RFI.docx

HHS Request for Information on All-Payer Claims Analytic Support for Drug Safety, Patient Safety, and Program Integrity AGENCY: U.S. Department of Health and Human Services (HHS or the Department) PURPOSE: This RFI is issued solely for market research and acquisition planning purposes and does not constitute a solicitation, request for proposal, request for quotation, invitation for bid, or commitment by the Government to award a contract. Responses will not be considered offers and cannot be accepted by the Government to form a binding contract. The Government will not reimburse respondents for costs associated with preparing or submitting a response. HHS may use information received to refine the requirement, acquisition strategy, market research, or a future solicitation. The Government is not obligated to acknowledge receipt of responses or provide feedback to respondents.

DATES: Responses to this notice must be received by Tuesday, October 20, 2026, at 12:00 PM ET.

CONTEMPLATED CONTRACT: The Government contemplates one firm-fixed price contract for one 12-month base period and one 12-month option period. All analytic work will be performed on de-identified data the contractor holds. The contractor would not take custody of HHS-held or CMS-held data. No Government data would be ingested. No Government information system would be accessed, operated, or maintained by the contractor on the Government’s behalf.

The contractor would return written analyses stating what was found, how it was found, and what the analysis does and does not establish. HHS retains responsibility for any investigation, validation, determination, or enforcement action.

BACKGROUND: HHS oversees federal health programs and the providers and facilities that bill them. Claims data can show how a category of care is delivered across payers and can surface billing patterns that merit review. HHS requires real-world evidence for post-market drug safety evaluation and analytic support for program-integrity questions.

HHS is particularly interested in understanding the availability and characteristics of contractor-owned, de-identified all-payer claims data; the maturity of associated analytical environments; the ability to conduct longitudinal and cross-payer analyses; approaches to methodological reproducibility and validation; and industry capabilities to perform the work described.

This effort is an expansion of predecessor work under contracts 75P00124P00074 and 75P00124P00056. HHS has no right, title, or license in the underlying licensed claims data from which the predecessor effort was produced. The questions below ask respondents to confirm whether their existing data, methods, and readiness can support methodological comparability with the predecessor effort and the contemplated delivery schedule.

The draft SOW currently contemplates a de-identified, all-payer claims environment integrating medical, facility, and pharmacy claims from commercial, Medicaid, Medicare, Medicare Advantage, VA, Tricare, and other payers; covering all 50 states; providing longitudinal history from 2015 forward; including more than 300 million unique de-identified lives, approximately 5 billion transactions per year, and more than 700 billion records; and supporting regular refreshes for near-current visibility. Respondents should identify whether they can meet these characteristics and, if not, describe alternative data characteristics or approaches that could satisfy the underlying research, surveillance, longitudinal-comparability, and program-integrity objectives. All analytical work would be performed within the contractor’s environment.

Respondents are encouraged to identify assumptions, dependencies, limitations, data-rights considerations, transition requirements, and recommended changes that could improve feasibility, competition, performance, or value.

CONTEMPLATED TASK REQUIREMENTS: The Government is contemplating a requirement for a contractor to provide project management, research, data analysis, clinical review as needed, and written analytic products addressing HHS priorities. The contractor would be expected to provide written analyses describing findings, methods, and limitations.

The contemplated contract includes the following task areas:

1. Task 1 – Drug Safety, Patient Safety, and Program-Integrity Research. Conduct cross-payer research addressing drug safety, patient safety, program integrity, and fraud-related questions. Analyses may include utilization, exposure, and outcome patterns; geographic, payer, and care-setting variation; coding and coverage patterns; cross-payer billing anomalies; provider, facility, or prescriber outlier analyses; and assessment of suspected billing schemes. The contractor must be capable of supporting rapid-response research, recurring analyses as new claims become available, clinical review when necessary, and ongoing prioritization with HHS.

The contractor shall characterize how a category of clinical services, designated by HHS, is delivered across payers, including volume and trend, geography, payer type, care setting, and coding and coverage patterns.

The contractor shall also answer program-integrity questions analytically across payers: whether a billing or coding pattern deviates from cross-payer norms; whether a provider, facility, or prescriber is a statistical outlier after payer mix and case mix are accounted for; and whether a suspected pattern is present in the claims and at what dollar scale.

When HHS needs an answer on short notice, the contractor shall produce a rapid-response brief and then resume standing work. Anticipated products include study reports and supporting aggregate datasets, safety analyses, program-integrity and fraud findings memoranda, and confidential billing-integrity referral packages.

2. Task 2 – Retrospective Safety Evaluation, Surveillance Framework, and Targeted Prospective Study. On the ordinary schedule, a drug-safety review runs longer than six months. The Government wants to know whether a source has an accelerated schedule under which it can scale staffing, clinical review, and compute so that findings from a drug-safety review are, at the latest, delivered within six months of award with substantive progress reporting every two weeks.

a) Task 2a – Baseline Safety Profile. Establish the evidentiary base and cohort/outcome framework for subsequent analyses; replicate current evidence using contemporary national data; and produce an updated national, all-payer characterization of drug safety under current conditions of use. Anticipated outputs include an evidence summary; FDA-aligned cohort, episode, and outcome framework; replication analysis; comprehensive safety analysis; drug-interaction analysis; and contraindication-population exposure analysis.

b) Task 2b – Essential Extensions. Conduct priority analyses addressing central regulatory questions, including comparative safety profile; subgroup and risk-pattern report; impact of the change in conditions of use, including interrupted time series and difference-in-difference estimates, pre-specified assumption checks, sensitivity analyses, and an interpretive summary written for regulatory use; cumulative exposure and repeat-use report; comparison of safety by care channel, including telehealth versus in-person where that distinction exists, with inference-model documentation and cohort sensitivity analyses; and inferred-exposure signal report for use that is not visible in claims, including inference-model documentation, confidence-tier cohort characteristics, outcome distributions, and an interpretive summary of how that visibility changes the safety picture.

c) Task 2c – Targeted Analyses. Conduct focused analyses extending the baseline and essential-extension work to address mortality and extended follow-up, including all-cause and cause-specific mortality, comparator analyses, and sensitivity analyses; pediatric and adolescent safety; mental-health outcomes with explicit treatment of confounding and limitations; care-pathway mapping; practice variation analysis; and evidence gaps and research priorities. The contemplated work culminates in a synthesis intended to inform regulatory research planning.

d) Task 2d – Prospective Ongoing Surveillance and Study. Provide ongoing safety surveillance and rolling updates to support continuous regulatory visibility, assess delayed and long-horizon outcomes, and establish a bridge between retrospective analyses and prospective/interventional research. The contemplated outputs include ongoing safety-surveillance updates and development and maintenance of a long-horizon outcomes cohort.

INSTRUCTIONS: Please identify the question number for each response. Each responding entity should submit one consolidated response. Respondents are encouraged to answer all the questions. Answer each question for the capability you would use on the day of award, not for a capability you would assemble during performance. A response that does not hold the requisite capabilities or that meets capabilities only by subcontracting data or methods it does not now hold should clearly identify those dependencies so the Government can assess capability, transition requirements, and potential effects on competition.

This RFI is voluntary. Please do not submit classified information, personally identifiable information (PII), protected health information (PHI), or other sensitive information. Respondents should clearly mark any information they consider proprietary or confidential and should avoid providing proprietary data unless necessary to explain a capability.

QUESTIONS

A. Respondent Information and Minimum Capability

1. Provide the following respondent information:

a) Legal business name, address, website, and primary point of contact.

b) UEI, CAGE code, and current SAM.gov registration status.

c) Business size and applicable socioeconomic status.

d) If other than small, identify whether you anticipate subcontracting any portion of the requirement to a small business. Respond “Yes” or “No.” If “Yes,” identify the anticipated type of small business concern.

e) Is your SAM.gov registration active and UEI complete? Respond “Yes” or “No.” If “No,” briefly state what remains.

2. Can your organization perform as the prime contractor under a standalone firm-fixed-price award? Respond “Yes” or “No.”

3. Does your organization have any known or potential organizational conflict of interest that could affect performance of drug-safety, patient-safety, or program-integrity analyses under this requirement? Respond “Yes” or “No.” If “Yes,” briefly identify the conflict and proposed mitigation.

B. Data Asset and Data Rights

4. Does your organization currently own, license, or otherwise control a de-identified all-payer claims data environment that meets each of the following minimum characteristics? Respond “Yes” or “No” for each item. For any “No” response, briefly identify the limitation.

a) Integrated medical, facility, and pharmacy claims across commercial, Medicaid, Medicare fee-for-service, Medicare Advantage, VA, TRICARE, and other payers.

b) Does the existing data environment you would use for this requirement meet the contemplated scale of more than 300 million unique de-identified lives, approximately 5 billion transactions per year, and more than 700 billion records? If “No,” briefly provide the corresponding scale of the data environment you would use.

c) Nationwide coverage across all 50 states and longitudinal history from 2015 forward.

d) Regular refreshes supporting near-current analysis.

e) Does the claims data you would use for this requirement include closed/adjudicated claims? Respond “Yes” or “No.” If “Yes,” indicate whether the data environment consists of (1) predominantly closed/adjudicated claims or (2) a combination of closed/adjudicated and open claims. If a combination, briefly identify which payer populations or data components rely materially on open claims.

f) List the current refresh cadence and approximate lag for the newest usable claims.

5. Can you follow one de-identified patient across payers, states, and settings in that asset from 2015 through the latest refresh? Respond “Yes” or “No.” If “No,” briefly identify material limitations.

a) Are there material categories of care or utilization that are not captured in the data environment, such as cash-pay, 340B, dispensing outside the benefit, or telehealth? Respond “Yes” or “No.” If “Yes,” briefly identify the material gaps.

6. Does your organization currently have operational linkages within the existing data environment you would use for this requirement? For each, respond “Yes” or “No.”

a) Mortality data

b) Social determinants of health data

c) EHR-derived attributes

d) Other supplemental data sources (if “Yes,” briefly identify)

7. Is the data environment de-identified in accordance with applicable legal and contractual requirements for the contemplated work? Respond “Yes” or “No.” If “Yes,” identify the de-identification method (e.g., expert determination or safe harbor).

C. Personnel and Clinical Review

8. Does your organization currently have the personnel capabilities needed to perform the requirement at award? For each, respond “Yes” or “No.”

a) Clinical review

b) Epidemiology

c) Data engineering

d) Biostatistical/advanced analytical support

9. Can your organization provide clinical review appropriate to the drug-safety analyses in Task 2? Respond “Yes” or “No.” If “Yes,” list available clinical specialties.

10. Can your organization maintain the required clinical review, epidemiology, data engineering, and analytical capabilities throughout the period of performance? Respond “Yes” or “No.”

D. Minimum Analytical Capabilities

11. Can your organization use its existing data and analytical environment to define and characterize a clinical-service category, including utilization volume and trends, geography, payer type, care setting, and relevant coding and coverage patterns? Respond “Yes” or “No.”

12. Can your organization use claims data to identify patterns potentially indicative of the following? For each, respond “Yes” or “No.”

a) Upcoding

b) Unbundling

c) Duplicate billing

d) Billing for services potentially not rendered

e) Medically unnecessary utilization patterns

f) Provider, facility, or prescriber statistical outliers

13. Can your organization identify provider, facility, or prescriber statistical outliers using methods that account for payer mix, case mix, small denominators, and normal statistical variation? Respond “Yes” or “No.”

14. Does your organization currently maintain an established cohort, episode, and outcome framework capable of supporting the contemplated drug-safety analyses? Respond “Yes” or “No.” If “Yes,” briefly identify the types of cohorts, episodes, exposures, comparators, and outcomes supported.

15. Using data and analytical capabilities currently available to your organization, can your organization perform the following? For each, respond “Yes” or “No.”

a) Before-and-after analysis of a change in conditions of use

b) Interrupted time-series analysis, including appropriate assumption checks and sensitivity analyses

c) Difference-in-differences analysis, including appropriate assumption checks and sensitivity analyses

d) Comparative safety analysis

e) Subgroup and risk-pattern analysis

f) Cumulative-exposure and repeat-use analysis

g) Care-channel comparisons, including telehealth versus in-person where applicable

h) Inferred-exposure analysis for exposure not directly observable in claims

i) All-cause mortality analysis

j) Cause-specific mortality analysis

k) Pediatric and adolescent safety analysis

l) Mental-health outcomes analysis

m) Care-pathway analysis

n) Practice-variation analysis

o) Replication of prior evidence using contemporary national data

p) Drug-interaction safety analysis

q) Contraindication-population exposure analysis

r) Ongoing safety surveillance and rolling updates

s) Development and maintenance of a long-horizon outcomes cohort

16. Does your organization currently have an established analytical method for inferring exposure that is not directly observable in claims? Respond “Yes” or “No.” If “Yes,” briefly identify the type of methodology and whether it provides confidence tiers or another measure of uncertainty.

17. Does your organization have established quality-control and documentation processes that make analytical findings reproducible and auditable, including documentation of data inputs, cohort and outcome definitions, analytical methods, assumptions, limitations, and quality-control procedures? Respond “Yes” or “No.”

E. Schedule and Readiness

18. Can your organization begin substantive performance at award using existing data access, personnel, analytical infrastructure, and security arrangements? Respond “Yes” or “No.” If “No,” state the minimum startup period required.

a) Data access available at award. Respond “Yes” or “No.”

b) Required personnel available at award. Respond “Yes” or “No.”

c) Analytical and security environment ready for performance at award. Respond “Yes” or “No.”

d) Can your organization complete the Task 2a-2c analyses and associated deliverables within six months of award using capabilities available at award? Respond “Yes” or “No.” If “No,” state the shortest achievable schedule.

e) Can your organization provide substantive progress updates every two weeks during the six month period? Respond “Yes” or “No.”

F. Data and Deliverable Rights

19. Do your existing data licenses permit the contemplated analytic deliverables, including aggregate outputs and provider-level referral packages, to be delivered to HHS? Respond “Yes” or “No.” If “No,” briefly identify the restriction.

20. Can the Government receive unlimited rights in contract deliverables while the contractor retains rights in the underlying claims data? Respond “Yes” or “No.” If “No,” briefly identify the restriction.

G. Relevant Experience

21. Does your organization have prior experience performing work substantially similar to Task 1 and Task 2? Respond “Yes” or “No.” If “Yes,” list up to two representative examples, identifying the customer, period of performance, your role, and the task area(s) performed.

a) Customer and contract number, if federal.

b) Your role and period of performance.

c) Brief description of the work performed.

d) Was performance completed on an accelerated or compressed schedule? Respond “Yes” or “No.”

e) Identify whether the example is most relevant to Task 1, Task 2, or both.

H. Interest and Barriers

22. Would your organization be interested in responding to a solicitation for this requirement? Respond “Yes” or “No.” If “No,” identify the principal barrier(s) to participation.