database and considered whether other commercially available healthcare data sources or acquisition vehicles could provide the data and capabilities necessary to accomplish the requirement. The

Government also reviewed its prior procurement experience and published a Notice of Intent to Sole Source on SAM.gov to provide industry with an opportunity to identify alternative capable sources.

The PHD is a proprietary healthcare database maintained by Premier that contains a substantial volume of historical inpatient and hospital-based outpatient encounter data supplied through Premier’s relationships with participating U.S. hospitals and health systems. The database includes historical data and associated data standardization, validation, and quality-control processes that enable longitudinal analyses.

For purposes of the fertility initiative, HHS requires a data source possessing the following minimum characteristics:

• 10 years of historical data;

• inpatient, outpatient, and emergency-department encounter information;

• diagnosis and procedure information necessary to identify fertility-related and maternal health conditions;

• sufficient historical consistency to support longitudinal trend analyses;

• facility and patient characteristics required for the planned analyses;

• recurring/current data updates during contract performance;

• sufficient breadth and volume to support the intended national and subgroup analyses;

• established data-quality and validation procedures;

• documentation necessary to understand changes in source data and variables over time;

and

• technical and analytic support from personnel knowledgeable regarding the underlying dataset.

Market research did not identify another source capable of providing access to the same data or another source demonstrated to satisfy all the Government’s minimum requirements.

The Government further tested the marketplace by publishing its proposed sole-source action on SAM.gov from July 20, 2026, through July 27, 2026. No commercial healthcare data provider submitted a capability statement asserting that it could meet the requirement. The only response received was from NITAAC Support regarding the potential use of an NIH GWAC. That response addressed a contracting vehicle rather than the availability of an alternate source of the required healthcare data.

The Premier Healthcare Database (PHD) by Premier Inc. is a nationally representative, all-payer U.S. healthcare hospital database. The Database contains 25 percent of hospital data, including information on over one billion individual patient encounters across inpatient hospital discharges, outpatient clinics, and office visits. Covers diverse geographic regions, ages, genders, and payer types (commercial, Medicare, Medicaid, and self-pay). Tracks data across inpatient, outpatient, and ambulatory settings, including detailed medication and device utilization. Used widely for real-world evidence (RWE), health economics, outcomes research, and clinical surveillance.

The Government therefore determined, based upon the information presently available, that Premier is the only identified source capable of providing the required PHD access and associated services.

8. Procurement History:

New award

9. Additional Information or Other Facts:

Premier Healthcare Solutions, Inc. was awarded Contract No. 75P00122C00038 effective September 28, 2022, for services involving healthcare data and analytic capabilities similar to the current requirement. Prior to that award, HHS published a Notice of Intent on SAM.gov from July 12, 2022, through July 20, 2022. The acquisition was awarded on a sole-source basis pursuant to the applicable “only one responsible source” authority.

For the contemplated 2026 acquisition, HHS did not rely solely on the prior sole-source determination. The program office reevaluated the requirement and the availability of alternative sources. Current market research, including the July 2026 SAM.gov notice, did not identify another source capable of providing access to the type of data sets needed to fulfil the requirement nor with access to PHD data and its associated capabilities.

The Government’s determination is specifically tied to the requirements described in this justification. Premier’s incumbency, prior performance, familiarity with HHS, or the potential administrative burden of transitioning to another contractor are not independently relied upon as justification for the contemplated sole-source award.

The unique basis for the proposed award is Premier’s ability to provide the proprietary data source and associated data infrastructure required to satisfy HHS’s minimum needs, together with the absence of another identified responsible source capable of providing those requirements.

HHS will continue to monitor the commercial healthcare-data marketplace and will reassess available sources and alternatives before any subsequent acquisition.

10. Technical or Requirements Program Management Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

Supervisory Mgmt and Program Analys

Signature & Date:

11. Fair and Reasonable Price Determination: The Contracting Officer will determine the final negotiated price to be fair and reasonable prior to award. Because the contemplated acquisition will not benefit from price competition, the Contracting Officer will use appropriate proposal-analysis techniques and available pricing information to evaluate the proposed price.

Because the contemplated acquisition will not benefit from price competition, the Contracting Officer will use appropriate price-analysis and, when applicable, cost-analysis techniques to evaluate the proposed price. The analysis may include comparison with historical pricing under Contract No. 75P00122C00038, analysis of changes in scope and level of effort, comparison with applicable commercial pricing or sales information, evaluation of labor categories and rates where applicable, assessment of data licensing and subscription costs, and other information necessary to establish price reasonableness.

Award will not be made unless the Contracting Officer determines the negotiated price to be fair and reasonable.

This determination will be made using the following: ☐ cost analysis ☒ price analysis ☐ cost realism ☒ market pricing ☒ historical pricing ☐ other:

As a part of this basis, certified cost, or pricing data (see FAR 15.403)— ☐ will be required. ☒ will not be required and the following FAR part 15 exception applies:

☐ Prices that will be agreed upon are based on adequate price competition.

☐ Prices that will be agreed upon are based on prices set by law or regulation.

☒ A commercial service is being acquired.

☐ A waiver has been granted by the HCA in accordance with FAR 15.403-2(c)(4).

☐ The contract action is a modification to a contract or subcontract for commercial item(s).

☐ The estimated cost of the contract action is less than the threshold for certified cost or pricing data.

12. Contracting Officer (CO) Certification and Determination: I hereby certify that this justification is accurate and complete to the best of my knowledge and belief. And, based upon the foregoing, I also determine that using a sole-source contract is in the best interest of the government. (Always required; CO approval authority is limited to $900,000.)

Contracting Officer Signature & Date:

ELEVATED REVIEWS & APPROVALS

13. OMAS Advocate for Competition (AfC) Review and Approval: I reviewed this justification find that it adequately supports other than full and open competition. (Division AfC approval authority is limited to $20,000,000.)

Procurement Analyst Signature & Date:

14. OMAS Head of the Contracting Activity (HCA) Review and Approval: I reviewed this justification and find that it adequately supports other than full and open competition. (Division HCA approval authority is limited to $90,000,000.)

Head of the Contracting Activity Signature & Date: