An autoimmune disease diagnosis can mark the start of a difficult medical battle. But for too many patients, it also marks the beginning of a financial one.
Many of the 50 million Americans living with lupus, rheumatoid arthritis, Crohn’s disease, multiple sclerosis, psoriasis, or other autoimmune diseases rely on expensive therapies and specialty care to manage their conditions and prevent flare-ups. Yet even with insurance, they often struggle to afford the care they need.
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More than three decades ago, Congress created the 340B Drug Discount Program to help exactly these kinds of vulnerable patients. But today, the program has veered far off course. It’s past time for lawmakers to reform 340B and ensure it actually works for the patients it was meant to serve.
When Congress established the 340B program in 1992, the goal was simple: help safety-net providers stretch scarce resources and expand care for low-income and uninsured patients. While that mission remains just as important today as it was then, the program itself has changed dramatically over time.
What began as a safety-net initiative expected to enroll about 90 hospitals has grown into the second-largest federal drug program in the country, with nearly 3,000 participating hospitals. Collectively, 340B entities purchase more than $80 billion in discounted drugs annually.
Those numbers represent an extraordinary amount of growth. What’s missing are the transparency and oversight measures necessary to ensure that patients are consistently benefiting from it.
The 340B program gives safety-net providers access to steep discounts on outpatient drugs. In theory, they’re supposed to invest those savings into care for low-income and uninsured patients. But in practice, many hospitals buy medicines at a discount, receive reimbursement from insurers at a higher, non-discounted rate, and retain the difference.
The problem persists largely because 340B operates with too little accountability. Participating hospitals are not required to show whether the savings they generate lower patients’ costs or expand access to care. Public reporting remains limited, and federal oversight has failed to keep pace with the program’s size and complexity.
The results are troubling. One recent claims analysis found that participating 340B hospitals and clinics passed only 1.4% of eligible prescription discounts directly to patients, even as they generated an estimated $66 billion in profit from those same discounted purchases in 2024.
Worse, the program may actually be contributing to higher healthcare costs across the system.
Because hospitals can acquire drugs at a discount while billing insurers at the full price, the program incentivizes hospitals to steer patients toward more expensive drugs. In 2023, drug spending for commercially insured patients was roughly three times higher at 340B hospitals than at hospitals that don’t participate in the program.
Those spending patterns have consequences beyond individual hospitals. One analysis estimated that 340B’s growth added roughly $23 billion to employer healthcare costs in a single year. That leads to higher insurance premiums and out-of-pocket burdens for patients and their families.
For people living with autoimmune diseases, these added costs can be devastating. They can mean a delayed infusion, a prescription left unfilled, or another month of choosing between treatment and rent, groceries, or gas. A program created to expand access to care should not be making those choices harder.
Lawmakers now have an opportunity to restore 340B to its original purpose. They can start by passing reforms consistent with the 340B ACCESS Act, which would increase transparency, strengthen oversight, clarify patient eligibility standards, and help ensure that more of the program’s benefits reach low-income and uninsured patients.
At the same time, reform should not come at the expense of the providers that genuinely serve vulnerable communities. Congress should preserve access to 340B for community clinics and true safety-net providers that rely on the program to care for patients in need.
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Ultimately, policymakers should judge the success of 340B not by how much money flows through the program, but by whether patients can access and afford the care they need.
More than three decades after Congress created 340B, patients with autoimmune diseases — and all vulnerable patients — deserve a program that delivers on its original promise.
Amanda Krzepicki is the policy director at the Autoimmune Association.
