Thursday, May 29, 2025
5/29/2025
Impact of the 340B Drug Pricing Program on Medication Utilization, Health Outcomes, and Disparities in Medicare - PROJECT SUMMARY Inadequate medication access and adherence causes poor health in the aging Medicare population—issues which are particularly salient among disadvantaged populations. The 340B Drug Pricing Program is an expansive, federal safety net program that intends to improve medication access and health outcomes for disadvantaged patients. It entitles qualifying hospitals or clinics to large manufacturer discounts when they purchase and dispense infused, injected, or oral outpatient drugs. The intent is for 340B hospitals to use savings to increase drug access and invest in services to improve outcomes for disadvantaged patients; however, there are no direct incentives nor oversight criteria to ensure this occurs, and facilities are permitted to dispense 340B drugs to patients regardless of individual social or financial need. Moreover, the 340B Program’s financial structure incentivizes prescription of higher volumes and more expensive drugs. While this could result in improved guideline-concordant medication utilization and health outcomes, it could also lead to dispensing potentially inappropriate medications or higher priced drugs. Although most 340B hospitals report using Program savings for the intended purposes, there is limited objective evidence to substantiate these claims. Whereas prior 340B research focused on Part B (physician administered) drugs, recent changes make it critical to understand its impact on Part D (pharmacy dispensed) drugs. Recent FDA approvals of expensive Part D specialty drugs has resulted in Part D drugs becoming lucrative for 340B hospitals. 340B channels for dispensing Part D drugs have also multiplied. Hospitals could originally dispense 340B drugs through (and share savings with) one contracted pharmacy. This restriction was removed after 2010. Now, 340B hospitals may contract with an unlimited number of community pharmacies. This study will link multiple datasets with a 100% sample of Medicare Part D enrollees, and use quasi- experimental analytical methods to evaluate the: 1) impacts of 340B Program growth on volumes and characteristics of Medicare Part D medications overall and among disadvantaged subgroups; 2) impacts of 340B Program eligibility on guideline-concordant Medicare Part D medication initiation, adherence, and health outcomes for 8 diseases, overall and by disadvantaged subpopulation; and 3) whether specific hospital-level characteristics are associated with positive impacts of 340B Program eligibility on guideline-directed medication use, adherence, and clinical outcomes in Medicare. This project aligns with NIA’s emphasis on health care disparities and patient adherence to treatment to promote health. Amidst competing legislative proposals to either reform the 340B Program or protect the status quo, this study will provide large-scale objective evidence on both intended and unintended consequences for Part D medication use and health outcomes to inform and guide 340B Program policy reform decisions and advance health equity.
HHS’ Tracking Accountability in Government Grants System (TAGGS) website provides access to detailed descriptions of grants, loans, aggregated direct payments and other types of financial assistance awarded by the HHS Operating Divisions (OPDIVs) and the Office of the Secretary Staff Divisions (STAFFDIVs).