April 21, 2012—The Office of Pharmacy (OPA) updated its frequently asked questions (FAQ) webpage yesterday with guidance for hospitals about recertifying their eligibility for 340B drug discounts.
For the most part, the eight new FAQs address questions that came up during OPA’s Feb. 28 and March 28 webinars on recertification, which began on April 20 for free-standing cancer hospitals, children’s hospitals, rural referral centers (RRCs), and sole community hospitals (SCHs) and will begin on April 27 for disproportionate share (DSH) hospitals and on May 4 for critical access hospitals (CAHs).[ms-protect-content id=”2799″]
The new FAQs are as follows:
Q: What outpatient facilities are hospitals required to register on the 340B database?
A: In order for off-site outpatient facilities to purchase 340B drugs and/or provide 340B drugs to its patients, they must be listed on the 340B database. OPA will verify the eligibility of each off-site outpatient facility by using the hospital’s most recently filed cost report. All clinics located off-site of the parent hospital, regardless of whether those clinics are in the same building, must register with OPA as child sites of the parent 340B-eligible hospital. If an outpatient facility is only providing referral services for a covered entity, the requirement to register that outpatient facility with OPA would not apply. However, the outpatient facility that is providing referral services cannot purchase or dispense 340B drugs.
Since 1994, HRSA’s policy has been to use the most recently filed Medicare cost report for purposes of determining 340B eligibility for outpatient facilities (59 Fed. Reg. 47884 (Sept. 19, 1994)). In order for off-site facilities to become eligible for the 340B program, a covered entity’s most recently filed cost report must show that each outpatient facility is an integral part of the hospital and included as reimbursable on the covered entity’s Medicare cost report. OPA requires that the most recently filed cost report is submitted with the enrollment package in order to verify eligibility. Registering all off-site outpatient clinics with OPA will ensure that each clinic has been reviewed and verified by HRSA OPA as eligible to participate in the program, therefore alleviating any potential for providing pharmaceuticals to ineligible clinics or patients.
Q: Do clinics/departments located within the four walls of a registered 340B hospital have to be registered in the OPA database?
A: Outpatient clinics/departments within the four walls of the registered 340B hospital do not need to also register/enroll into the 340B program. However, the covered entity remains responsible for demonstrating that those outpatient clinics/departments on site are only using 340B discounted drugs for eligible outpatients, meet all 340B program requirements, and maintain auditable records.
Q: I was told that we cannot list our in-house pharmacy as a child site. Is that correct?
A: Pharmacies are not eligible 340B covered entities and therefore, should not be listed as a child site with a 340B ID in the database. If the site is only a pharmacy and is listed as a covered entity with a 340B ID, this pharmacy must be terminated from the database. It should then be determined whether it is appropriate for the pharmacy to be added as a “ship to” address for the actual covered entity in the database.
If the pharmacy is located within an offsite outpatient facility that also provides healthcare services and provides 340B drugs to its patients, the outpatient facility must be registered as a child site with the pharmacy listed as a “ship to” of that outpatient facility. When a pharmacy is supporting multiple child sites of a parent entity, the pharmacy should be listed as a “ship to” address under the parent’s 340B ID.
Q: My covered entity has a few physician clinics, do we need to register them as child sites?
A: It depends upon what is meant by physician clinic, as private physician offices are not eligible to participate as part of a hospital in 340B. Only hospital outpatient facilities that appear as reimbursable outpatient cost centers on the hospital’s most recently filed Medicare Cost Report are eligible to be listed and participate in 340B.
HRSA OPA requires that each hospital register all of its eligible, off-site outpatient facilities. This will ensure that each facility has been reviewed and verified by HRSA OPA as eligible to participate in the program, therefore strengthening the hospital’s compliance efforts.
Q: Is my covered entity required to submit our Medicaid/NPI number to the database?
A: If a covered entity bills 340B drugs to Medicaid it must provide that Medicaid billing number to the Office of Pharmacy Affairs to ensure against duplicate discounts. For further clarification on whether to submit your Medicaid/NPI number please review the Medicaid Exclusion Tutorial at: http://www.hrsa.gov/opa/medicaidexclusion.htm#tutorial
If a child site bills under a different Medicaid Provider Number or NPI than the parent site, those need to be appropriately listed with the child sites.
Q: Am I required to fill out a change request form for recertification if my covered entity has no necessary changes to be made in the 340B database?
A: No change request form will be required.
Q: My hospital covered entity submitted a change request form, does this mean we are recertified?
A: No. A change request form only updates the covered entity’s information in the 340B database. Recertification is a separate process that will require the covered entity’s authorizing official to update hospital information if necessary and certify to compliance with program requirements during a specified time period. The hospital’s authorizing official is responsible for ensuring program compliance for the covered entity. Recertification will cover the organization (parent) and all registered outpatient (child) sites in the program database. OPA, however strongly recommends that you update the database using the change request form prior to recertification to ensure a smooth recertification process. It is the covered entity’s responsibility to keep all information in the 340B program database up to date at all times. The program database is the sole source for covered entity and manufacturer information.
Q: During recertification will the authorizing official and primary contact receive emails?
A: The authorizing official and primary contact will receive an email from OPA with the date that recertification will begin. On the start date, only the authorizing official will receive the required user name and password to perform recertification.[/ms-protect-content]