340B Compliance During Declared COVID-19 Public Health Emergency

Effective Date: [DATE]

  1. Purpose

    The purpose of this policy is to establish policies and procedures to ensure [Covered Entity] maintains compliance with 340B program requirements during the period of the declared COVID-19 Public Health Emergency.

  2. Policy and Updates

    Under the 340B Program, manufacturers are required to offer discounts on covered outpatient drugs to eligible 340B covered entities as a condition of those drugs being covered under Medicaid and Medicare Part B. Recipients or sub-recipients of the Ryan White CARE Act are eligible covered entities. The 340B Program is administered by the Office of Pharmacy Affairs (OPA), which is a division of the Health Resources and Services Administration (HRSA) within the Department of Health and Human Services (HHS). Upon registration as a participant in the 340B Program, covered entities agree to abide by statutory requirements and prohibitions, as well as HRSA guidance, and may be audited by HRSA to ensure compliance.

    During a period of a Public Health Emergency (PHE) declared by the Secretary of HHS, HRSA may permit 340B covered entities to adopt and follow more flexible 340B compliance policies and procedures. HRSA has announced some flexibilities to address the COVID-19 pandemic, which are published on its COVID-19 Resources page (see https://www.hrsa.gov/OPA/COVID- 19-resources).

    [Covered Entity] will monitor the time period for which HRSA permits these flexibilities and at the time HRSA announces that the flexibilities are no longer in effect, [Covered Entity] will revert to its policies and procedures applicable before the declared COVID-19 PHE. During the COVID-19 PHE, [Covered Entity] will revise these policies and procedures as needed in response to any changes in guidance issued by HRSA on the COVID-19 Resource page. [Covered Entity] will maintain records of the date of adoption of the revised COVID-19 PHE policies and procedures.

  3. Procedures

    1. 340B Patient Definition

      During the COVID-19 PHE, [Covered Entity] will continue to prescribe, dispense, or administer 340B drugs only if the relationship between the [Covered Entity] and the individual receiving the 340B drug meets the following criteria:

      1. [Covered Entity] maintains records of the individual’s health care that resulted in the prescription;

      2. The individual has received a health care service from a health care provider employed by or under contractual or other arrangements with [Covered Entity] such that [Covered Entity] retains responsibility for the care provided; and

      3. The individual has received a service consistent with the service or range of services for which grant [and/or sub-grant] funding has been provided.

        If a prescription is written as the result of a referral of a [Covered Entity] patient to a provider that is not affiliated with [Covered Entity], [Covered Entity] will qualify the prescription written by the unaffiliated provider only if the [Covered Entity’s] medical records document the referral and include a summary of the healthcare visit during which the prescription was written or a copy of the medical record from that visit.

        HRSA has announced that covered entities have flexibility with respect to the documentation required to demonstrate a patient relationship during the COVID-19 PHE. [Covered Entity] will maintain documentation under these relaxed standards on an as-needed bases. During the COVID-19 PHE, it may not be feasible for [Covered Entity] to maintain typical health record documentation. In these cases, an abbreviated health record may be adequate. The abbreviated health record will identify the patient, record the medical evaluation (including any testing, diagnosis, or clinical impressions), and the treatment provided or prescribed. The record may be a single form or note page. If an individual presents without insurance cards or identity papers and [Covered Entity] does not have access to documented medical histories, the individual’s self-reporting of identity, condition, and history will be adequate for purposes of [Covered Entity’s] 340B recordkeeping requirements.

        If volunteer health professionals are providing health care on behalf of [Covered Entity], [Covered Entity] will generate emergency documentation to demonstrate the relationship between the professional and [Covered Entity] and that [Covered Entity] is responsible for the care provided. The documentation will be kept on file by [Covered Entity] and include:

        1. A description of the emergency nature of the situation;

        2. The name and address of the volunteer; and

        3. The volunteer’s relationship to [Covered Entity].

    2. Eligible Location

      If additional space is required for [Covered Entity] to expand the delivery of patient care during the COVID-19 PHE, the [Covered Entity] may expand into additional space in the following circumstances:

      1. Expanded care delivery location will be considered 340B eligible if the care is provided at the same physical address as [Covered Entity] and represents an expansion of

        services that are consistent with the service or range of services for which grant [and/or sub-grant] funding has been provided.

      2. [Covered Entity] may submit a request to HRSA to immediately enroll a new location in the 340B program. The new location will be considered 340B eligible upon HRSA’s approval. The request will be submitted by contacting: 1-888-340-2787 or apexusanswers@340bpvp.com. [Covered Entity] will be prepared to provide the following information: 1) a statement that the need for immediate registration of the facility is related to the [Covered Entity’s] COVID-19 response; 2) acknowledgment of the urgency for an immediate registration of the facility; and 3) details about how the facility is responding to COVID-19.

    3. Telehealth

      HRSA has acknowledged on its COVID-19 Resource page 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.” During the COVID-19 PHE, [Covered Entity] may provide health care services to eligible patients via telehealth. When prescriptions are written as a result of a telehealth visit, [Covered Entity] will ensure that all elements of the 340B patient definition are met (see Section III(a)). The telehealth visit will be recorded in the Covered Entity’s medical records like any other outpatient visit. In order to prevent the spread of COVID-19, both the prescriber and the patient may be located outside of the [Covered Entity] facility while the telehealth services are being provided. The fact that the prescriber and/or the patient are not located at the [Covered Entity] facility during the telehealth visit will not be a reason to disqualify the prescription for 340B.

    4. HRSA Guidance During Public Health Emergencies

      HRSA may issue additional guidance during the COVID-19 PHE that may affect [Covered Entity’s] 340B operations, as well as ease the burden of record keeping or reporting requirements. This additional guidance will be noted and recorded by [Covered Entity’s] 340B Compliance team, incorporated into these Policies and Procedures as needed, and communicated to [all locations (if applicable) and] all staff involved in 340B Program compliance.

      To the extent that there is a specific circumstance for which [Covered Entity] believes its COVID- 19 PHE response may affect compliance or eligibility in the 340B Program, a member of [Covered Entity’s] 340B Compliance Team will contact the 340B Prime Vendor immediately.

    5. Auditable Records

[Covered Entity] will continue to maintain auditable records during the COVID-19 PHE, including records related to the prohibitions on diversion and duplicate discounts.