Draft SOW.pdf

Draft Statement of work

Title: Utilization Patterns and Billing Integrity Analysis

C.1 PROGRAM DESCRIPTION AND BACKGROUND

The mission of the U.S. Department of Health and Human Services (HHS) is to enhance the health and well-being of all Americans, by providing for effective health and human services and by fostering sound, sustained advances in the sciences underlying medicine, public health, and social services.

HHS oversees federal health programs and the providers and facilities that bill them.

Administrative claims data can characterize how a category of care is delivered and can surface billing patterns that merit investigation.

The Contractor shall provide ongoing analytic support across two domains: (1) drug safety, patient safety, and program-integrity research and (2) a comprehensive retrospective safety evaluation with framework for ongoing surveillance and targeted prospective study. The Contractor will 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 action.

C.2 STATEMENT OF WORK

The Contractor shall furnish all necessary personnel, materials, services, and facilities (except as otherwise specified herein) and shall do all things necessary for or incident to the performance of the work as set forth below:

C.2.1 TASK REQUIREMENTS

Purpose: To provide ongoing project management, research, data analysis, clinical review (as needed), and written analytic products addressing HHS priorities as described below.

The Contractor shall deliver written analytic briefs that answer HHS research questions and describe findings, methods, and limitations. Briefs shall be delivered confidentially to HHS.

The Contractor shall perform the work using de-identified, all-payer claims database, which integrates medical, facility, and pharmacy claims from commercial, Medicaid, Medicare, Medicare Advantage, VA, Tricare, and other payers, covering all 50 states and longitudinal history from 2015 forward with more than 300 million unique de-identified lives, approximately 5 billion transactions per year, and more than 700 billion records. The database shall be refreshed on a regular cadence for near-current visibility. Use of linked supplemental sources will require a modification to the contract.

All work under this contract shall be performed using data owned or independently licensed by the Contractor and processed solely within the Contractor’s information systems and on

Contractor-owned or Contractor-provided equipment. The Contractor shall not require custody of HHS- or CMS-held data. No Government-furnished data, equipment, information technology, information systems, or facilities shall be provided or required for performance. No Government information system shall be accessed, operated, maintained, or developed by the Contractor on the Government’s behalf. All analytical processing shall occur within the Contractor’s security environment. The Contractor’s information systems and data environment are not Government information systems, Federal information systems, or information systems operated on behalf of the Government. Accordingly, requirements applicable solely by virtue of a contractor accessing, operating, maintaining, or developing a Government or Federal information system, including requirements to obtain or maintain an HHS Authority to Operate (ATO) for the Contractor’s systems, shall not apply to the Contractor’s internal information systems used to perform this requirement. The Government will not sponsor, authorize, or issue an ATO for the Contractor’s internal information systems or commercial data environment used solely to perform this requirement. The Government will receive only the analytic deliverables specified in this contract, produced using Contractor-owned or Contractor-licensed data and Contractor-owned or Contractor-provided equipment and information systems.

The Government receives unlimited rights to all deliverables produced under this contract (FAR 52.227-14). The Government receives no right, title, license, or interest in the underlying licensed claims data from which the deliverables are produced. The data is not a deliverable and is not subject to delivery, inspection, or transfer under this contract, and nothing in this contract obligates the Contractor to deliver record-level data or to grant access to its data environment.

Intermediate, working, and derived data created during performance are likewise not deliverables. To the extent any deliverable would incorporate material in which the Contractor asserts less than unlimited rights, that material will be identified and marked with limited rights notice before delivery.

TASK 1 – Drug Safety, Patient Safety, and Program-Integrity Research

During the base period, HHS will pose safety research questions and program-integrity and fraud research questions, and the Contractor will provide focused written briefs. The Contractor shall not exceed 3,360 cumulative labor hours of analytic work for all labor categories under CLIN 1001. If Option Period 1 is exercised, HHS may continue to pose Task 1 research questions under CLIN 2001 within the fixed price for that CLIN. The Contractor shall not exceed 1,334 cumulative labor hours of analytic work for all labor categories under CLIN 2001

The Contractor shall conduct drug safety and patient safety research across payer populations, drawing on its all-payer claims data to observe utilization, exposure, and outcome patterns that are not visible within any single payer’s database. The Contractor shall characterize how clinical services are delivered across payers, including utilization volumes and trends; distribution by geography, payer type, and care setting; and coding and coverage patterns.

The Contractor shall resolve questions related to program-integrity and fraud analytically across payers: whether a billing or coding pattern deviates from cross-payer norms; whether a provider, facility, or prescriber is a statistical outlier once payer mix and case mix are accounted for;

whether a suspected scheme is present in the claims record and at what dollar scale.

When HHS requires an answer on short notice, the Contractor shall reprioritize work to produce a rapid-response brief and then resume standing work. Recurring questions shall be re-run as new claims data become available, with visuals refreshed on request. Clinical review associated with a refresh may require additional effort and prioritization. The Contractor shall conduct weekly check-ins with HHS to set priorities, review work in progress, and confirm the next analytic cycle.

Deliverables:

• Study reports and the supporting aggregate datasets for research completed.

• Safety research analyses, including refreshes of measure sets developed.

• Program-integrity and fraud analytic findings memoranda.

• Confidential billing-integrity referral packages for patterns in aggregate measures warranting oversight review.

TASK 2 – Comprehensive Retrospective Safety Evaluation with Framework for Ongoing Surveillance and Targeted Prospective Study

Task 2a: Baseline Safety Profile

The Contractor shall establish the evidentiary base, build the cohort and outcome framework that will anchor downstream analysis, replicate current evidence study using contemporary national data, and produce an updated, national all-payer characterization of drug safety under modern conditions of use.

Deliverables:

• Evidence Summary

• FDA-aligned Cohort, Episode and Outcome Framework

• Replication Output

• Comprehensive Safety Summary covering complications, failures, and acute events

• Drug-Interaction Safety Report

• Contraindication-Population Exposure Report

Task 2b: Essential Extensions

The Contractor shall provide priority analyses FDA has flagged as central regulatory questions.

Deliverables:

• Comparative Safety Profile

• Subgroup and Risk-Pattern Report

• REMS Impact and Longitudinal Trend Report, including ITS and DiD estimates, pre-specified assumption checks, sensitivity analyses, and an interpretive summary written for regulatory use

• Cumulative Exposure and Repeat Use Report

• Telehealth versus In-Person Comparative Safety Report, including the inference model documentation and cohort sensitivity analyses

• Inferred Exposure Signal Report, including the inference model documentation, confidence-tier cohort characteristics, outcome distributions, and an interpretive summary of how visibility into the non-claims-visible exposure population changes the overall safety picture

Task 2c: Targeted Analyses

The Contractor shall provide focused analyses that address specific safety questions extending beyond Tasks 2a and 2b with a closing synthesis.

Deliverables:

• Mortality and Extended Follow-Up Report, including all-cause and cause -specific mortality estimates, comparator analyses, and sensitivity-analysis findings

• Pediatric and Adolescent Safety Report

• Mental Health Outcomes Report, with explicit treatment of confounding and limitations

• Care Pathway Mapping Report

• Practice Variation Analysis Report

• Evidence Gaps and Research Priorities Synthesis, structured for direct use in FDA regulatory planning

Task 2d: Prospective Ongoing Surveillance and Study

During the base period and Option Period 1, the Contractor shall provide continuous regulatory visibility, delayed and long-horizon outcomes, and a bridge between retrospective and interventional work.

Deliverables:

• Ongoing Safety Surveillance and Rolling Updates

• Long-Horizon Outcomes Cohort