Millions of dollars are at stake as HRSA revises hospital eligibility criteria, requirements for contract pharmacies and the program's definition of “patient,” described as a patient with an “established relationship” with the provider. Only those patients are supposed to receive the discounted drugs. The rule is under review at the Office of Management and Budget.
“Signals point to a reining in of the program, and the most visible way for HRSA to do that is through the definition of 'patient,' ” said Billy Wynne, a partner at the lobbying firm Thorn Run Partners in Washington.
In 2007, HRSA issued proposed changes to the program but never finalized them after receiving critical public comments. At that time, the Safety Net Hospitals for Pharmaceutical Access, a trade group for hospitals enrolled in 340B, expressed concern about a provision that required hospitals to document whether they expected covered patients to come back within a year.
“It could be that (HRSA) will come out again with something similar,” said Maureen Testoni, general counsel for the group.
Enrollment in the 340B program has gone from 1,143 participating hospitals in April 2007 to 2,111 as of last month. Much of that growth stems from a provision in the Patient Protection and Affordable Care Act expanding 340B eligibility to children's hospitals, free-standing cancer hospitals, critical-access hospitals and rural referral centers, and sole community hospitals.
The drug industry-backed Alliance for Reform and Integrity is lobbying for a definition of “patient” that would require 340B providers to use savings directly for low-income and uninsured patients.
Hospitals note, however, that the 340B law allows them to use savings from the program to improve their overall financial and operational health to better serve all patients.
Follow Jaimy Lee on Twitter: @MHjlee