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Outcomes of the 340B Drug Pricing Program: A Scoping Review

IMPORTANCE: The 340B Drug Pricing Program requires manufacturers to offer discounted drug prices to support safety net hospitals and clinics (covered entities) providing care to low-income populations. Amid expansion, the program has received criticism and calls for reform. OBJECTIVE: To assess the...

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Autores principales: Knox, Ryan P., Wang, Junyi, Feldman, William B., Kesselheim, Aaron S., Sarpatwari, Ameet
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Medical Association 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10665972/
https://www.ncbi.nlm.nih.gov/pubmed/37991784
http://dx.doi.org/10.1001/jamahealthforum.2023.3716
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author Knox, Ryan P.
Wang, Junyi
Feldman, William B.
Kesselheim, Aaron S.
Sarpatwari, Ameet
author_facet Knox, Ryan P.
Wang, Junyi
Feldman, William B.
Kesselheim, Aaron S.
Sarpatwari, Ameet
author_sort Knox, Ryan P.
collection PubMed
description IMPORTANCE: The 340B Drug Pricing Program requires manufacturers to offer discounted drug prices to support safety net hospitals and clinics (covered entities) providing care to low-income populations. Amid expansion, the program has received criticism and calls for reform. OBJECTIVE: To assess the literature on the foundations of and outcomes associated with the 340B program. EVIDENCE REVIEW: The databases searched in this scoping review included PubMed, Embase, EconLit, National Bureau of Economic Research (NBER), Westlaw, the Department of Health and Human Services Office of the Inspector General (HHS-OIG) website, the Government Accountability Office (GAO) website, and Google in February 2023 for peer-reviewed literature, legal publications, opinion pieces, and government agency and committee reports related to the 340B program. FINDINGS: Among a collected 900 documents, 289 met inclusion criteria: 83 articles from PubMed, 12 articles from Embase, 2 articles from EconLit, 1 article from NBER, 28 articles from Westlaw, 23 legislative history documents, 103 documents from Google, 11 GAO reports, and 26 HHS-OIG reports. Included literature pertained to 4 stakeholders in the 340B program: covered entities, pharmacies, pharmaceutical manufacturers, and patients. This literature showed that hospitals, clinics, and pharmacies generated revenue and manufacturers have forgone revenue from 340B discounted drugs. Audits of covered entities found low rates of compliance with 340B program requirements, whereas mixed evidence was uncovered on how covered entities used their 340B revenue, with some studies suggesting use to expand health care services for low-income populations and others to acquire physician practices and open sites in higher-income neighborhoods. These studies were hampered by a lack of transparency and reporting on the use of 340B revenue. Studies revealed patient benefits from access to expanded health care services, but there was mixed evidence on patient cost savings. Although the review identified considerable research on 340B hospitals, pharmacies, and patients, less research was found evaluating the 340B program’s effect on nonhospital covered entities, drug pricing, and racial and ethnic minority groups. CONCLUSIONS AND RELEVANCE: In this scoping review of the 340B program, we found that the 340B program was associated with financial benefits for hospitals, clinics, and pharmacies; improved access to health care services for patients; and substantial costs to manufacturers. Increased transparency regarding the use of 340B program revenue and strengthened rulemaking and enforcement authority for the Health Resources and Services Administration would support compliance and help ensure the 340B program achieves its intended purposes.
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spelling pubmed-106659722023-11-22 Outcomes of the 340B Drug Pricing Program: A Scoping Review Knox, Ryan P. Wang, Junyi Feldman, William B. Kesselheim, Aaron S. Sarpatwari, Ameet JAMA Health Forum Original Investigation IMPORTANCE: The 340B Drug Pricing Program requires manufacturers to offer discounted drug prices to support safety net hospitals and clinics (covered entities) providing care to low-income populations. Amid expansion, the program has received criticism and calls for reform. OBJECTIVE: To assess the literature on the foundations of and outcomes associated with the 340B program. EVIDENCE REVIEW: The databases searched in this scoping review included PubMed, Embase, EconLit, National Bureau of Economic Research (NBER), Westlaw, the Department of Health and Human Services Office of the Inspector General (HHS-OIG) website, the Government Accountability Office (GAO) website, and Google in February 2023 for peer-reviewed literature, legal publications, opinion pieces, and government agency and committee reports related to the 340B program. FINDINGS: Among a collected 900 documents, 289 met inclusion criteria: 83 articles from PubMed, 12 articles from Embase, 2 articles from EconLit, 1 article from NBER, 28 articles from Westlaw, 23 legislative history documents, 103 documents from Google, 11 GAO reports, and 26 HHS-OIG reports. Included literature pertained to 4 stakeholders in the 340B program: covered entities, pharmacies, pharmaceutical manufacturers, and patients. This literature showed that hospitals, clinics, and pharmacies generated revenue and manufacturers have forgone revenue from 340B discounted drugs. Audits of covered entities found low rates of compliance with 340B program requirements, whereas mixed evidence was uncovered on how covered entities used their 340B revenue, with some studies suggesting use to expand health care services for low-income populations and others to acquire physician practices and open sites in higher-income neighborhoods. These studies were hampered by a lack of transparency and reporting on the use of 340B revenue. Studies revealed patient benefits from access to expanded health care services, but there was mixed evidence on patient cost savings. Although the review identified considerable research on 340B hospitals, pharmacies, and patients, less research was found evaluating the 340B program’s effect on nonhospital covered entities, drug pricing, and racial and ethnic minority groups. CONCLUSIONS AND RELEVANCE: In this scoping review of the 340B program, we found that the 340B program was associated with financial benefits for hospitals, clinics, and pharmacies; improved access to health care services for patients; and substantial costs to manufacturers. Increased transparency regarding the use of 340B program revenue and strengthened rulemaking and enforcement authority for the Health Resources and Services Administration would support compliance and help ensure the 340B program achieves its intended purposes. American Medical Association 2023-11-22 /pmc/articles/PMC10665972/ /pubmed/37991784 http://dx.doi.org/10.1001/jamahealthforum.2023.3716 Text en Copyright 2023 Knox RP et al. JAMA Health Forum. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the CC-BY License.
spellingShingle Original Investigation
Knox, Ryan P.
Wang, Junyi
Feldman, William B.
Kesselheim, Aaron S.
Sarpatwari, Ameet
Outcomes of the 340B Drug Pricing Program: A Scoping Review
title Outcomes of the 340B Drug Pricing Program: A Scoping Review
title_full Outcomes of the 340B Drug Pricing Program: A Scoping Review
title_fullStr Outcomes of the 340B Drug Pricing Program: A Scoping Review
title_full_unstemmed Outcomes of the 340B Drug Pricing Program: A Scoping Review
title_short Outcomes of the 340B Drug Pricing Program: A Scoping Review
title_sort outcomes of the 340b drug pricing program: a scoping review
topic Original Investigation
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10665972/
https://www.ncbi.nlm.nih.gov/pubmed/37991784
http://dx.doi.org/10.1001/jamahealthforum.2023.3716
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