The Senate 340B Working Group is soliciting additional stakeholder input on key longstanding issues surrounding the Medicare 340B program. The discussion bill aims at clarifying the program’s intent in several key areas such as:
(1) Contract Pharmacies
The proposed bill would establish statutory clarity regarding how contract pharmacies partner with covered entities to dispense 340B drugs. Specifically, the proposed bill seeks to prevent drug companies from imposing restrictions on contract pharmacies and would mandate that drug makers must offer covered entities the 340B price for outpatient drugs, regardless of whether they are dispensed at a contract pharmacy or at an in-house pharmacy.
(2) Off-site Locations
Under the proposed legislation off-site hospital locations, also referred to as “child sites,” would need to be wholly owned by, and clinically and financially integrated with, a covered entity. Covered entities would be required to register “child sites” with the Department of Health and Human Services Secretary and publicly list these sites as part of their operations.
(3) “Patient” Definition
The bill also attempts to develop an official definition for what constitutes a “patient” in the 340B program. Senators are soliciting feedback on several considerations, including factors that should inform whether the covered entity has a meaningful relationship with a patient, and whether the patient definition should include a requirement to determine when the patient is first identified as a 340B patient.
(4) User fee program
The draft legislation also proposes the creation of a user fee program to provide the Health Resources and Services Administration (HRSA) with the necessary resources to conduct proper oversight of the 340B program. Specifically, the bill would direct the HHS Secretary to initiate such a program and require all 340B-covered entities to pay a fee equivalent to no more than 0.01% of the savings they receive.
The bill also includes provisions aimed at enhancing transparency, integrity and equitable treatment within the operations of the 340B program.
View the discussion draft explanatory statement and supplemental RFI
View the letter to 340B stakeholders
View the SUSTAIN 340B Act
Last Updated on February 8, 2024 by Aimed Alliance
