With Xavier Becerra in place as HHS secretary, 340B providers are hopeful he will act fast and decisively against drug manufacturers that have either stopped providing 340B discounts or placed restrictions on 340B pricing in the contract pharmacy setting. | Shutterstock

Becerra Expected To Usher in Sea Change to 340B Governance

Updated, Friday, March 19, 9:30 a.m. EDT—After what initially appeared to be a rocky path to confirmation and a deadlocked vote in the U.S. Senate Finance Committee, California Attorney General Xavier Becerra (D) was confirmed today, by a 50-49 vote, as the U.S. Health and Human Services (HHS) Secretary.

Although Becerra was considered too liberal by many Republican senators due to his longtime support of Medicare-for-all and abortion rights, moderate Senate Republican Sen. Susan Collins (Maine) voted for his nomination. Becerra received no other Republican votes. 

A key Republican lawmaker on health care policy, Sen. Bill Cassidy (R-La.), said Becerra’s unsatisfactory answers to his questions about the 340B program, in his estimation, demonstrated that Becerra is unfit to be confirmed. Cassidy’s assessment is not shared by 340B providers, Democrats, and some Republican lawmakers.

Becerra’s confirmation is a welcome development for 340B covered entities and is expected to reflect a 180 degree turn from the previous administration. President Trump’s HHS Secretary, Alex Azar, was highly critical of 340B providers and made 340B reform a key part of the administration’s health care agenda. Before serving as HHS Secretary, Azar was the U.S. President of drug manufacturer Eli Lilly, and earlier served as Lilly’s Senior Vice President of Corporate Affairs and Communications. Becerra is expected to be a champion for the 340B program and 340B covered entities.

One of Becerra’s first important decisions on 340B could be on whether to appeal a federal district judge’s decision on Monday that HHS disregarded procedural requirements when it finalized 340B administrative dispute resolutions rules in December, or whether to withdraw and re-issue the rule to correct procedural flaws that the judge identified.

In December, Becerra helped spearhead a bipartisan letter with the attorneys general of Connecticut, Nebraska, Kansas and 25 other states urging then Secretary Azar to hold accountable pharmaceutical firms that were refusing to provide discounts mandated by 340B.

“While Americans grapple with COVID-19, it is critical that we protect access to affordable care,” Becerra said at the time. “Discounts afforded under the 340B Drug Pricing Program are more critical now than ever. They ensure that low-income and uninsured patients have access to affordable medication as they deal with the substantial impact of the pandemic. We call on HHS to hold these non-compliant drug manufacturers accountable.”

During his Senate confirmation hearing last month, Becerra reinforced the notion he would support the 340B program in response to a question from Sen. John Thune (R-S.D).

“Absolutely. Not just in your rural communities, but in the inner cities I’ve had to represent who depend on 340B,” he said.

Becerra also said he supported an advisory opinion issued by HHS last December that rejected the arguments made by drug manufacturers that they are not required to offer 340B pricing on drugs shipped to contract pharmacies.

“The previous administration issued an advisory opinion, and we’ll try to build on the work that’s been done in the past,” Becerra said in response to a question from Sen. Jerry Moran (R-Kan.). “But what we must not do is sacrifice patients. They should not be the ones who suffer as a consequence of fights going on here. I will guarantee to you, if I am fortunate enough to be confirmed, I will sit down with you and others who are interested in addressing this issue because, 340B has become an indispensable program for some of these providers who are really helping some of our neediest populations.”

340B providers were also pleased with Becerra’s ability to parry tough questions from long-time 340B critic Cassidy.

“The attorney general has evidenced that he will be a strong supporter of the 340B program,” said Peggy Tighe, principal at Powers Law (a 340B Report sponsor) and counsel to Ryan White Clinics for 340B Access. “His history in Congress is also very strong evidence that, once confirmed, he will continue to be a champion for patients, the underserved, and safety net providers. As such, we are hopeful that he will act expeditiously to stop what many safety net providers consider to be a flagrant, widespread, and dangerous practices by certain manufacturers, PBMs, and insurers to undermine the 340B program.”

Entities and Manufacturers Congratulate Becerra

Groups representing 340B covered entities and drug manufacturers alike congratulated Becerra on his confirmation.

“Becerra brings to the Department of Health and Human Services a strong record of accomplishments as a champion for health care coverage and equity,” America’s Essential Hospitals said. “America’s Essential Hospitals looks forward to working with the new secretary and his team to enhance support for essential hospitals and underrepresented people and to protect programs vital to our health care safety net, such as Medicaid and the 340B Drug Pricing Program.”

The National Association of Community Health Centers said, “We appreciate that the Secretary brings to the leadership post notable expertise in health care policy, an established relationship with health centers and a solid understanding of the value of affordable primary care, especially in times of chaos and disruption. As a former Member of Congress from Los Angeles, and a member of the House Ways and Means Committee, Becerra used his office to further understand the mission of health centers from the ground up. As Attorney General of the State of California, he vigorously defended insurance coverage for millions of Americans. He also spearheaded efforts to protect the 340B low-cost prescription drug program, which is essential to health center efforts to provide affordable care to the poor and chronically ill.”

Pharmaceutical Research and Manufacturers of America president and CEO Stephen Ubl said HHS “plays an important role in protecting the health and well-being of the American people and has been a pivotal partner in our efforts to combat the pandemic.”

“I wish to congratulate Xavier Becerra for being confirmed to lead the department at this critical moment,” Ubl said. “We look forward to continuing our collaboration with the department under his leadership and working together to help address our nation’s leading priorities: getting COVID-19 under control and improving health care affordability and access for all Americans.”

Hospital group 340B Health tweeted: “Congratulations to @XavierBecerra on your confirmation as @HHSGov Secretary. We look forward to working with you to #Protect340B for safety-net hospitals and their patients! #340B”

AIDS Healthcare Foundation (AHF) President Michael Weinstein late yesterday today congratulated Becerra on his confirmation and swearing-in, saying, “in you we have a champion for people living with HIV who depend on HHS to provide leadership in public health.” Weinstein pointed to Becerra’s “defense of the 340B program against the recent attacks from drug manufacturers” while serving as California Attorney General. “340B is a vital part of our social safety net that costs taxpayers nothing,” Weinstein said. “Non-profit 340B covered entities depend on 340B savings to keep their doors open to the most vulnerable populations.”

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