March 9, 2012—Hospital senior executives responsible for their institution’s enrollment in the 340B program will receive an email from the Office of Pharmacy Affairs (OPA) on either April 9 or April 23 containing the username, password, and instructions they will need to personally recertify that their hospital and all of its registered outpatient sites are eligible for the drug discount program, according to a representative of the Pharmacy Services Support Center (PSSC).
Hospitals that do not recertify their eligibility will be removed from the program, OPA has said.[ms-protect-content id=”2799″] Safety Net Hospitals for Pharmaceutical Access (SNHPA), which represents hospitals enrolled in 340B, has been strongly encouraging hospitals to update their contact information in OPA’s covered entity database to guard against missing the recertification email message.
Details about the mandatory hospital recertification initiative emerged during a March 1 session at the 340B Coalition winter meeting in San Diego and a Feb. 28 OPA webinar.
In January and February, OPA advised hospitals to make all necessary changes to their entries in the 340B covered entity database by March 1 “to avoid significant delays” in the recertification process.
At the 340B Coalition meeting, Lisa Scholz of HRSA’s Pharmacy Services Support Center (PSSC) clarified that hospitals that missed the March 1 target date can still submit 340B covered entity database change request forms. She emphasized, however, that these forms must be submitted by an “authorizing official,” which OPA defines as “someone who can bind the organization to a contract, such as the CEO, CFO, COO, Executive Director, President or Vice President of the hospital.” Forms submitted by a pharmacy director or anyone else other than one of these types of executives will not be processed, she said.
During the Feb. 28 webinar, an OPA official said while someone at a hospital knowledgeable about its 340B program could complete the change request form, it would still have to be signed by the hospital’s authorizing official if submitted in paper form or be sent from the official’s email address if submitted electronically.
OPA also said during the webinar that some types of change requests would first have to be reviewed and might need extra documentation. One example is when a hospital’s name has changed. It is unclear how long it will take OPA to make these changes, even if a hospital submitted its request by March 1.
On either April 9 or April 23, hospital officials responsible for their institution’s 340B enrollment will receive an email from OPA with the username, password, and instructions they will need to actually complete the recertification process. These emails will be sent to the authorizing officials only.
When the authorizing official logs in, he or she will see the information OPA has on file for the main hospital and its enrolled outpatient facilities. The official will have to make additions and updates, if necessary. Because OPA requires more information than in the past, hospitals that enrolled long ago might have to add information. During the webinar, the OPA speaker observed that recertification probably would go more smoothly and be completed more quickly for hospitals that updated their database entries in advance.
During the 340B Coalition conference, Ms. Scholz explained that the recertification login information that hospitals will receive “is good only one time, there is no going back and there are no edits.”
“Once you hit the submit button, you will then have your recertification in process,” she said. This, however, does not necessarily mean that a hospital’s recertification has been accepted, she said. “Your authorizing official might be asked for additional validating information.”
The Feb. 28 webinar also addressed the following topics:
- Hospitals cannot register pharmacies as covered entities sites as they once were allowed to do. If a pharmacy resides in a clinic, the clinic should be enrolled. Stand-alone pharmacies should be dis-enrolled as covered entities and evaluated to determine whether they should be re-enrolled as ship-to sites for the hospital.
- It is important for hospitals to update information for each child site even if they have updated the same information for the parent site. For example, if information about the authorizing official is updated in the hospital’s entry in the database only, it will not automatically be updated in the child sites’ entries.
- Hospitals that know of changes occurring between now and April that need to be reflected in the database may submit change requests now indicating when the changes are scheduled to occur.
Another webinar on recertification will be held on a date to be determined. Questions about recertification may be sent to 340b.recertification@HRSA.gov.[/ms-protect-content]