HRSA’s Office of Pharmacy Affairs (OPA) has posted guidance for 340B covered entities during the COVID-19 pandemic. The guidance can be accessed on the HRSA OPA website at https://www.hrsa.gov/opa/COVID-19-resources.
Some of the questions addressed in the guidance include:
Patient eligibility – Although HRSA has not waived the patient eligibility standards, it notes that an “abbreviated patient record” may be adequate provided that the record is auditable. According to HRSA, the record should identify the patient, record the medical evaluation (including any testing, diagnosis, or clinical impressions) and the treatment provided or prescribed. However, the record can be in a single form or note page. Moreover, HRSA notes that providers may not have access to medical histories so self-reporting of identity, condition, and medical history will be adequate for purposes of 340B recordkeeping
Telehealth – HRSA considers telehealth to be “merely a mode” for the delivery of health care services that can be utilized consistent with any other applicable requirements. Accordingly, HRSA recommends that covered entities outline the use of telehealth in their polices and procedures and continue to assure that there is an auditable record of a telehealth encounter for patients dispensed a 340B drug.
Site registration – Covered entities that have a specific question about the site eligibility of a new site are directed to contact the 340B Prime Vendor Program(1-888-340-2787 or firstname.lastname@example.org and HRSA will evaluate each circumstance on a case-by-case basis.
Audits – HRSA expects to conduct 340B Program covered entity audits remotely (virtually) for the next several months. Covered entities are directed to contact the 340B audit contractor, the Bizzell Group at email@example.com, if they have specific questions regarding an audit once it has been engaged.
Covered entities are reminded that the quarterly registration period for new sites and contract pharmacies is now open continuing until April 15, 2020.
HRSA is likely to update the 340B guidance as needed during the pandemic. Covered entities should monitor the HRSA/OPA website regularly for up-to-date information.
For more information about the 340B Program, please contact Feldesman Tucker attorneys Michael B. Glomb (MGlomb@ftlf.com), Jason B. Reddish (JReddish@ftlf.com), or Noori Ali (NAli@ftlf.com).