A provision in the Affordable Care Act expanded the types of hospitals that are eligible to participate in the 340B program, which provides discounts on outpatient drugs to hospitals. The newly eligible hospitals include some free-standing cancer hospitals, rural referral centers, sole community hospitals, critical-access hospitals and children's hospitals.
HHS said the goal of the proposed rule is provide clarity, maintain savings for the newly eligible hospitals and protect the “financial incentives” of the companies that manufacture orphan drugs.
Safety Net Hospitals for Pharmaceutical Access said in a statement that, while the proposed rule is a “reasonable interpretation,” the “underlying provision in the law is fundamentally flawed.” It added that excluding price cuts on orphan drugs will discourage rural and free-standing cancer hospitals from enrolling or fully benefiting in the 340B program.
HHS said that as of Oct. 1, only 337 out of the newly 1,500 eligible hospitals have enrolled in the program. It also said the proposed rule is the first in a series of regulations that will address the orphan drug exclusion for the newly eligible hospitals.
Comments must be submitted by July 18.