Use Research to Fight 340B Program Threats

Pharmacists can help counter the ever-increasing threats to the 340B Drug Pricing Program by publishing data demonstrating how revenue from the program improves the lives of vulnerable patients, says Caroline R. Steinberg, vice president of research and policy analytics for 340B Health in Washington, D.C.

“We are really encouraging hospitals ... to do their own research on 340B programs, because having published research that we can point to adds a lot of credibility to our advocacy efforts,” said Steinberg, the lead speaker for the on-demand Midyear session 340B Research: Telling the Story, Protecting the Program.

“340B research is critical to dispel myths about the program that are put out by program opponents,” she explained.

Steinberg said common myths about the 340B program are that it drives increases in the cost of individual drugs and creates incentives that increase overall drug spending. But she said a growing body of research contradicts these claims.

For example, she said, the Medicare Payment Advisory Commission’s 2020 report to Congress found “no evidence at all that spending increased when a hospital entered the 340B program.” And research published this year in JAMA indicates that prices for 340B-covered drugs in the Medicare Part D program rose at a slower rate than for other drugs, accounting for about $7 billion in projected savings for Medicare Part D from 2013 to 2017.

Questions have also been raised about whether the underserved populations that are targets of the 340B program truly benefit from it.

An analysis released this year by 340B Health found that, compared with non-340B hospitals and physician offices, disproportionate share hospitals that participate in the 340B program treat larger percentages of cancer patients who are low-income, disabled, or members of racial or ethnic minority populations.

“This means that the program is appropriately targeted towards hospitals that serve more vulnerable, underserved populations,” Steinberg said.

But she said these findings aren’t enough to protect the 340B program from recently enacted drug manufacturer policies that prevent hospitals’ contract pharmacies from obtaining federally mandated discounts on 340B-covered drugs.

Steinberg said about 75% of 340B Health’s member hospitals use a contract pharmacy to fill 340B-covered prescriptions.

Also of concern to hospitals is a proposed Medicare Part B policy that will further decrease already low reimbursement for 340B-covered drugs by 6.2 percentage points. Steinberg said it’s important for hospitals to share with policymakers any data that demonstrate how the proposed cut will adversely affect communities.

Steinberg said that if hospitals don’t have research data, vignettes and personal stories can also appeal to policymakers.

She said conversations with policymakers should always include at least one example of how 340B-funded services have changed a specific patient’s life.

340B Health this year began offering modest grants to help hospitals develop research programs whose results can be published in the scientific literature.

Steinberg said a small grant to fund data processing by the applicant’s analytics team may be all that’s needed to get a 340B study off the ground.

David Twitchell, vice president of Boston Medical Center Health System, said quality improvement (QI) projects, which lack the blinding and structure of classic research, are a good place to get started with research.

“Use a quality improvement framework to structure your work, and just start simple. This gets you early wins, and it allows you to tell a story,” he said. “I don’t think there’s anything better than a great patient story.”

He said QI initiatives at his public hospital were a steppingstone to published reports, funded with 340B program revenues, that demonstrated improvements in hepatitis C virus screening, linkage to care, and treatment.

Twitchell said when a project could not have existed without 340B funding, it’s critical to note that in published reports about the project.

“Our physician partners have been more than happy to do that for us,” he said.

This news story was published in the Dec. 10 issue of ASHP’s Midyear 2020 News & Views. The session is available for on-demand viewing until March 10.