What Happens When the COVID-19 PHE Ends? Implications for Healthcare Providers

On January 30, 2023, the Biden Administration announced that the COVID-19 Public Health Emergency (“PHE”), which has been in effect since January 2020, is set to expire on May 11, 2023.

Considering the impending end to the PHE, healthcare providers will no longer have access to certain waivers that were made available to them during the PHE. Therefore, providers currently operating pursuant to COVID-19 related waivers are urged to review their current practices, policies, and procedures to ensure their operations remain compliant. For example:

• Physician practices operating in accordance with CMS waivers to the Stark physician self-referral prohibition should take action to assure that their physician compensation arrangements comport with an exception where necessary, including by exploring the new Value-Based Enterprise exception.
• Telehealth providers prescribing controlled substances should develop strategies to implement alternative patient treatment plans in preparation for the expiration of DEA’s flexibilities on telemedicine prescribing requirements.
• Telehealth providers rendering care to CMS beneficiaries must review which PHE accommodations will expire at the end of the PHE, which will extend for 151 days after the PHE, and which have been the subject of legislative action to offer greater extension, such as those in the Advancing Telehealth Beyond COVID-19 Act of 2022, which aims to extend certain Medicare flexibilities through 2024.
• Providers who are reducing or waiving patient cost-sharing obligations subject to OIG’s enforcement discretion must evaluate whether their activities can meet an applicable safe harbor to the Anti-Kickback Statute and, if not, cease engaging in this activity.
• Laboratory specimen collection reimbursement will change, and labs must be aware of how offsite collection activities may be billed and reimbursed.
• Providers should be aware that the end of the PHE will trigger states to begin rolling back licensing flexibilities that have not already expired.
• Upon the expiration of the PHE-related flexibility, providers engaged in “incident to” billing will no longer satisfy Medicare’s direct supervision requirement through virtual presence and will instead need to ensure the in-person (onsite) availability of a supervising physician.

The federal government previously committed to providing at least 60 days’ notice prior to the expiration of the PHE, and the statement issued earlier this week offers 101 days. Healthcare and life science stakeholders must take advantage of this additional advance notice to proactively review and adjust the practices they may have adopted during the PHE. Contact Frier Levitt for assistance assessing whether your organization’s activities comport with applicable federal and state laws in the absence of COVID-19 related waivers and to assure your compliance as you transition out of this period.