In response to the unprecedented nature of COVID-19, the federal government declared numerous types of emergencies, Congress enacted several pieces of legislation, and various executive actions were taken and waivers issued, which, collectively, established time-limited flexibilities and provisions designed to protect individuals and the health system during the pandemic. The effective end dates of many, though not all, of these flexibilities and provisions are tied to the public health emergency (PHE) declaration made pursuant to Section 319 of the Public Health Service Act, first declared in January of 2020.  Others are linked to the public health emergency declaration made under Section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act; the declaration made under the Public Readiness and Emergency Preparedness (PREP) Act; and emergency and major disaster declarations made under the Stafford Act. In some cases, subsequent legislation has either delinked provisions from these declarations or otherwise changed their duration.

The Biden Administration recently announced that it will end the PHE on May 11, 2023 and FEMA has announced that the emergency incident period under the Stafford Act will also end on that date. Other related emergency declarations or provisions have already ended or are ending soon. The following table (Table 1) provides a timeline identifying key health-related flexibilities and provisions specified by these various measures, the specific measure that determines their end date, and their end date (an end date for the Section 564 declaration has not yet been announced).

In addition to the end of the flexibilities detailed in Table 1 below, there are also expectations that the federal supply of COVID-19 vaccines could be depleted or need to be replaced by an updated booster dose sometime this year and, similarly, the federal supply of COVID-19 treatments will also be depleted. At a result, COVID-19 vaccines and treatments are transitioning to the commercial market. Importantly, this change is not tied to the end of the public health emergency.

Click here to see the list of deadlines in the referenced table.

The Biden administration has announced the launch of a $1.1 billion public-private partnership called “Bridge Access Program” aimed at giving uninsured individuals access to COVID-19 vaccines and treatments by the U.S. Department of Health and Human Services (HHS). At the end of the Public Health Emergency, the financial obligation of paying for these vaccines and treatments shifts to the private sector. Most people should continue to pay nothing out-of-pocket for vaccines but out-of-pocket expenses for treatments such as Paxlovid may change. The program has two components which include ensuring safety net programs like Community Health Centers will receive vaccines purchased at a discounted rate from the CDC and HHS will contract with pharmacies that will allow them to continue to provide COVID-19 treatments like Paxlovid free of charge to the uninsured.

The Department of Health and Human Services is planning for the federal Public Health Emergency for COVID-19 (PHE), declared under Section 319 of the Public Health Service Act, to expire at the end of the day on May 11, 2023. Today, the Centers for Medicare & Medicaid Services (CMS) issued FAQs on CMS Waivers, Flexibilities, and the End of the COVID-19 PHE. The FAQs will help you prepare for the expiration of the COVID-19 PHE and are relevant for all CMS programs; including, Medicare, Medicaid, the Children’s Health Insurance Program (CHIP), and private insurance.

CMS resources for the expiration of the COVID-19 PHE:

• Fact Sheet: What Do I Need to Know? CMS Waivers, Flexibilities, and the Transition Forward from the COVID-19 Public Health Emergency
• FAQs on CMS Waivers, Flexibilities, and the End of the COVID-19 PHE
• CMS Current Emergencies Web Page

 From the RUPRI Center for Rural Health Policy Analysis: In December 2022, the proportion of the population ages 12+ with a completed primary COVID-19 vaccination (i.e., have a second dose of a two-dose vaccine or one dose of a single-dose vaccine) was 75.5 percent in metropolitan counties, 60.9 percent in micropolitan counties, and 56.8 percent in noncore counties.

 The latest feature article in The Rural Monitor shares what’s known about the post-COVID illness that’s estimated to affect as many as 3 million in rural areas.  As of December 2022, data from the Centers for Disease Control and Prevention show that the top five states for self-reported symptoms are mostly rural: Montana, Wyoming, Mississippi, Kentucky, and Alaska.

  The National Association of Rural Health Clinics first describes some of the COVID-related waivers and flexibilities that applied widely – such as those reducing barriers to telehealth – and then those that were specific to RHCs.  These include relaxed requirements that physicians provide medical direction to nurse practitioners and justification to provide home nursing services, among others.  These waivers will end with the public health emergency.

Moderna bivalent COVID-19 vaccine for children under six is available for ordering through the Health Center COVID-19 Vaccine Program. However, due to limited availability nationwide, Pfizer-BioNTech bivalent COVID-19 vaccine for children under five is not available for ordering. A new supply of Novavax is now available to order, with a cap of 100 doses per site and an expiration date of April 30. A few important reminders:

• The monovalent formulation of COVID-19 vaccine products is authorized for the primary series only. Please order only what you anticipate using over the next 7-10 days and track your supplies to assess the need and adjust current ordering patterns to avoid stockpiling.
• Moderna has recently expanded expiration dates for the monovalent vaccine for children under six. Always check the Pfizer BioNTech and Moderna expiry dates for the products in your inventory before wasting them.
• The Emergency Use Authorization (EUA)-labeled Pfizer adult (12+) monovalent vaccine is no longer available to order. Health centers requiring the Pfizer adult (12+) monovalent vaccine should order the Biologics License Application (BLA)-labeled (COMIRNATY) product (NDC 00069-2025-10).
• Centers for Disease Control and Prevention (CDC) released a fact sheet for single-dose vials of the updated Pfizer BioNTech COVID-19 vaccines for people 12 years and older.
• ASPR updated the Federal Response to COVID-19: Therapeutics Clinical Implementation Guide, a comprehensive review of available COVID-19 therapeutic treatment options and key prescribing, implementing, and administering information.

Earlier this week, the Centers for Medicare & Medicaid Services released a fact sheet with updates to policy on vaccines, testing, and treatments; telehealth services; continuing flexibilities for healthcare professionals; and expanded hospital capacity through care in a patient’s home.  Last week, the agency provided updates specific to Rural Health Clinics and Critical Access Hospitals, describing the Medicare and Medicaid waivers and flexibilities that have been terminated, made permanent, or that will end with the public health emergency (PHE) on May 11, 2023.

As part of the Centers for Medicare & Medicaid Services’ (CMS) ongoing efforts to provide up-to-date information to prepare for the end of the Public Health Emergency (PHE) for COVID-19, which is expected on May, 11, 2023, we are providing a new overview fact sheet on CMS Waivers, Flexibilities, and the Transition Forward from the COVID-19 Public Health Emergency.  COVID-19 efforts have been a significant priority for the Biden-Harris Administration, and with the use of whole-of-government approach, the country is in a better place. Over the next several months, CMS will work to ensure a smooth transition back to normal operations.

The CMS Waivers, Flexibilities, and the Transition Forward from the COVID-19 Public Health Emergency provides clarity on several topics including:

• COVID-19 vaccines, testing, and treatments;
• Telehealth services;
• Health Care Access

In the coming weeks, CMS will be hosting stakeholder calls and office hours to provide additional information. Please visit the CMS Emergencies Page for continuous updates regarding PHE sunsetting guidance as information becomes available to the public.