October 16, 2014—The Health Resources and Services Administration has started asking its grantee health centers, specialized clinics, and Ryan White HIV/AIDS programs about their 340B compliance during site visits, and their answers could trigger “further investigation,” HRSA’s Office of Pharmacy Affairs announced in its latest monthly 340B program update. [ms-protect-content id=”2799″]
OPA Director Cmdr. Krista Pedley first mentioned the plan to add a 340B assessment in HRSA grantee site visits during a drug industry event last March. She said it would serve as a potential “trigger element” for a 340B program compliance audit and would cover about 500 covered entities annually.
“The goal of these visits is to maximize the reach of our program integrity efforts, while ensuring transparency for all stakeholders to understand 340B compliance requirements and site visit expectations,” OPA said in in the program update.
Under the heading “Site Visit Preparation,” the update describes attributes of “successful” covered entities, such as the ability “to efficiently and effectively prevent compliance issues and identify any material breach.” OPA also outlined how grantees should be prepared to share their organization’s 340B policies and procedures regarding patient definition, preventing duplicate discounts, and contract pharmacy.
HRSA staff visit health centers during the first year of their grant funding and then at least once per the remainder of the grant period or at least once every three years, according to an online guide to site visits for centers. [/ms-protect-content]