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 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.

Fourth Amendment Protections of Prescription Drug Monitoring Programs: Patient Privacy in the Opioid Crisis.

The opioid crisis is one of the largest public health problems in the history of the United States. Prescription drug monitoring programs ("PDMPs")-state databases containing the records of all prescriptions for controlled substances written in the state-have emerged as a means to track opioid prescribing and use. While PDMPs are typically used as a tool for physicians to inform their prescribing practices, many states also permit law enforcement to access PDMPs when investigating controlled substance distribution, often without prior judicial approval. Such law enforcement use of PDMPs raises serious questions of patient privacy. The Fourth Amendment protects individuals from unreasonable searches and seizures where they have a reasonable expectation of privacy and has been interpreted to require law enforcement have probable cause and a search warrant before infringing upon an individual's reasonable expectation of privacy. Several courts have held that patients have no reasonable expectation of privacy, or a severely diminished expectation of privacy, in their prescription drug records held in PDMPs. As support, courts rely on the third-party doctrine because the information is disclosed to physicians and then held by the state; the highly regulated nature of the prescription drug industry; and the statutory framework of the Controlled Substances Act. Such analysis disregards patients' expectation of privacy in their personal health information, the confidentiality in the physician-patient relationship, and the resulting patient incentives not to seek care. Therefore, this Article argues that law enforcement must have probable cause and a search warrant to access PDMPs because the exceptions to the Fourth Amendment's probable cause and warrant requirements do not apply.