NEW Revised Timetables for Enrolling in 340B

Beginning fall of 2012, safety-net hospitals and other health care providers will have four 15-day periods per year in which to enroll themselves, their outpatient facilities, or their contract pharmacies in the 340B program, the Health Resources and Services Administration (HRSA) announced in the Federal Register. HRSA issued the notice in final form and it will take effect Oct. 1, 2012.

Providers and their outpatient sites are added to the 340B covered entity database on a quarterly basis, on Jan. 1, April 1, July 1, and Oct. 1. Under current policy, to obtain 340B pricing beginning on one of those dates, providers must apply at least one month in advance. For example, to become eligible for 340B discounts on Jan. 1, a provider must apply no later than Dec. 1.

Under the new system, the registration period for eligibility beginning Jan. 1 will run from Oct. 1 through Oct. 15. The other new enrollment periods are Jan. 1 through Jan. 15 for April 1 eligibility; April 1 through April 15 for July 1 eligibility; and July 1 through July 15 for Oct. 1 eligibility.

In addition, covered entities will now have to submit all supporting documentation for their own enrollment or that of child sites “on the same day as online registration is completed,” according to the notice. “Incomplete packages will not be considered,” it states. Under existing policy, providers submit their documentation subsequent to registration.

The policy change also has implications for 340B multiple contract pharmacy arrangements. Currently, OPA enrolls contract pharmacies in the program on a rolling basis, with wait times reportedly now running in the range of one to two months. Beginning this fall, providers will have to submit contract pharmacy enrollment applications during the same four 15-day periods as for 340B parent and child sites. Also, OPA will stop enrolling contract pharmacies as applications are processed and add them instead at the beginning of each quarter.

HRSA also said in the Federal Register notice that it will consider contract pharmacies registered only after “the registration form has been completed in its entirety and the original, signed copy is received.” The signed forms “are due to OPA [the Office of Pharmacy Affairs] within 15 days from the time online registration was completed” and “incomplete packages will not be considered.”

If you have any questions, please contact 340B Health Senior Manager of Policy and Compliance, Rebecca Swartz at rebecca.swartz@340bhealth.org or (202) 552-5852.