340B Providers Contemplate the Challenges Met and Prepare for the Ones Ahead

by Admin | March 11, 2021 2:21 pm

By Maureen Testoni

March 11, 2021– In this pandemic-focused world we all find ourselves in, it seems only fitting that one of my highlights of this past month was getting the chance to meet Fauci.

No, I’m not talking about the esteemed Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, who has become a household name over the past year. I’m talking about Fauci, the adorable rescue dog that belongs to former Health and Human Services Secretary Donna Shalala. The puppy made an appearance near the end of my conversation with the secretary at the recent 340B Coalition Winter Conference[1].

We have become accustomed to living our professional lives over video, seeing these kinds of glimpses into the home offices and family lives of the people we interact with at work. It is just one of the many ways in which we in the 340B drug pricing program community have had to adapt to the new reality while continuing to advance our missions to the patients who rely on 340B for the health care they need.

But challenges are nothing new for 340B or the people who live in its world. They have existed since the program came into being just a couple of months before Shalala started her eight-year tenure as HHS chief in January 1993. They continued to crop up during the years that her department oversaw its evolution into one of the most important parts of the nation’s health care safety net. And new challenges emerge even today.

Trials on Multiple Fronts

The hundreds of professionals representing hospitals, health centers, and clinics that attended this year’s Winter Conference are no strangers to such trials. In my opening remarks to attendees, I noted how 340B covered entities throughout the U.S. have been an integral element of the COVID-19 response and now are helping to execute the most ambitious vaccination campaign in our nation’s history.

And while a global pandemic would be more than enough of a crisis to deal with on its own, 340B covered entities also have had to contend with new attacks on the 340B program. Drug companies are refusing to offer discounts on drugs dispensed at community-based pharmacies, as required by the 340B law, and they have gone to federal court to fight the government’s enforcement of that law. Manufacturers also are exploring a unilateral overhaul of how 340B discounts work, pursuing fundamental changes that would impose major financial and operational burdens on covered entities.

But as 340B has come under more duress, covered entities and their allies have met the conflict straight on. The chorus of support for 340B against drug company attacks now numbers thousands of providers, scores of patient organizations, more than half of the members of Congress, and more than half of the states’ attorneys general. This united response has put enormous pressure on the manufacturers and on the federal regulators who have the responsibility to put a stop to their actions.

The fight over this issue is not over, and health care safety net champions will continue to speak with one powerful voice to seek the correct outcomes.

Laser-Focused on the Mission

Of course, COVID-19 and drug industry attacks were not the only topics on the minds of Winter Conference attendees. The mission of caring for patients with low incomes and those in rural areas requires a laser focus. And in numerous sessions, attendees discussed and shared best practices for running compliant and effective 340B programs at their hospitals, health centers, and clinics.

Conference sessions focused on the latest intelligence about 340B operations, compliance, and advocacy. Health Resources & Services Administration (HRSA) Director Krista Pedley gave attendees her biannual program update, discussing some of the regulatory changes the agency has made in the past year in response to the pandemic. Covered entities shared their data and their stories about how they have used 340B savings to serve their patient communities for both COVID and non-COVID health care needs.

As the body of knowledge and the body of research about 340B continues to grow, so does the ability of covered entities to apply the program where it will have the maximum benefit. The conference is a striking demonstration of how united the 340B community is in its commitment to serve the best interests of the patients who rely on it.

On the 2021 Horizon

Even as we reflected at the Winter Conference at the progress we have made and the challenges we have met, we acknowledged that this year could bring some of our toughest tests to date. The harm that the drug company attacks on 340B are causing for patient care cannot be understated.

But with a new Congress and a new administration, we have new opportunities for the 340B community to work with elected officials and their staff on protecting 340B and the hospitals, health centers, and clinics who rely on it. Drug pricing continues to be a major policy issue in Washington, and that will require the community’s diligence to ensure that any legislation or regulation in that area maintains the strength of the health care safety net.

To be successful in this task, we must continue educating and advocating on important 340B matters. Policymakers need to see the data and understand the context on the vital role that the program plays in providing care to patients who need it the most.

In our conversation at the conference, former HHS chief Shalala urged attendees to share their 340B patient care stories with policymakers during meetings and through social media.

“Keep putting a human face on the program,” she said. “That human face will resonate with both parties. The program saves lives and keeps institutions healthy.”

I think Fauci would agree with that sage advice.

Maureen Testoni is the President and CEO of 340B Health

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  1. 340B Coalition Winter Conference: https://www.340bwinterconference.org/
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