The Florida Association of Community Health Centers (FACHC) today called on Congress and federal agencies to stop drug manufacturers’ efforts to limit access to affordable medications for uninsured and underinsured populations.

The not-for-profit organization released the following statement from its President and CEO, Andrew Behrman:

“Drug manufacturers have joined the ranks of pharmacy benefit managers (PBMs) to destroy one of the very best-intended programs from the federal government. They have become increasingly emboldened in recent months by inaction at the national level in how they choose to address perceived slights in the 340B Program. What was designed by Congress to provide up-front discounts to safety net providers for medications that save lives and control chronic conditions (such as asthma, diabetes, and heart disease) is now under attack not only from the middlemen like PBMs who try to scoop out these savings from the safety net and keep them for themselves, but also from the manufacturers. These discounts are, for many Community Health Centers, a lifeline used to keep providing services to the most vulnerable population in the state and across the country.

“With efforts that will directly endanger the safety net, the manufacturers are now looking for covered entities such as Community Health Centers (CHCs) to voluntarily accept rebates in place of discounts. For some CHCs, this means that they will have to front more than 10% of their budgets to the manufacturers in hopes that they will be reimbursed what they are owed by federal statute at some point in the future. Not only does this take away much-needed resources from direct care and access to doctors, dentists, therapists, and pharmaceuticals, but it also results in increased costs to the CHCs, as they must increase their administrative burden to monitor the rebates they are owed to make sure they are actually paid. It also puts a center at serious risk if the manufacturer decides to simply not pay the rebate. For CHCs, that means a program designed to stretch scarce federal resources will turn into a poison pill that closes many of their doors. And all of this during a global pandemic where Florida’s Community Health Centers are providing front-line testing, treatment and services to tens of thousands of COVID patients.

“Manufacturers are either announcing their new self-serving policy of only selling 340B drugs to in-house pharmacies or demanding submission to new on-line portals for sensitive claims data. These manufacturers are not entitled to this data and cannot guarantee it is protected, shifting the responsibility for a possible data breach onto the CHC that submits the data.

“To be fair, not all drug manufacturers have sent letters informing CHCs of these intents. But those that have done so are increasing in number and frequency, to the extent that unless Congress and the Health Resources and Services Administration (HRSA) – the agency under HHS charged with overseeing the 340B drug discount program – take action, this program may be killed under the weight of self-serving, selfish manufacturers and PBMs and it will assure that prices at the counter quickly skyrocket for millions of Americans.

“Recently, HRSA announced that it believes it lacks the authority to prevent manufacturers from taking these actions. After 24 years of asserting that it possesses such authority, this reversal has served to strengthen the manufacturers’ resolve to increase their own profits at the expense of the patients for whom the CHCs provide a lifeline. In establishing the 340B program in 1992 and expanding it in 2010, Congress never intended that for-profit manufacturers be given free rein to manipulate the financial and operational intent of this important program.

“The 340B program was written to provide a discount to the safety net when purchasing medications that is then passed on directly to the patient – not to allow manufacturers and their vendors to only offer rebates an unknown time later. Without immediate intervention on behalf of the 340B program and the community health centers and the millions of patients they serve, this program is in dire threat of being lost to corporate greed and profits.

“FACHC calls on Congress, HHS and HRSA to stop these manufacturers from independently restructuring this program, taking away earned 340B savings for patients, and restrict actions that thwart Congress’ and the agencies’ oversight responsibility and statutory intent. These actions undermine the integrity of the340B program and directly threaten access to the care our Community Health Centers provide to the most vulnerable patient populations.”

About the Florida Association of Community Health Centers (FACHC)

The Florida Association of Community Health Centers is a not-for-profit organization of Federally Qualified Health Centers that receive funding through the Health Resources and Services Administration Bureau of Primary Care and participate as covered entities in the federal 340B drug discount program. Learn more at www.fachc.org.