340B Hot Topics

Office of Pharmacy Affairs Update

Last month, in conjunction with the 340B Coalition Conference, the 340B Prime Vendor (PVP) hosted its biggest-ever “340B University,” an excellent training opportunity for staff working with the 340B Program on all levels of implementation. 

The University serves as an important reminder that HRSA and PVP are the only sources of information related to the 340B Program that are verified and endorsed by HRSA.

The responsibility to ensure compliance with 340B Program requirements rests solely with covered entities and manufacturers that participate. Information received from vendors, consultants and other third parties cannot be assumed to be compliant with HRSA policy. Therefore we recommend all information and guidance received from outside parties is verified by HRSA or PVP. 

This month, we’d like to highlight some of the most frequently asked technical assistance questions and the answers you should use in your work on the 340B Program in your hospital or clinic.

Referrals

If we refer a patient to an outside clinic, can we fill their prescriptions from our 340B clinic?
A covered entity may send a patient to an outside clinic not registered with 340B and consider that patient 340B eligible only if the 340B patient receives health care from a health care professional who is either employed by the covered entity or provides health care under contractual or other arrangements (e.g., referral for consultation) such that responsibility for the care provided remains with the covered entity (61 Fed. Reg. 55156 (October 24, 1996)). If the covered entity can document that it retained responsibility for the health care services provided to the patient, then that individual may be eligible to receive 340B drugs from the covered entity.

Outpatient Facilities

How does an entity determine which of its outpatient facilities that wish to use 340B drugs should be listed in the 340B Database?
The registration process for outpatient facilities has been significantly improved and automated; as of July 1, 2014, the 340B database offers a hospital a pre-populated list of outpatient facilities eligible for registration. The hospital can choose which facilities it wishes to register, and offer some basic financial information on each via web form. This process replaces the old system, which required a hospital to submit written documentation.  Under this new system, there may be occasions when a hospital must submit documentation; we strongly suggest you read the instructions carefully and utilize the Covered Entities Guide for Public Users (PDF - 292 KB)
as you complete the registration.  If you have feedback on the new HRSA process, please provide it via Apexus Answers, a service of PVP, via e-mail, phone or online chat.

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.  All clinics, services or departments located off-site of the parent hospital, regardless of whether they are located 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)). The outpatient facility is considered an integral part of the hospital and therefore eligible for 340B if it is a reimbursable facility included on the hospital’s most recently filed Medicare cost report. OPA strongly encourages hospitals to have copies of the latest filed cost report on hand to facilitate completion of their registration.

How does an entity register multiple service locations in place of currently registered clinic, in accordance with the clarified instructions released June 2014?
There are two steps an entity must take in order to register multiple services located within the same clinic.  First, the hospital must register the individual services/clinics during an open registration period. Second, they must terminate the active/current registration. Terminating the active registration can be done in one of two ways: (1) during recertification, or (2) at a date prior to the start date for the new registered service/clinics. Most importantly, hospitals must coordinate the start date of the new registrations with the ineligible date of the terminating registration.  For example, if the new registrations begin on October 1, 2014, the “date” tab of the terminating entity’s record should look like this:

  • Termination date: 10/1/2014
  • The date the entity became ineligible: 10/1/2014
  • Last date 340B drugs were or will be purchased under the 340B ID: (must be prior to 10/1/2014)

Transferring Medications

Can an eligible 340B entity transfer medication to another 340B participating site, if both are part of the same covered entity and/or the same health care system?
A 340B covered entity may transfer 340B drugs to any outpatient facilities that are an integral part of that covered entity. If the covered entity is eligible on the basis of a grant, the facility must be within the scope of the grant. In the case of 340B hospitals, the outpatient facility must be an integral part of the hospital that is listed on the most recently filed Medicare Cost report and registered on the OPA database, if required. On the 340B database, facilities that are part of a covered entity have the same 340B ID number as the parent/main entity and some sort of a suffix (letter or number) added to the end. Please contact Apexus Answers for specific questions.

However, a 340B covered entity is prohibited from transferring 340B Drugs to anyone other than a patient of that covered entity. Accordingly, one 340B covered entity cannot transfer a 340B drug to patients of a different covered entity. Under the statute, health care delivery systems to which an eligible 340B covered entity may belong are not included in the statute as eligible entities.

GPO Prohibition

Can our hospital, subject to the GPO prohibition, voluntarily opt out of participating in 340B purchasing for some of its clinics, and use a GPO in those clinics?
Hospitals subject to the GPO prohibition and their off-site outpatient clinic sites that are registered on the OPA 340B database as participating in the 340B Program are subject to the GPO prohibition and cannot purchase any covered outpatient drugs through a GPO or other group purchasing arrangement. A hospital subject to the GPO prohibition may not purchase covered outpatient drugs through a GPO for any of its clinics/departments within the four walls of the hospital (same physical address) under any circumstance. However, certain off-site outpatient facilities of the hospital may use a GPO for covered outpatient drugs if those off-site outpatient facilities meet all of the following criteria: 

  1. Are located at a different physical address than the parent; 
  2. Are not registered on the OPA 340B database as participating in the 340B Program; 
  3. Purchase drugs through a separate pharmacy wholesaler account than the 340B participating parent; and 
  4. The hospital maintains records demonstrating that any covered outpatient drugs purchased through the GPO at these sites are not utilized or otherwise transferred to the parent hospital or any outpatient facilities registered on the OPA 340B database.

08/04/2014

Date Last Reviewed:  April 2017


Hospital Recertification

All hospitals are required to recertify annually in order to attest that they are compliant with all requirements of the 340B program. Annual recertification of 340B program eligibility is a required condition of participation; failure to recertify will result in removal from the program. Hospitals should have the following available in order to be ready for recertification: 

  1. Most recently filed worksheet E Part A, Line 33, allowable DSH %; 
  2. EIN employer ID number; and
  3. Recertification user guide.  

Passwords will be issued August 6, 2014.