Effective October 1, 2012, the Health Resources and Services Administration, Office of Pharmacy Affairs moved the deadline for 340B program registration of new covered entities and additions of outpatient facilities from 30 days before the start of each quarter to approximately 75 days before the start of each quarter.
The new registration periods for new covered entities and the addition of outpatient facilities will be: January 1 -- January 15 for an effective start date of April 1; April 1 -- April 15 for an effective start date of July 1; July 1 -- July 15 for an effective start date of October 1; and October 1 -- October 15 for an effective start date of January 1. 340B covered entities will not be permitted to register outside of these periods.
The 340B program regulations permit covered entities to contract with pharmacies to provide 340B pharmacy services to the covered entity's patients. Historically, these contract pharmacies have not been subject to the 340B program registration deadlines. As of October 1, 2012, new contract pharmacies will be subject to the new registration periods.
The 340B program provides significant drug cost savings to organizations eligible for the 340B discounts, including Federally Qualified Health Centers (FQHCs) (including FQHC look-alikes, community health centers, migrant health centers, healthcare for the homeless programs, health centers for residents of public housing, Office of Tribal Programs or urban Indian organizations), disproportionate share hospitals, children's hospitals, critical access hospitals, freestanding cancer hospitals, sole community hospitals, rural referral centers, family planning projects receiving a grant or contract under Section 1001 of the Public Health Service Act, entities receiving certain grants for outpatient early intervention services for HIV disease, certain state-operated AIDS Drug Assistance Programs, certain black lung clinics receiving funds under the Black Lung Benefits Act, comprehensive hemophilia diagnostic treatment centers receiving funds under section 501(a)(2) of the Social Security Act, certain Native Hawaiian Health Centers, certain urban Indian organizations, certain entities receiving assistance under title XXVI of the Public Health Service Act and certain entities receiving funds under 42 U.S.C. § 247c for the treatment of sexually transmitted diseases or 42 U.S.C. § 247b for the treatment of tuberculosis.