By Maureen Testoni
Feb. 17, 2022– In many ways, last month’s 340B Coalition Winter Conference in San Diego was a cause for celebration. We celebrated the first chance we had to come together in person as a community in two years. And we celebrated the start of a historic year for the 340B drug pricing program, which will turn 30 years old this November.
When 340B hospitals, health centers, health clinics, service providers, and other stakeholders convened online last summer, I expressed my fervent hope that it would be the last time we gathered virtually due to the COVID-19 pandemic. Thanks in no small part to the dedicated work of these institutions on the front lines of the health emergency, that hope became a reality. The winter conference enabled us to reconnect with our friends in the community, get back to sharing best practices for using 340B resources to care for patients in need, and recommit to tackling the challenges facing those dedicated to the program’s future.
30 Years of Access to Patient Care
As I looked out across a sea of more than 1,400 masked faces during my opening remarks for the conference (and with hundreds more watching online), I was filled with gratitude that we could be together again in service to the 340B program and the patients who rely on it. Much of my address focused on those patients and how 340B providers have been there for them over the course of three decades.
The success stories of those patients are now legion. In the nearly 30 years since President George H.W. Bush signed Section 340B of the Public Health Service Act into law on Nov. 4, 1992, millions of patients have benefited from the program. And millions more will benefit in the years and decades ahead.
I noted that these success stories include trauma patients receiving lifesaving emergency care from rural hospitals, patients with diabetes obtaining insulin and care support from community health centers, patients with bleeding disorders receiving specialized services from hemophilia treatment centers, and patients with HIV/AIDS and hepatitis whose access to clinics have put cures within reach. Most of them might never have heard of the 340B program, but their lives and health are better because of it.
This success is something to reflect on with pride as we look at the myriad ways the 340B program has grown in the past 30 years to meet the needs of patients and communities throughout the U.S. All this year, 340B Health and other members of the 340B Coalition will be engaging in a celebration leading up to the 30th anniversary in November. We see it as a time of reflection but also the start of a bright future for the patient missions of 340B providers.
A Mission Challenged
Those 340B patient missions have faced one of the most challenging years to date. Much of my address at the conference focused on the threats to the program posed by a relatively small group of pharmaceutical drug companies and their allies who are intent on stifling and reversing the same growth in the program that has been a key element of 340B’s success.
Fourteen companies to date have imposed unilateral restrictions on 340B, targeting providers that partner with local community pharmacies to provide drugs to their patients and to extend care to more patients in need. We have seen very concerning data from hospitals that are losing significant portions of their 340B savings through these unlawful actions. And I fear that this is only the tip of a very dangerous iceberg, as not all the drug company policies had taken full effect when hospitals reported those figures at the end of 2021.
Thankfully, the 340B community is united and strong against these attacks on the program, and so is the federal government. Conference attendees heard from Rear Admiral Krista Pedley and Michelle Herzog, two senior officials in the government agency that oversees the 340B program. They renewed their support for the program in some of the strongest terms yet, and they detailed the agency’s latest efforts to enforce the 340B law and restore the discounts that companies are refusing to offer. The government so far has sent letters to seven drugmakers informing them they are violating the law and has referred six of them for consideration of potential penalties for intentionally overcharging safety-net providers.
In my address, I applauded the government for not backing down in this fight, and I made it clear the 340B community is not backing down either. The issue is pending before several federal appeals courts, and there are other avenues toward a solution to this problem. And if one of those pathways leads to Capitol Hill, we are prepared to go in that direction.
A Familiar Feeling
Amid the challenges that our health care safety net faces from the pandemic and drug company attacks on 340B, I am heartened by the continued commitment of providers to making 340B work for the benefit of their patients. More than 100 speakers at the conference offered best practices on how covered entities can run efficient, effective, and compliant 340B programs at their institutions.
Were it not for the masks, vaccination record checks, and other health precautions, this would have felt to me like any one of the dozens of in-person conferences the 340B Coalition has held over the better part of three decades. In many ways, the 340B community has not skipped a beat over the past two years and has been dauntless in its mission to patients in need.
This is just the latest chapter in a long and storied history for the 340B program. Here’s to the past 30 years, the next 30 years, and beyond!
Maureen Testoni is the President and CEO of 340B Health