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As our Apexus Answers—Lessons Learned blog series comes to an end, we leave you with our last three cases that stood out as lessons learned. If these cases spark questions of your own, please don’t hesitate to reach out to us at Apexus Answers. The call center operates as part of our agreement with HRSA as the 340B Prime Vendor.

Read Part I of this series here, and Part II here.

Future Encounter Dates

A 340B consulting firm, on behalf of a federally qualified health center (FQHC) client, contacted Apexus Answers with a contract pharmacy-related inquiry. The FQHC would like to qualify a prescription as 340B through its contract pharmacy based on a future qualifying patient encounter date. For example, a patient is seen at an emergency room of a hospital that does not have a relationship with the FQHC. During the emergency room visit, the patient is issued a prescription for an inhaler. The patient fills the prescription at a contract pharmacy of the FQHC. A week after the emergency room encounter, the patient is seen for follow-up care at the FQHC. The FQHC provider determined that the inhaler prescribed by the hospital was in fact the best course of action to be continued. Could the inhaler prescription have been filled as 340B by the FQHC contract pharmacy even though the encounter at the FQHC was on a date after the inhaler was prescribed by the hospital provider and filled by the pharmacy?

Resolution: It is recommended that the FQHC have auditable records in place to demonstrate that the patient definition is met. As a best practice, an example of documentation for a 340B prescription resulting from an outside provider is an outbound referral request and a summary of the referral visit in the patient’s medical record.

Outcome: Apexus Answers effectively communicated how to apply the 340B patient definition, within the contract pharmacy setting, to the 340B consulting firm so that it could advise the FQHC appropriately. The consulting firm was also able to advise the FQHC to update its policies and procedures to reflect compliant practices.

New Child Site

A DSH entity is opening a new provider-based clinic that would begin servicing patients at the end of 2018. However, because the new facility is not a reimbursable clinic with outpatient costs/charges on the hospital’s currently filed Medicare cost report (MCR), the hospital was not able to register this new clinic on the OPAIS database until it meets 340B clinic eligibility requirements. The hospital contacted Apexus Answers to determine what account should be used to purchase the medications for the new clinic until it becomes eligible for 340B, which could be as early as April 2019.

Resolution: The hospital buyer began a webchat with an Apexus Answers call center specialist to inquire about the new clinic. The specialist first asked about the location of the clinic, which would help determine the purchasing option. The buyer confirmed that the clinic is located at a different physical address than the parent hospital. Certain off-site outpatient facilities of the hospital may use a GPO for covered outpatient drugs if:

1. The off-site outpatient facilities are located at a different physical address from the parent.
2. They are not registered on the 340B OPAIS.
3. They purchase drugs through a separate pharmacy wholesaler account than the parent.
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 340B OPAIS.

Outcome: The DSH entity contacted its wholesaler and set up a separate GPO account for the new clinic. It will continue to purchase the medications for the clinic on the new GPO account until the clinic appears on a reimbursable line on the most recently filed MCR and is able to register on the 340B OPAIS during an open registration period. Once the clinic appears active on the 340B OPAIS, it will be able to purchase 340B medications for its eligible patients but will be subject to the GPO Prohibition, as well as all other 340B Program requirements.

Compounded Sterile Preparations

An independent external auditor was conducting an audit of a children’s hospital and noticed a GPO contract being used when purchasing compounded sterile preparations (CSPs) from a 503B compounding center in town. Because children’s hospitals are subject to the GPO Prohibition, the auditor was concerned this hospital was violating 340B requirements when it bought these CSPs on the GPO contract.

Resolution: The Apexus Answers specialist responded that a GPO could not be used for covered outpatient drugs. The specialist provided the definition of covered outpatient drugs (CODs) in section 1927 (k) of the Social Security Act. In the scenario posed by the auditor, the children’s hospital was purchasing the final compounded product directly from this compounding facility (rather than purchasing components of the compounded product and sending them to the compounding facility for compounding). These compounded products were given new NDC numbers by the compounding facility that were not part of the Medicaid Drug Rebate Program, and did not meet the definition of covered outpatient drugs. Because these products were not covered outpatient drugs, the children’s hospital purchased them using a GPO.

Outcome: Because the GPO Prohibition applies only to covered outpatient drugs, the entity may purchase these non-CODs at the GPO price point. Going forward, the auditor knows how these specific CSPs are classified and can update their auditing methods to accommodate this information.

We hope that highlighting some of these interventions and lessons learned through interactions with the Apexus Answers call center helps answer common questions you may have.

Apexus Answers is a HRSA-aligned resource where you can submit your questions 24/7—contact us today! For additional clarification on 340B policy, search HRSA’s 340B frequently asked questions (FAQs) on the 340B Prime Vendor Program website and on the HRSA website.