October 2, 2013—The Health Resources and Services Administration’s (HRSA) Office of Pharmacy Affairs (OPA) says it believes that 340B stakeholders should be able to continue to use the 340B online database for the duration of the federal government shutdown that began yesterday.[ms-protect-content id=”2799″] Health care providers need the database to enroll in the drug discount program, and yesterday was the start of one of the four 15-day periods during the year when providers can sign up.
Most federal offices were forced to close Oct. 1 because Congress did not pass a government-wide appropriations bill for fiscal 2014, which began yesterday. It is unclear how long the shutdown will last.
The 340B registration process takes place entirely online in the OPA website’s database section. Many federal agencies have closed their websites as part of the shutdown and HRSA was expected to follow suit. If HRSA had shuttered its website and the OPA database along with it, providers would not have been able to register Oct. 1-15 and begin accessing 340B pricing effective Jan. 1. The next chance to enroll is Jan. 1-15 for an April 1 start date.
“Due to the lapse of appropriations, [our] staff will be unavailable until further notice,” OPA said in a notice on its home page. “We believe the 340B database will remain online during this time, and that the system will be able to continue accepting covered entity and contract pharmacy registrations for the open registration period of October 1 through October 15, 2013.”
The OPA website and 340B database were still accessible as of this morning, Oct. 2.
As long at the database stays open, providers also can continue to send OPA requests to make changes in their database files, or to remove themselves, their sites, or their contract pharmacies from 340B. Changes in contract pharmacy status will be processed automatically during the shutdown, OPA said, “but covered entity registrations, change requests, or termination requests will not be processed or reflected on the database until HRSA is able to resume normal operations.”
OPA reminded manufacturers in the notice that they “must continue to sell 340B drugs to eligible covered entities listed on the database as of October 1, 2013.”
OPA is referring all requests for technical assistance to the 340B Prime Vendor Program at (888) 340-2787 or ApexusAnswers@340Bpvp.com.
OPA also told drug manufacturers in an email yesterday that it “is committed to ensuring that our industry partners are aware of entities that are terminated from [340B] on a quarterly basis.”
“While OPA staff will be unavailable until further notice due to the lapse of appropriations, we are attaching the list of covered entity sites with terminations effective on 10/1/2013,” OPA wrote. “Please contact 340Bpricing@hrsa.gov if you need any additional information, although we will be unable to respond until normal operations resume.”[/ms-protect-content]