1. HRSA/OPA Guidance in Response to COVID-19

Late yesterday, HRSA/OPA updated its website to include guidance addressing the COVID-19 pandemic.  The guidance states:

  • Case-by-Case Waivers – OPA is reviewing on a case-by-case basis requests from covered entities related to compliance with 340B guidance while dealing with COVID-19.  Covered entities that want to request a waiver or seek guidance should contact Apexus at 1-888-340-2787 (Monday – Friday, 9 a.m. – 6 p.m. ET) or apexusanswers@340bpvp.com. It is our understanding that requests must be submitted by the Authorizing Official or Primary Contact.  In an FAQ, OPA states that requests for expansion of services to new sites, or accelerated registration of new sites, will also be evaluated on this case-by-case basis.
  • Relaxed Documentation Standards – OPA confirmed that its guidance related to relaxed documentation standards during a public health emergency (PHE) are in effect.  However, OPA stated that it cannot relax its definition of a 340B eligible patient during the PHE. The website states that it will allow covered entities to use abbreviated medical records to demonstrate a patient relationship with an individual, that it will allow covered entities to rely on a patient’s self-reporting of identity, condition and history if the patient is without insurance cards or other documentation.  Additionally, if a covered entity relies on volunteers as caregivers, the covered entity should keep documentation of the relationship between the covered entity and the volunteer and the emergency nature of the situation.  The covered entity is still required to keep auditable records and have policies and procedures that address proper dispensing of 340B drugs.
  • Telemedicine – With regard to telemedicine, OPA states 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.”   As a reminder, a prescription that is written as the result of a telehealth visit may be filled with 340B drugs, provided that the three prongs of the patient definition are met.
  • Audits – OPA is moving toward conducting audits virtually during the pandemic.  Covered entities that have specific questions about a current audit should contact 340baudit@thebizzellgroup.com.
  1. DEA Waiver on Prescriptions for Controlled Substances Issued Through Telehealth

The DEA announced a waiver that allows controlled substances to be prescribed through a telehealth visit rather than an in-person encounter.  In addition, the prescriber may issue a prescription either electronically (for schedules II-V), by calling in an emergency schedule II prescription to the pharmacy, or by calling in a schedule III-V prescription to the pharmacy.   The following requirements must be met:

  1. the prescription must be issued for a legitimate medical purpose by a practitioner acting in the usual course of his/her professional practice;
  2. the telemedicine communication must be conducted using an audio-visual, real-time, two-way interactive communication system; and
  3. the practitioner must be acting in accordance with applicable Federal and State laws.

While the DEA announced this waiver of federal restrictions, states may still have laws that impose similar restrictions on a practitioner’s authority to prescribe controlled substances via telehealth.