January 19, 2012—The Office of Pharmacy Affairs (OPA) has begun reminding hospitals enrolled in the 340B program that this spring they will be required for the first time to recertify that they are eligible to buy 340B-discounted drugs.
Just over 21 percent of sites enrolled in 340B belong to a hospital, ranking them third behind consolidated health centers (27 percent) and family planning centers (24 percent). Collectively, they are the biggest purchasers of 340B drugs.
[ms-protect-content id=”2799″]Hospitals began receiving the email reminders last week. Their delivery marked the latest stage in a process that began in October, when OPA initiated a phased-in approach to verifying all 340B covered entities’ eligibility, as mandated by the Affordable Care Act (ACA). Before health care reform, the only entities that needed to revalidate their eligibility every year were sexually transmitted disease (STD) clinics, tuberculosis (TB) clinics, and HIV/AIDS programs. Program-wide recertification began in the fall with Ryan White facilities, followed by STD and TB clinics and then Indian Health Service and family-planning clinics.
OPA addressed last week’s email messages to hospital officials who were responsible for completing and signing their institution’s 340B registration form. Copies were also sent to those listed in the OPA database as their institution’s primary contacts.
OPA reminded the officials who signed their hospital’s 340B enrollment forms that “you are responsible for ensuring program compliance for your entity.” Recertification, the email said, will cover parent hospitals and all of their registered outpatient sites and will be required for all hospitals that entered 340B before April 1, 2011.
“Please be aware that hospitals failing to participate in the recertification process or that no longer meet the program requirements will be removed from the program,” the email said.
Recipients of the email were directed to “visit the 340B program web site, review your hospital’s information and make any changes necessary.” For example, they were advised to make sure that addresses were correct, that facilities were still open and eligible, and that contact information was up to date.
“Recertification emails for hospital entities will begin in early April 2012,” the email continued. “The Authorizing Official will receive notification to recertify the covered entities listed under their control to include: username, password, and recertification instructions.” Those wanting to make changes were advised to visit http://opanet.hrsa.gov/OPA/HardcopyForms.aspx, complete the 340B participant change form available there, and email it back to OPA by March 1 “to avoid significant delay.”
The email said OPA will review all hospitals’ recertification this spring and added that it “reserves the right to request additional information to verify the 340B program integrity requirements.”[/ms-protect-content]