BEST Initative - Data Sources For Surveillance of Biologics

The Food and Drug Administration awarded this multiple-award IDIQ on September 30, 2020 to procure distributed-access healthcare data sources for FDA biologics surveillance, with ordering closed as of September 29, 2025. The vehicle is no longer active—the five-year ordering period ended nine months ago, and no new task orders will be placed.

The scope focuses on obtaining adjudicated administrative claims data and electronic health record data directly from primary sources (health insurers, payers, or providers) covering tens of millions of U.S. patients. Contractors must supply longitudinal healthcare data through distributed data networks, potentially using the OMOP common data model, and enable full medical chart access for patient review, abstraction, and adjudication in biologic product surveillance contexts. All seven awarded task orders use Time and Materials pricing.

Three primes hold the entire portfolio: The Lewin Group, Inc. ($44.4 million combined potential value across three orders) dominates with roughly 54% of contracted value, followed by Iqvia Government Solutions Inc. ($20.2 million, two orders) and CVS Healthspire Payor & Life Sciences LLC ($17.5 million, two orders). All task orders fund FDA programs exclusively—the vehicle serves a single customer agency.

Ordering activity peaked in 2020 and 2021 (three orders per year) and declined sharply to one order in 2023, the most recent award. The vehicle's combined potential value is $82 million, of which $77.9 million (95%) has been obligated. All seven awards are unrestricted, full and open competition with no set-aside designations. Task-order values range from approximately $1.7 million to $24.6 million, with typical durations of one to four years. The shared ceiling for the vehicle is $50 million. Contractors must be certified health data providers with direct access to large-scale patient datasets and the technical capability to support distributed data network models; commodity data intermediaries and non-primary-source vendors are ineligible.

The primary goal of this IDIQ is to obtain new data sources including administrative claims data or claims and EHR data with access to complete medical chart information, provided directly from primary sources such as an insurer, payer or provider. Contractors must provide FDA with: distributed-type access to large-scale, United States (US) health care data covering tens of millions of patients; adjudicated administrative claims data but data sources may also include EHR using a distributed data network which may use a common data model (CDM) (potentially OMOP CDM) (data sources shall provide longitudinal health care data for participating patients); access to full medical charts of patients whose health care data are available for review, abstraction, and adjudication in the context of biologic products surveillance activities; contractor must be a provider and primary source of the data such as health insurer, payer or provider.