IQVIA_Synopsis_2024.docx

Description This is a Notice of Proposed Contract Action Synopsis: The Centers for Medicare & Medicaid Services (CMS) intends to issue a new sole-source contract to the IQVIA pursuant to the authority of FAR 8-405-6(a)(1)(i)(B). Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized.

CMS intends to obtain the services unique to IQVIA which is to provide data to the Medicare Drug Rebate and Negotiations Group (MDRNG) within the Center for Medicare (CM) at CMS. CMS requires this data in order to implement, monitor and operationalize certain provisions of the Inflation Reduction Act (IRA) of 2022 (P.L. 117-169). CMS created the Medicare Drug Rebate and Negotiations Group (MDRNG) to implement the IRA Medicare Drug Inflation Rebate and Medicare Drug Price Negotiation Programs.[footnoteRef:1] Under this procurement initiative, MDRNG will specifically support IRA implementation and monitoring by accessing data and information in order to: Monitor drug prescribing behavior, drug distribution, manufacturer behavior, prescribing dynamics, identifying therapeutic alternatives, generic/biosimilar entries, etc. details and use cases. [1:

Department of Health and Human Services. "Establishment of the Medicare Drug Rebate and Negotiations Group Within the Center for Medicare (CM)." Federal Register Vol. 87, no. 198. (October 14, 2022): Page 62433, https://www.federalregister.gov/d/2022-22296. ]

Collection and Management of IQVIA Databases

The primary purpose of this task order is to provide data to the Medicare Drug Rebate and Negotiations Group (MDRNG) within the Center for Medicare (CM) at CMS. This task order will provide MDRNG prescription drug data from IQVIA (“The Contractor”). The Contractor shall be able to provide prescription drug price and utilization data that can be used by MDRNG to provide estimates of prescription drug activity, which are critical to inform many high priority activities within the Department, implement the IRA, and monitor total brand spending, dispensed prescriptions, pharmaceutical sales force, biotechnology products, longitudinal prescription data, pre-adjudicated claims data for outpatient and inpatient claims, and primary care electronic medical records.

CMS has a need for access to domestic drug spending and utilization data to support the Inflation Reduction Act implementation and monitoring. Through IQVIA, MDRNG will have access to data and information to support these actions and will share specific data products and analytic tools with CMS. MDRNG will work with the Office of Acquisition and Grants Management (OAGM) to award a task order to IQVIA that provides subscription access to domestic drug spending and utilization databases. This includes but is not limited to: National Sales Perspectives (NSP), National Prescription Audit (NPA), Total Patient Tracker (TPT), and PayerTrak.

MDRNG plans to award a new sole source task order with IQVIA for data and analytic tools and to cover associated fees so that MDRNG can conduct analyses needed for implementation, monitoring, and of the Inflation Reduction Act drug pricing provisions, in coordination with CMS; and share findings and products with CMS for internal use or review before external release. The reason that IQVIA has been the sole source to support the above described requirements is that they own, support, and maintain prescription drug and related data. CMS has a need for IQVIA to support the IRA to provide services for analysis of Medicare, Medicaid, and Marketplace data on prescription drug spending and utilization that can be used to produce estimates of prescription drug activity, which will inform high-priority activities. Access to specific databases, that only IQVIA obtains, will allow CMS to support the IRA. IQVIA owned databases of high importance to CMS include but are not limited to NSP, ChannelDynamics, Pipeline Intelligence, Xponent PlanTrak, OneKey, Remittance Data, and Formulary Impact Analyzer.

IQVIA owns the proprietary rights to the system of various databases that provide details and use cases on total brand spending, dispensed prescriptions, pharmaceutical sales force, biotechnology products, longitudinal prescription data, pre-adjudicated claims data for outpatient and inpatient claims, and primary care electronic medical records. As some of these data sets are not currently available to MDRNG, IQVIA is uniquely qualified to provide the described resources and requirements. As the organization that maintains and evolves various health outcome data, IQVIA is the only responsible source for this activity.

The contract's period of performance will be a base year plus four option years. This notice is a notice of intent to negotiate and award a contract to IQVIA and should not be considered a request for proposals. This synopsis should not be construed as commitment by the Government for any purpose other than market research. All responsible sources may submit a capability statement that will be considered by the agency. The statement must demonstrate that the firm(s) has the capability to perform the required work. All capability statements must be submitted via email to Amberly Kovalick at: Amberly.Kovalick@cms.hhs.gov on or before close of business Wednesday, August 14, 2024. Voice communications will not be entertained. A determination by the Government not to compete this proposed action based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. CMS will not reimburse costs for submission of capability information. All documentation shall become the property of the Government.

Please note that any firm interested in this synopsis must be able to successfully provide data equivalent to what is described above.