Top federal 340B program officials and the head of a 340B hospital group yesterday urged covered entity representatives attending a meeting near Washington, D.C., to focus on documenting and telling their 340B success stories.
The need to show that 340B drug discounts help patients was a thread that ran through the three main speeches on Day One of the 340B Coalition annual summer conference. Attendees heard from U.S. Health Resources and Services Administration (HRSA) Administrator Carole Johnson, HRSA Office of Pharmacy Affairs (OPA) Director Lt. Cmdr. Emeka Egwim, and 340B Health President and CEO Maureen Testoni.
Johnson and Egwim were making their first appearances at a 340B Coalition event. It also was the first time in 12 years that U.S. Public Health Service Rear Adm. Krista Pedley did not speak on opening day at a coalition conference. Pedley, the ex-OPA director, was promoted in January 2021 to run a new office within HRSA that oversees 340B. Egwim was named her successor at OPA in February. Johnson became HRSA administrator in January, one year into the Biden administration.
This is the coalition’s first in-person meeting in the Washington, D.C., area since the COVID-19 outbreak. Testoni said more than 1,800 persons registered to attend.
Testoni said in her opening remarks that the 340B program has been getting more attention than ever in recent months, to the point that “on TikTok, there’s a whole bunch of videos about 340B from patients, talking about 340B.”
Testoni noted that her group and five others recently launched an “major advertising campaign to educate policymakers” about drug manufacturers’ restrictions on 340B pricing involving contract pharmacy “and why they must stop.” (Pharmaceutical Research and Manufacturers of America and AIDS Healthcare Foundation also have launched (PhRMA) or refreshed (AHF) their own 340B public awareness campaigns.)
“The message is simple: To protect patients, we must protect 340B,” Testoni said. Heightened national media interest in the drug pricing program creates opportunities “to make sure our messaging is coming through loud and clear,” she said. “There is an important role all of you can play in making sure this messaging is known. I’m urging you to keep documenting and publicizing how you use 340B to meet patients’ needs and what happens to that patient care when there are barriers to those savings. Every time you file an overcharge report with HRSA … I urge you to tell a story about a patient losing access to critical care. Or bring your concerns to elected officials.”
“All of those things are aiding our joint cause immensely,” she continued. “Lawmakers, judges, government officials, reporters, and health policy experts hear you when you speak up and speak out. And your messaging on behalf of patients is resonating.”
Testoni yesterday also repeated what she said in February during the coalition’s winter meeting that court decisions about manufacturers’ 340B contract pharmacy actions “take time and may have outcomes that can’t be predicted with certainty.”
“As I’ve said before, and I’ll say it again, I continue to believe if one of the pathways to a solution for this problem involves federal legislation, we will be prepared to pursue it.”
HRSA Administrator Johnson, like Testoni, encouraged covered entities to tell how 340B discounts translate into better patient care.
HRSA’s 340B program violation letters to manufacturers that impose conditions on 340B pricing when entities use contract pharmacies and HRSA’s other policy and oversight actions “are rooted in ensuring the program is doing what it is intended to do and reaching the people it was intended to serve,” Johnson said.
“It’s really important to us, and it’s really important to you all … that you tell the story of 340B,” she said. “I’ll be frank with you. We probably don’t have as much data as we need to be able to do that. We need more data, we need more information, and that, you will see in our budget proposal, really focuses on the importance of ensuring that we get data and information about the use of services so that we, again, ensure that we can have appropriate oversight and accountability.”
“Short of that—you know, that will, that is, work with Congress and things that will happen with Congress—in the meantime we really encourage you to collect and document data on your savings so that we can improve program integrity across the board, and we can continue to demonstrate the effectiveness of the program,” Johnson said. “That is the way we are going to be able to tell the story of how the 340B program is stretching scarce resources in order to ensure that the population has access.”
“The other part of the story is enforcement and ensuring that … all sides of the equation and everyone who participates in the program is living up to the goal of accountability,” she continued. “Which is why you have seen us continue to review actions on the contracting pharmacy services side and continue to, where appropriate, issue violation letters, and to continue to, where appropriate, make referrals to the Office of the Inspector General. And, where appropriate, to defend those actions in court. And we are pleased to see some of the courts have continued to affirm where we are. We haven’t won everything, but we have won some of these cases that have continued to affirm our authority.”
“All players in the system need to be fully accountable and transparent so that we can … best tell the story of this program and what it is doing and how it meaningfully is delivering services in communities across the country.”
OPA Director Egwim too said it was important for 340B covered entities to hone their storytelling skills.
“Your stories are important,” he said. “Your stories are about people—they are about your teams and the patients you serve. Consistent with the underlying congressional intent of the 340B statute, people give purpose and value to this program. Likewise, the 340B program is one of several in HRSA, an agency whose mission is in part to improve health outcomes and achieve health equity through access to quality services, and includes programs that provide equitable health care to people who are geographically isolated and economically or medically underserved. So please continue to share your stories, as this information is critical to reinforcing the importance of the program.”
Egwim also used the occasion to tell his own story to the audience, most of whom were seeing and hearing him for the first time.
“As a pharmacist with several years of community pharmacy practice serving the everyday people of Maryland, Washington, D.C., and Northern Virginia, I can relate to the feeling of having a patient look me in the eyes, and sadly express in fear, that they will have to go without treatment because they cannot afford the cost of their medication,” he said. “I am a pharmacist through and through in the practical sense of the profession. So I understand the pressures, and importance of the role that the 340B program plays in facilitating access to medication for people across the nation.”
“I understand the role that federal programs play in safeguarding access to care on the ground,” Egwim said, recapping his career as a U.S. Public Health Service officer. “As no stranger to the dynamics of the pharmacy industry, as well as that of drug pricing, I appreciate the important role the 340B program has continued to play in bolstering our national safety net.”
“As Director of the Office of Pharmacy Affairs, I will continue to prioritize initiatives that ensure and improve program compliance, and streamline processes both for covered entities, and manufacturers, while seeking out opportunities to amplify stories about the good work being done as a result of the 340B program,” Egwim said.