Industry voices final concerns before 340B guidance is revised

The primary lobbying group for the 340B discount drug program has expressed deep concerns regarding some of the new proposed regulations in the "mega-guidance."

"We are concerned that many of the proposed rules would have a devastating impact, and were struck by how many hospitals raised serious concerns with the proposal," said Ted Slafsky, executive director of 340B Health, at a press conference held earlier this week. The organization also released the comments it sent to the Health Resources Services Administration (HRSA), which is formulating the new guidance.

The 340B program has come under scrutiny in recent years, as reports have surfaced that some hospitals resell their discounted drugs to insured patients for a profit, or for not providing enough charity care. The Government Accountability Office has recommended that the program remove some of the financial incentives. HRSA is issuing new guidance in part to provide some clarity as to how the program should operate moving forward.

The primary concerns regard whether hospitals would be reimbursed for drugs used for outpatient services, according to 340B General Counsel Maureen Testoni. As it stands, they could be barred from receiving discounts for treating cancer patients with infused chemotherapy drugs if they are prescribed outside of the hospital setting, or outpatient drugs when patients are admitted to the hospital for treatment. Outpatient drugs may also be barred from discounting when a patient is discharged.

Testoni suggested that this could have an impact on rural patients, forcing them to travel long distances to obtain fusion chemotherapy services, and it could even impact stroke patients receiving clot-busting drugs in the hospital ER.

"We call on the government to revise these rules so that providers can continue to benefit from the program and stretch resources to treat the underserved in their communities," Testoni said in a statement.

To learn more:
- read the 340B Health statement 
- check out the HRSA comments (.pdf)