HRSA is working to keep 340B Program participants and stakeholders updated on the latest information regarding the coronavirus disease 2019 (COVID-19).
All COVID-19 information related to the 340B Program will appear on this page, and we will update resources as they become available.
CDC Resources
340B Resources
HRSA understands that many 340B stakeholders are concerned about the evolving impact of the COVID-19 pandemic. The circumstances surrounding this public health emergency may warrant additional flexibilities, especially to affected 340B covered entities. To the extent a 340B stakeholder has a specific circumstance where they believe their COVID-19 response may affect their compliance or eligibility in the 340B Program, the stakeholder should contact the 340B Prime Vendor at 1-888-340-2787 (Monday – Friday, 9 a.m. – 6 p.m. ET) or apexusanswers@340bpvp.com. The 340B Prime Vendor will coordinate with HRSA technical assistance and evaluate each issue on a case-by-case basis.
HRSA is allowing some entities, upon request and review, to immediately enroll into the 340B Program. HRSA will post a supplemental Medicaid Exclusion File (MEF) (XLSX - 193 KB) every Friday, beginning April 10, 2020, that includes a list of entities who have been approved for immediate enrollment. This list is in addition to the quarterly MEF posted on the 340B Office of Pharmacy Affairs Information System.
Below are general flexibilities that covered entities should adhere to during this public health emergency.
Section 340B(a)(5)(B) of the Public Health Service Act prohibits covered entities from reselling or otherwise transferring a 340B covered outpatient drug to a person who is not a patient of the entity. In determining whether an individual qualifies to receive 340B drugs, HRSA believes that it is appropriate to take into account the realities of the COVID-19 pandemic. 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. During this time, 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. For purposes of 340B Program eligibility, the record may be a single form or note page. It is the recorded information that creates a record. For example, under these circumstances the patient may be without insurance cards or identity papers and providers may not have access to documented medical histories. In the current public health emergency, HRSA believes that self-reporting of identity, condition, and history are adequate for purposes of 340B recordkeeping requirements.
In addition, in a situation where volunteer health professionals are providing health care, emergency documentation should be generated to make the relationship between the provider and the covered entity clear and to make clear the covered entity’s responsibility for providing care. This documentation should recognize the emergency nature of the situation, the name and address of the volunteer, and their relationship to the clinic, and should be kept on file by the covered entity.
FAQs
Below are some general frequently asked questions (FAQs) related to COVID-19. If you have a question related to COVID-19 that we do not cover on this page or in the FAQs below, please contact the 340B Prime Vendor Program at 1-888-340-2787 or apexusanswers@340bpvp.com.
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Are hospital covered entities able to register offsite, outpatient facilities before being listed as reimbursable on their Medicare Cost Report?
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In order to register for the 340B Program and be listed on the 340B Office of Pharmacy Affairs Information System (340B OPAIS), HRSA must first verify that the offsite, outpatient facility is listed as reimbursable on the hospital's most recently filed Medicare cost report and has associated outpatient costs and charges as outlined in HRSA's 1994 Outpatient Hospital Facilities Guidelines (PDF - 1 MB)
HRSA notes that for hospitals who are unable to register their outpatient facilities because they are not yet on the most recently filed Medicare Cost Report, the patients of the new site may still be 340B eligible to the extent that they are patients of the covered entity. Learn more about HRSA's patient definition guidance (PDF - 31 KB)
These situations should be clearly documented in the covered entity's policies and procedures. In addition, a covered entity is responsible for demonstrating compliance with all 340B Program requirements and ensure that auditable records are maintained for each patient dispensed a 340B drug.
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Does HRSA have any plans to waive the statutory eligibility requirements pertaining to the disproportionate share adjustment percentage for certain hospitals during the COVID-19 pandemic?
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HRSA is unable to waive the disproportionate share adjustment percentage requirements that are set in the 340B statute for certain hospitals seeking to participate as 340B covered entities. Stakeholders are encouraged to review the content on this webpage for certain flexibilities during this time.
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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?
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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 on this webpage for certain flexibilities during this time.
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Will HRSA relax its standards around the definition of a patient for purposes of providing covered outpatient drugs to all who need treatment related to COVID-19?
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At this time, HRSA is unable to waive 340B statutory requirements, specifically the provision related to reselling or otherwise transfer the drug to a person who is not a patient of the entity, pursuant to section 340B(a)(5)(B) of the Public Health Service Act. However, please review the content on this webpage for certain flexibilities during this time related to recordkeeping.
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*REVISED* With the current situation of the COVID-19 crisis, will HRSA reconsider allowing hospitals subject to the Group Purchasing Organization (GPO) prohibition to purchase 340B covered outpatient drugs through a GPO? Will HRSA still require reporting upon use of a GPO? (Updated 3/23/2020)
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HRSA is unable to waive the 340B statutory requirements, specifically with respect to the Group Purchasing Organization (GPO) prohibition pursuant to section 340B(a)(4)(L)(iii) of the Public Health Service Act. Hospitals that are subject to the GPO prohibition include disproportionate share hospitals, children's hospitals, and freestanding cancer hospitals.
These hospitals may not use a GPO for covered outpatient drugs at any time, including private label products. However, if a hospital is unable to purchase a covered outpatient drug at the 340B ceiling price, the covered entity should first try to obtain the drug at wholesale acquisition cost (WAC). If it is also unable to purchase the product at WAC due to shortages, a hospital may use a GPO (or GPO private label products). Hospitals do not need to report this information to HRSA under the COVID-19 public health emergency. The covered entity should address these situations in their policies and procedures and it must continue to keep auditable records.
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Will HRSA allow manufacturers the ability to offer their private label drugs at the 340B ceiling price to all covered entities, including those who are subject to the GPO prohibition?
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To the extent a manufacturer with a 340B Program Pharmaceutical Pricing Agreement (PPA) has private label products that are covered outpatient drugs and the manufacturer has plans to make those private label products available to all covered entities at or below the 340B ceiling price, manufacturers are encouraged to contact HRSA directly at 340Bpricing@hrsa.gov so HRSA can work to ensure compliance of both the manufacturer and covered entities subject to the GPO prohibition.
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Given the coronavirus 2019 pandemic, what flexibilities are available to entities to allow a provider to offer telehealth services?
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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.
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*REVISED* Does HRSA plan to suspend or cancel audits based on COVID-19?
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HRSA will conduct 340B Program covered entity audits both remotely and in-person for Fiscal Year 2022. HRSA will continue to monitor and assess the COVID-19 pandemic impact on the covered entities and provide updates accordingly.
If a covered entity has specific questions regarding an audit once it has been engaged, please contact the Bizzell Group (the 340B audit contractor) at 340baudit@thebizzellgroup.com who will coordinate with HRSA based on the specifics of the request.