May 7, 2015 -- New draft guidelines for the 340B discount drug program are under review at the White House Office of Management and Budget (OMB), a final step needed before the Obama administration reveals the much anticipated oversight framework.
Administrators of many hospitals and drugmakers have been at odds about expanding program. Hospitals, clinics, and other participants saved about $3.8 billion on the cost of medicines in fiscal 2013. The program was created in the 1990s with a goal of helping hospitals that treat many people living in poverty. Participants have complained about a lack of transparency about drugmakers' prices, while others have criticized a lack of rules on who should benefit from the discounted medicines.
"The 340B Drug Pricing Program's omnibus proposed guidelines address many key programmatic policy issues, including the eligibility of hospitals and outpatient facilities, patient definition, contract pharmacy and manufacturer compliance," said a spokesman for the Health Resources and Services Administration (HRSA), the division of the Department of Health and Human Services that administers the program, in a statement to CQ HealthBeat.
HRSA expects that it will be able to publish the 340B guidelines in the Federal Register, with a 60-day comment period allowed, once OMB completes its review.
HRSA last year had to abandon an attempt to create a sweeping set of rules for the effort. The agency in November 2014 withdrew a proposed regulation that it had advanced as far as the stage of OMB review. It opted then to try to resolve disputes about the program through a guidance document.
HRSA had had a setback earlier in 2014 when a federal court found against its ability to make a rule related to a section of the 340B program that covered orphan drugs.