The U.S. Department of Health and Human Services (HHS) has announced the coming end of the COVID-19 Public Health Emergency (PHE) and has provided guidance on the phase-out of PHE 1135 Waivers. HHS announced that the PHE will expire on May 11, 2023, which will trigger the planned transition and phase-out of PHE 1135 Waivers.
During the COVID-19 PHE, HHS and its constituent agencies, such as the Centers for Medicare & Medicaid Services (CMS), waived many regulatory requirements to create additional flexibility for providers to help ensure that beneficiaries’ needs for healthcare items and services continued to be met during the pandemic. Under the 1135 Waivers, a provider’s noncompliance with certain requirements would generally not result in sanctions so long as the goods or services were provided in good faith and absent of fraud and abuse. As the pandemic winds down and the PHE ends, HHS has provided guidance on the phasing out of the 1135 Waivers and has provided insight on which items and services will and will not be affected moving forward.
According to HHS, the federal government will stop providing free COVID-19 vaccines and treatments, primarily because Congress has not authorized additional funds to purchase more vaccines and treatments. Instead, these items will be transitioned to traditional health insurance carriers. HHS has indicated that this transition will be accomplished in a “thoughtful, well-coordinated manner” and that carriers would cover COVID-19 vaccines and treatments without co-pays, but HHS has not released details or addressed how this transition will impact providers. COVID-19 testing will similarly be affected. While Congress required insurance carriers to cover certain COVID-19 tests during the PHE, when the PHE ends, this requirement will also end and coverage for COVID-19 testing will be determined solely by the individual carrier’s coverage policies.
Medicare and Medicaid telehealth flexibilities will also not be immediately affected. HHS announced that the vast majority of current Medicare telehealth flexibilities will remain in place through December 2024, and the state-specific Medicaid telehealth flexibilities that were in place before the COVID-19 PHE will continue to be available after the PHE ends. Similarly, the end of the PHE will not impact the FDA’s authority to issue Emergency Use Authorizations (EUAs), and current EUAs will remain in effect, although without the urgency of an ongoing pandemic, the FDA may be more conservative in issuing EUAs.
Patients in Opioid Treatment Programs will continue to be able to start buprenorphine via telehealth without the required initial in-person examination, and the flexibilities that allowed an increased number of take-home doses of methadone for opioid use disorder treatment will be extended to May 11, 2024. Although HHS also announced that the Drug Enforcement Administration (DEA) has plans to implement rules that will impact this flexibility. HHS also announced that flexibilities that allowed for expanding facility capacity during the PHE will come to an end.
For over 35 years, Wachler & Associates has represented healthcare providers and suppliers nationwide in a variety of health law matters, and our attorneys can assist providers and suppliers in understanding changes in laws and regulations affected by the COVID-19 pandemic. If you or your healthcare entity has any questions pertaining to HIPAA compliance or healthcare compliance, please contact an experienced healthcare attorney at 248-544-0888 or wapc@wachler.com.