HRSA Unveils New 340B Flexibilities During COVID-19 Crisis

As the COVID-19 crisis continues to unfold, the Health Resources & Services Administration Office of Pharmacy Affairs (HRSA OPA) has taken unprecedented steps to provide 340B Program participants with additional flexibility to help meet surging patient demand. At the highest level, HRSA OPA acknowledges that "this public health emergency may warrant additional flexibilities, especially to affected 340B covered entities."

More specifically, HRSA OPA has taken the following steps and provided the following guidance to assist 340B Program participants treating a surge in patients during this crisis:

• Relaxing patient recordkeeping requirements necessary to determine patient eligibility. HRSA OPA has stated that for the time being "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."
• Confirming that volunteer health professionals providing health care on behalf of the covered entity may be considered eligible providers for purposes of the 340B Program. 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.
• Indicating that "case-by-case" exceptions may be granted for covered entities seeking to expand their services to new sites outside of the normal enrollment process.
• Confirming that as of now, HRSA OPA is unable to waive the 340B statutory requirements related to the eligible patient definition and GPO prohibition.
• Clarifying that telehealth encounters remain eligible for 340B Program purposes. HRSA OPA 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.
• Moving toward conducting 340B Program covered entity audits remotely (virtually) for the next several months while HRSA OPA monitors and assesses the impact on the covered entities.

HRSA OPA's unprecedented actions will likely be quickly evolving and subject to change. 340B Program participants should carefully evaluate how these new flexibilities may enable them to expand existing services to rise to the unique challenge of this crisis.

If you have any questions about these updates and how they might affect your 340B Program participation, please contact your Quarles & Brady attorney or:

• Brenda M. Maloney Shafer: (602) 229-5774 / brenda.shafer@quarles.com
• Richard B. Davis: (414) 277-5844 / richard.davis@quarles.com