This article was first published on February 8, 2023. It was most recently updated on May 9, 2023. The most recently updated content is denoted by italics.
The Biden administration has announced plans to end the COVID-19 national and public health emergencies on May 11, 2023. The emergency declarations, which grant the government the ability to waive and modify laws in order to address the emergency, were first declared by President Trump on March 13, 2020. The plans to end the PHE align with the administration’s previous commitment to providing at least 60 days’ notice before terminating it.
A lot has changed since the initial declaration, and the end of the emergencies will have an impact on many, not least healthcare providers, who must now shift their preparations to life after the PHE. But what will change at the end of the public health emergency, and which measures will remain in place?
What Will Be Affected?
Charges for COVID-19 Tests, Vaccines, and Treatment
Empowered by the PHE, the government has been able to provide many Americans with COVID-19 tests, treatments, and vaccines at no charge. After May 11, the parameters will change1.
- Medicare beneficiaries will, generally, face out-of-pocket costs for at-home testing and all treatment. However, the cost of vaccines will still be covered, as will testing ordered by a healthcare provider.
- Those on state Medicaid programs will still have costs covered for tests ordered by a physician and vaccines, as well as COVID-19 treatments, through September 30, 2024. However, coverage and cost sharing may vary by state after that2.
- Those with private insurance may face charges for lab tests, even if they are ordered by a provider. Although vaccinations will continue to be free with in-network providers, going to an out-of-network provider could incur charges.
The U.S. Government may also continue to distribute free COVID-19 tests from the Strategic National Stockpile, per HHS, dependent on supply and resources. Similarly, pending resource availability, the Increasing Community Access to Testing (ICATT) program led by the Centers for Disease Control and Prevention (CDC) may also continue2.
Certain Public Readiness and Emergency Preparedness (PREP) Act Liability Protections
Following the end of the PHE, tests, treatments, and vaccines will transition from U.S. government agreement to traditional pathways of procurement, distribution, and payment. Under planned amendments to the PREP Act, some liability coverage will be impacted.
At the end of the PHE on May 11, coverage will no longer extend to all routine childhood vaccinations by pharmacists, pharmacy interns, and pharmacy technicians.
Once products are no longer distributed under a U.S. government agreement, PREP Act coverage will no longer extend to:
- COVID-19 vaccination by non-traditional providers (e.g. recently retired providers and students).
- COVID-19 vaccinations across state lines by licensed providers and pharmacists and pharmacy interns.
More details on the Amendment to the Declaration Under the PREP Act for Medical Countermeasures Against COVID-19 can be found in this HHS Fact Sheet.
Certain Medicare and Medicaid Waivers and Broad Flexibilities for Healthcare Providers
During the PHE, CMS has issued various emergency authority waivers, regulations, and sub-regulatory guidance to ensure and expand access to care. Many states, hospitals, nursing homes, and other providers are still operating under hundreds of these waivers, which affect care delivery and payment and are integrated into patient care and provider systems. At the conclusion of the PHE, these special measures will end2.
For Medicaid measures, it’s a bit more complicated. While some PHE waivers and flexibilities will end on May 11. others will remain in place for six months following the end of the PHE. In addition, many of the measures, including those that support home- and community-based services, will be available to states beyond the PHE at their discretion. Examples of how states have used these flexibilities include “to increase the number of individuals served under a waiver and expand provider qualifications,” per United States Department of Health and Human Services (HHS).
Enforcement Discretion for Telehealth Remote Communications
Early in the pandemic, the Office for Civil Rights (OCR) announced it would not impose penalties for noncompliance with regulatory requirements under the HIPAA Rules against covered healthcare providers in connection with the good faith provision of telehealth during the PHE.
Among other protections, this amendment meant providers did not have to be licensed in the state where the patient was located and were permitted to treat patients in other states. It also enabled providers to use non-HIPAA-compliant platforms as long as they were not public facing.
This protection will come to an end on May 11. OCR, however, is providing a 90-day transition period for healthcare providers to come into compliance with HIPAA rules regarding telehealth.
Penalties for Some HIPAA Violations
During the height of the pandemic, healthcare providers utilized alternative methods to contact patients. To protect them, the HHS waived potential penalties for HIPAA violations that occurred while serving patients in good faith through everyday communication technologies, such as widely accessible services like FaceTime or Skype, for telemedicine purposes, even if the service is not related to COVID-193. At the conclusion of the PHE, these penalties will no longer be waived.
Workforce Permissions
CMS has permitted greater staffing flexibility during the PHE. This has allowed nurse anesthetists to work without physician supervision and nurse practitioners to do so in some settings. Non-physician practitioners have also been allowed to supervise diagnostic tests. In addition, CMS permitted physicians whose privileges at hospitals or ambulatory surgery centers expired, or new physicians who hadn’t gained full approval yet, to continue practicing in order to assist with COVID-19-related workforce shortages4. It is expected that these staffing flexibilities will not be extended beyond the PHE.
Requirement for Manufacturers to Notify FDA of Disruptions
To detect early shortages of critical devices during the PHE, the FDA required manufacturers to notify them if they were no longer manufacturing a device or if manufacturing had experienced an interruption likely to impact the supply of that device in the United States. While this will end with the PHE, the FDA is seeking congressional authorization to extend this requirement beyond May 112.
Medicaid Redeterminations and Disenrollments Have Returned
In exchange for additional federal matching funds, states were barred from disenrolling people from Medicaid during the PHE. As a result, Medicaid enrollment skyrocketed to a record 90 million people. However, as of April 1, states were once again able to begin processing redeterminations and disenrolling residents who no longer qualified. In the coming months, millions are expected to lose their coverage.
It’s important to note that the decision to allow Medicaid disenrollment was separated from the PHE in December as part of Congress’ fiscal year 2023 government funding package.
What Will Not Be Affected
Many Telehealth Changes
Telehealth was one area of healthcare that evolved dramatically following the declaration of the public health emergency. A variety of changes to Medicare coverage were instituted, including provisions that allowed:
- Medicare beneficiaries in any geographic area to receive telehealth services, rather than only beneficiaries living in rural areas.
- Beneficiaries to remain in their homes for telehealth visits reimbursed by Medicare, rather than needing to travel to a healthcare facility.
- Telehealth visits to be delivered via smartphone in lieu of equipment with both audio and video capability.
- An expanded list of Medicare-covered services to be provided via telehealth3.
In addition, federally qualified health centers (FQHCs) and rural health clinics were permitted to provide telehealth services to Medicare beneficiaries in any location, rather than only being permitted when they were an originating site provider for telehealth3.
These flexibilities were originally due to expire 151 days after the termination of the public health emergency. However, the Consolidated Appropriations Act, 2023, which was approved in December 2022, extended the measures through December 31, 2024, regardless of the status of the PHE.
Emergency Use Authorizations
Although many emergency use authorizations (EUAs) have been issued during the COVID-19 public health emergency, they are not intrinsically linked. Upon news of the PHE’s upcoming termination, the FDA5 moved to confirm that EUAs are not impacted by the PHE. Key points provided by the FDA include:
- Public health emergencies exist under section 319 of the Public Health Service (PHS) Act, while EUA declarations are enabled by section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act.
- EUAs may remain in effect beyond the duration of a PHE if all other statutory conditions are met.
- If an EUA is to be terminated, notice of termination will be published in the Federal Register and, prior to that, the HHS Secretary will issue a Federal Register notice providing advanced notice to the public that the EUA declaration is being terminated.
Controlled Substance Prescription
To ease access to controlled substances, especially for patients in rural areas, the Drug Enforcement Administration (DEA) allowed its registered providers to prescribe them via telehealth during the PHE without first having evaluated the patient in person. After receiving a record 38,000 comments on the telemedicine rules it proposed in February, the DEA filed a rule on May 9 titled “Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications", which will ensure the PHE-era rules to stay in place until November 11.
The rule also dictates that any existing provider-patient telehealth relationship established before November 11, 2023, can continue through November 2024. Though the timeline for a final decision on the future of the policy remains unclear, a senior DEA official has said the agency is working to have clear regulations in place for patients before the extension expires.
Liability immunity for Prescribing and Dispensing COVID-19 Treatments
At the end of the PHE, pharmacists, pharmacy technicians, and pharmacy interns dispensing COVID-19 treatments in accordance with an FDA authorization will continue to receive liability immunity through the PREP Act. This includes the prescribing and dispensing of oral antiviral treatments Paxlovid and Lagevrio. In the case of Paxlovid, pharmacists are permitted to prescribe the treatment under certain circumstances.
Liability Immunity for Administering COVID-19 Tests and Both Flu and COVID-19 Vaccines
Pharmacists, pharmacy interns, and pharmacy technicians that administer COVID-19 and seasonal influenza vaccines (to those individuals three and over, consistent with other requirements), and COVID-19 tests, regardless of any USG agreement or emergency declaration, will continue to receive liability immunity from the PREP Act through December 2024.
Liability Immunity for COVID-19 Countermeasures Covered by Federal Agreements
Those involved in the provision of COVID-19 countermeasures that are provided based on a federal agreement (including the vaccines and treatments purchased and provided by the USG) or directly conducted by the USG — including by Federal employees, contractors, or volunteers — will continue to receive liability immunity under the PREP Act until December 2024.
The “Test to Treat” Program
With the goal of helping people quickly access lifesaving treatments for COVID-19 at little to no cost, the Biden administration launched the “Test to Treat” program. Despite the end of the PHE, pharmacists and other providers prescribing tests under the “Test to Treat” program will continue to receive liability protection under the PREP Act.
Access to Buprenorphine for Opioid Use Disorder Treatment in Opioid Treatment Programs (OTP)
From early in the pandemic, the Substance Abuse and Mental Health Services Administration (SAMHSA) permitted patients to start buprenorphine in an OTP by telehealth without first taking the required in-person exam. SAMHSA has proposed to make this permanent as part of changes to OTP regulations in a Notice of Proposed Rulemaking that it released in December 2022. SAMHSA has committed to providing an interim solution if the proposed OTP regulations are not finalized prior to May 112.
Access to Expanded Methadone Take-Home Doses for Opioid Use Disorder Treatment
SAMSHA also allowed an increased number of take-home doses to patients taking methadone in an OTP. After research and feedback showed this to be a positive change, SAMSHA announced it would extend the flexibility for one year from the end of the PHE until May 11, 2024, with the view of making it a permanent change before then2.
Sources
1 https://www.cnn.com/2023/01/30/politics/may-11-end-of-covid-and-public-health-emergencies/index.html
