This article was originally published on March 25th and was updated on April 23rd. It is being updated as new information becomes available.

We wanted to provide updates on the most recent HRSA announcements that could impact your 340B Program during the COVID-19 crisis.

340B Eligibility

HRSA recently announced that it “is allowing some entities, upon request and review, to immediately enroll in the 340B Program.”  The announcement did not clarify what requirements would need to be met for immediate enrollment in the 340B Program. However, HRSA encouraged the entities to contact the 340B Prime Vendor Program (888-340-2787 or apexusanswers@340Bpvp.com) for coordination of technical assistance. HRSA will review each request on a case by case basis to determine participation and will post a supplemental Medicaid Exclusion File (MEF) every Friday that includes a list of entities who have been approved for immediate enrollment. The MEF can be found here.

If a site does not meet the pre-COVID-19 eligibility requirements of being listed as reimbursable on the most recently filed Medicare Cost Report or having associated outpatient costs and charges, it could still be granted immediate enrollment. The entity would need to be able to provide details on its current response to the COVID-19 crisis and why immediate enrollment is needed. The FAQ from HRSA’s COVID-19 response is below:

We are seeing a surge in patients and need to expand our services to another site. Will any special exemptions be made for covered entities or any changes to the registration process?
To the extent a covered entity has a specific concern about 340B eligibility of a new site, the covered entity should contact the 340B Prime Vendor Program (1-888-340-2787 or apexusanswers@340Bpvp.com) and we will evaluate each circumstance on a case-by-case basis. In addition, please review the content at https://www.hrsa.gov/opa/COVID-19-resources for certain flexibilities during this time.

Telehealth Considerations

With the substantial rise in telehealth visits over the past few weeks, it is critical for entities to have updated policies and procedures to reflect how they are handling telehealth visits when determining 340B eligibility. The entities should maintain auditable records for each eligible 340B patient. The FAQ from HRSA’s COVID-19 response is below:

Given the coronavirus 2019 pandemic, what flexibilities are available to entities to allow a provider to offer telehealth services?
HRSA understands that the use of technology in health care delivery during this time is critical, and that telemedicine is merely a mode by which the health care service is delivered. For the 340B Program, HRSA recommends that covered entities outline the use of these modalities in their policies and procedures and continue to ensure auditable records are maintained for each eligible patient dispensed a 340B drug.

Medicare DSH Threshold

There is an effort to waive the Medicare Disproportionate Share Hospital (DSH) program ratio requirement during the public health emergency. This is only in discussion and has not been implemented.

Update from March 25, 2020

The current public health emergency has created circumstances where a covered entity’s COVID-19 response may affect its 340B Program’s compliance and eligibility.  HRSA states that while they cannot waive statutory requirements of the 340B Program, they do feel that there is flexibility in the interpretation of the requirements.  Below are a few highlights from the update:

• A covered entity in this public health emergency should continue to ensure it has policies and procedures in place to address the proper dispensing of 340B drugs and it must continue to keep auditable records.
• An abbreviated health record may be adequate for purposes of the 340B Program. The record should identify the patient, record the medical evaluation (including any testing, diagnosis or clinical impressions) and the treatment provided or prescribed.
• When utilizing volunteer health professionals to provide health care, emergency documentation should be generated to define the relationship between the provider and the covered entity and to clarify covered entity’s responsibility for providing care.
• Hospitals subject to GPO prohibition may use a GPO to purchase medications due to shortages and if it is unable to purchase the medication at either 340B or WAC. Hospitals do not need to report this information to HRSA under the COVID-19 public health emergency.
• HRSA will be moving towards conducting 340B audits virtually for the next several months.

The full update can be found at https://www.hrsa.gov/opa/COVID-19-resources.

We will continue to monitor the ever-changing impact of COVID-19 and work to provide additional updates. However, if you have any questions, please contact one of our 340B experts.

Please continue to monitor our Coronavirus Resources and Information Page and COVID-19 Relief & Operations FAQs for updates.