Based on the current COVID-19 trends, the Department of Health and Human Services is planning for the federal public health emergency for COVID-19 to expire on May 11, 2023. Under Section 319 of the Public Health Service Act, the coronavirus was first declared as a public health emergency on January 31, 2020, and a national emergency that March. The end of the public health emergency will mean changes in the practices that many businesses have adopted over the last three years. The pharmacy industry is no exception. As the public health emergency winds down, pharmacy benefit managers (PBMs) have begun to notify pharmacies that waivers provided during the emergency?specifically waivers related to mailing and patient signatures?will no longer be valid.
During the public health emergency, many PBMs waived certain requirements for patient signatures upon receipt of prescriptions—whether through pickup at the pharmacy or delivery to patient residences. With strict lockdowns and social distancing guidelines, many patients, especially those with chronic illnesses, were unable to physically sign for their receipt of medications. PBMs, in response, waived the signature requirement and instead allowed delivery or pickup logs to include a brief statement reading "impacted by COVID-19" to satisfy signature requirements. Another alternative PBMs allowed was proof of trackable delivery information to the patient's residence. These waivers further condoned retail pharmacies servicing patient via the mail and third-party couriers, and PBMs did not require in-person deliveries or delivery drivers to hand deliver prescriptions as they had previously.
With the end of the public health emergency imminent, the major PBMs have begun to alert the pharmacies in their network that these waivers are set to expire. The Pharmacy Audit Assistance Service National LLC has released a list of PBMs and payers who have reinstated pre-COVID-19 signature requirements and when these policies took effect. Certain PBMs have recently announced that, in the next few weeks, they will require that network pharmacies obtain patient signatures as proof of delivery and dispensing?and that without such signatures, those claims will be subject to recoupment in future audits. Claims dispensed without a signature on or after the date of this policy change will be subject to audit recoupment. And another major PBM recently announced a similar rollback of COVID-19-era waivers requiring network pharmacies to revert back to in-person pickups or hand delivery of medications (as opposed to mailing medications or delivering them through at third-party courier).
Pharmacies can expect other PBMs to follow suit. Pharmacies should plan to reinstate the signature requirement for prescription medication. Further, pharmacies should ensure that patients are no longer treated via mail, unless a separate waiver or contract exists outside of the COVID-19 waivers allowed by PBMs. As always, pharmacies are encouraged to review their PBM's provider manuals and monitor their communications for updates.
Duane Morris attorneys will continue to monitor developments in this area and other related issues and report on the key details for the industry in subsequent Alerts.
For More Information
If you have any questions about this Alert, please contact Jonathan L. Swichar, Bradley A. Wasser, Jessica Linse, any of the attorneys in our Pharmacy Litigation Group or the attorney in the firm with whom you are regularly in contact.
Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.
