This week’s summary of COVID-19 impact on 340B

March 27, 2020

With so many headlines vying for your attention, we wanted to provide a recap of the top developments affecting your 340B program. Here is a roundup of eight key points impacting 340B compliance during this designated public health emergency:

  1. 340B policies and procedures must include telehealth and non-traditional health care delivery if utilized at your facility. 
    “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,” HRSA says. If you have implemented telehealth or other online health care delivery models, make sure they are reflected in your 340B policies and procedures. You must also maintain auditable records for all eligible patients dispensed a 340B drug.
  2. Registration periods will continue as scheduled. 
    For the eligibility of a new 340B parent site, child site, or contract pharmacy, registrations will continue to be accepted only during the first two weeks of each quarter. If you have a concern or would like to be considered for an exception, contact the Prime Vendor Program (PVP) at 1-888-340-2787 or [email protected].
  3. Patient definition remains the same during this time, regardless of treatment for COVID-19
    “At this time, HRSA is unable to waive 340B statutory requirements, specifically the provision related to reselling or otherwise transfering 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.,” HRSA says. However, as the situation progresses, it is important to reference the HRSA website to follow any new developments.
  4. Hospitals subject to the Group Purchasing Organization (GPO) prohibition will be allowed to purchase outpatient drugs from a GPO ONLY IF drug shortages prevent the covered entity from purchasing the covered outpatient drug at 340B ceiling price OR wholesale acquisition cost (WAC). 
    Hospitals that are subject to the GPO prohibition include disproportionate share hospitals, children’s hospitals, and freestanding cancer hospitals. If you are subject to the GPO prohibition and foresee this as a possibility, it is essential to address these situations in your policies and procedures while also maintaining auditable records. To learn more, read this statement released by 340B Health.
  5. HRSA audits will be conducted remotely (virtually) for the next several months. 
    If you have a specific question regarding an audit that is underway, please contact the Bizzell Group (the 340B audit contractor) at [email protected].
  6. 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.
  7. Proper documentation is needed for volunteer health professionals. 
    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 his/her relationship to the clinic, and should be kept on file by the covered entity.
  8. CMS has not been authorized to begin surveying 340B hospitals about their Medicare Part B drug acquisition cost.
    CMS scheduled the survey to run from March 23 through April 10, but as of March 21, had not received authorization from the White House Office of Management and Budget to proceed.

As the pandemic continues, the 340B program may be impacted in additional ways. The guidance and resources provided here were current on March 27, 2020. Please visit the HRSA COVID-19 resources page for the latest.