July 25, 2012—Beginning this fall, 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 yesterday.
HRSA issued the notice in final form and it will take effect Oct. 1, 2012. On its Web site, OPA said it will host a webinar on the new enrollment process in the coming weeks.[ms-protect-content id=”2799″]
During the recent 340B Coalition annual conference, Office of Pharmacy Affairs (OPA) Director Krista Pedley told program stakeholders that HRSA was considering making the change in order to free up staff for 340B program integrity efforts.
OPA adds providers and their outpatient sites to its 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.
“In situations where the 15th falls on a Saturday, Sunday, or federal holiday, the deadline will be the next business day,” the notice states. “Covered entities will not be able to submit registrations outside of these date parameters listed above except when the Secretary [of Health and Human Services] has declared a public health emergency.”
The policy change also has significant implications for 340B multiple contract pharmacy arrangements. Currently, OPA enrolls contract pharmacies in the drug discount 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.”[/ms-protect-content]