Implications of the US 340B Drug Pricing Program for the Availability, Quality of Care, and Equitability of Syndemic (HIV/SUD/MH) health Services (340B AQCESS)

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PROJECT SUMMARY There is heated debate between drug manufacturers and hospitals about whether the 340B program lives up to Congress’ stated intent for the policy: “to stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.” The program allows certain “safety-net” medical providers, such as disproportionate share (DSH) hospitals, to purchase drugs from manufacturers at substantial discounts. In turn, these providers may offer the drugs to uninsured or underinsured outpatients at a reduced cost, thereby increasing the accessibility and affordability of health care. Providers may also sell these discount-purchased drugs at regular price to patients and their insurers, generating revenue, with few reporting requirements for how this money is spent. This has led to calls for reform. At the same time, existing evidence suggests the 340B Program likely plays an important role in the delivery of HIV, substance use disorder (SUD), and mental illness (MI) (“syndemic”) care in the United States. However, many questions remain. Previous studies of 340B have been unable to overcome selection bias; namely, 340B entities are inherently different than non-340B entities by virtue of being safety-net providers. Further, these studies only examined spending at 340B hospitals, not provision of relevant low-profit services. No studies have examined utilization or quality of care outcomes at 340B-enrolled providers. The immediate objective of this proposal is to test the hypothesis that revenue gained from enrollment in the program is reinvested by hospitals into crucial (but low profit) services such as HIV, SUD, and MI care. Further, this study will examine how the 340B program might affect the utilization and quality of behavioral health and HIV services for marginalized patient populations—in particular, the lesbian, gay, bisexual, transgender, and queer/questioning (LGBTQ) population. The LGBTQ population bears disproportionate burden of syndemic HIV, SUD, and MI. Indeed, the long-term goal of this research is to identity potential policy levers to improve access to care for all and to eliminate health disparities. The specific aims of this proposal are to: (1) evaluate the impact of the 340B program participation on hospital spending for safety-net and low-profit service lines; (2) quantify the provision of HIV, SUD, and MI health services in hospitals following 340B enrollment; and (3) assess the utilization and quality of syndemic care following 340B enrollment for DSH hospitals in Massachusetts. Because DSH hospital eligibility for 340B is determined in part by Medicaid patient volume, Medicaid expansion sets up a novel natural experiment for examining the downstream implications of 340B. The proposed research is innovative by utilizing Medicaid expansion as a natural experiment to assess quasi-random 340B enrollment and by focusing on the implications of the policy for the LGBTQ population. It is significant as our findings will have implications for how billions of dollars of health services are funded for U.S. safety- net providers, while identifying a potential opportunity to leverage these dollars to reduce syndemic health disparities. Support for this project would lay the groundwork for future studies in my career as a scientist researching actionable policy solutions to the syndemic of HIV, SUD, and MI in LGBTQ individuals and other marginalized populations.