With more than two years having passed since the COVID-19 pandemic began in early 2020, questions are being raised about when to end the public health emergency declarations made by the federal government early on, with some advocating for their extension and others calling for their expiration. There are numerous implications to ending these emergency declarations, each of which gave the federal government flexibilities to waive or modify certain requirements in a range of areas, including in the Medicare, Medicaid, and CHIP programs, and in private health insurance, as well as to allow for the authorization of medical countermeasures and to provide liability immunity to providers who administer services, among other things. In addition, Congress also enacted legislation that provided additional flexibilities tied to one or more of these emergency declarations, and as such they too are scheduled to expire when (or at a specified time after) the emergency period(s) expires.
This brief provides an overview of the major health-related COVID-19 federal emergency declarations that have been made, summarizes the flexibilities triggered by each, and identifies the implications for their ending, in the following areas:
This is not meant to be an exhaustive list of all federal policy and regulatory provisions made in response to COVID-19 emergency declarations. For example, we do not cover the entire range of federal and state emergency authorities exercised under Medicaid Disaster Relief State Plan Amendments (SPAs), other Medicaid and CHIP SPAs, and other state-reported administrative actions; Section 1115 waivers; Section 1135 waivers; and 1915 (c) waiver Appendix K strategies. The Centers for Medicare & Medicaid Services maintains a more complete list of coronavirus waivers and flexibilities that have been exercised since early 2020; some state actions to respond to the emergency may have expiration dates that are not tied to the end of the federal emergency declarations.
Overview of Major Health-Related COVID-19 Federal Emergency Declarations
The early days of the COVID-19 pandemic were marked by several emergency declarations made by the federal government, under several broad authorities, each of which has different requirements related to expiration.
- A public health emergency (PHE) was initially declared by the Secretary of the Department of Health and Human Services (HHS) in late January 2020, pursuant to Section 319 of the Public Health Service Act. A PHE lasts for 90 days and must be renewed to continue; the PHE for COVID-19 has been renewed several times, most recently in April 2022, and is currently scheduled to expire in mid-July 2022. The Biden Administration has said that it will give states a 60 day notice before the PHE expires.
- A national emergency declaration was issued by former President Donald Trump in March of 2020, pursuant to Section 201 of the National Emergencies Act. A national emergency declaration is in effect unless terminated by the President, or through a joint resolution of Congress, or if the President does not issue a continuation notice annually. Such a notice was issued by President Trump to continue the emergency beyond March 1, 2021 and by President Biden to continue beyond March 1, 2022.
- A separate emergency declaration pursuant to Section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act was issued by the Secretary of HHS in February 2020. Based on this determination, on March 27, 2020, the Secretary declared that circumstances existed to justify emergency use authorization (EUA) of medical countermeasures for COVID-19. An EUA is a mechanism to facilitate availability and use of medical countermeasures that are determined to be safe and effective but have not yet been formally approved. An emergency declaration issued pursuant to Section 564 of the FD&C Act remains in effect until terminated by the HHS Secretary.
- A declaration under the Public Readiness and Emergency Preparedness (PREP) Act (pursuant to Section 319F-3 of the Public Health Service Act) was issued by the Secretary of HHS in March 2020. This declaration provides liability immunity for activities related to COVID-19 medical countermeasures. Since then, 10 amendments to the declaration have been issued to extend liabilities related to COVID-19 countermeasures. For a PREP Act emergency determination, the Secretary must specify an end date; in this case, it has been set as October 1, 2024.
Key Flexibilities Triggered by Major COVID-19 Federal Emergency Declarations
|Beneficiaries in traditional Medicare and Medicare Advantage pay no cost sharing for COVID-19 at-home testing (up to eight tests per month), testing-related services, and certain treatments.||End of § 319 PHE||Millions of people have received free COVID-19 testing and testing-related services, certain treatments, and vaccines during the § 319 PHE, but not all of these items will continue to be free when the PHE ends.
For people without insurance, there will no longer be a pathway through Medicaid for free COVID-19 testing, vaccines, or treatment.
Medicare beneficiaries will face cost sharing requirements for at-home tests, testing-related services, and all COVID-19 treatments when the § 319 PHE ends. Coverage of COVID-19 vaccines will continue at no cost due to statutory changes made by the CARES Act that added coverage of COVID-19 vaccines to Medicare Part B. Clinical diagnostic testing is also covered at no cost.
For Medicaid and CHIP enrollees, state Medicaid programs can choose to continue to cover COVID-19 testing, treatment, and vaccines for most adults after federal coverage requirements related to the § 319 PHE expire.
Privately insured individuals could incur additional out-of-pocket costs for tests and related services when the § 319 PHE ends. People with private insurance will continue to have coverage of COVID-19 vaccines at no cost from in-network providers, due to statutory changes made by the CARES Act that extended the requirement under private insurance for coverage of preventive services at no cost to include COVID-19 vaccines.
People with private insurance who receive COVID-19 vaccines, including booster doses, from out-of-network providers could incur out-of-pocket costs when the § 319 PHE ends.
|MEDICAID AND CHIP|
|Enrollees receive coverage of COVID-19 vaccines and vaccine administration without cost sharing.||Last day of first calendar quarter beginning one year after end of § 319 PHE|
|Enrollees receive coverage of coronavirus testing and COVID-19 treatment services without cost sharing. States receive enhanced federal matching funds if they meet the conditions described below.||Last day of calendar quarter in which § 319 PHE ends, except that treatment services must be covered for enrollees in alternative benefit plans through the last day of the first calendar quarter beginning one year after end of § 319 PHE|
|New eligibility pathway to cover COVID-19 testing and testing-related, vaccinations, and treatment services for uninsured individuals; coverage group elected at state option with 100% federal matching funds.||End of § 319 PHE|
|PRIVATE HEALTH INSURANCE|
|Group health plans and individual health insurance plans are required to cover COVID-19 tests and testing-related services without cost sharing or prior authorization or other medical management requirements.
Beginning January 15, 2022, this requirement applies to over-the-counter (OTC) COVID-19 tests authorized, cleared, or approved by the FDA. Health plans must cover up to 8 free OTC at-home tests per covered individual per month, and no physician’s order or prescription is required. Plans may limit reimbursement to no less than the actual or negotiated price or $12 per test (whichever is lower). Plans can set up a network of providers, such as pharmacies or retailers, to provide OTC tests for free rather than having patients to pay up front and submit claims for reimbursement, but the coverage requirement applies whether or not consumers get tests from participating providers.
|End of § 319 PHE|
|For tests and related services furnished by out of network providers, group health plans and individual health insurance (including grandfathered plans) shall reimburse the provider either at a negotiated rate or, if no rate is negotiated, at an amount equal to the cash price posted online by the provider.||End of § 319 PHE|
|Plans and issuers must cover COVID-19 vaccines without cost sharing when provided by out-of-network providers and must reimburse out-of-network providers a reasonable amount for vaccine administration; federal regulations specify the Medicare reimbursement rate for vaccine administration is a reasonable amount.||End of § 319 PHE|
|States receive a 6.2 percentage point increase in their regular federal matching rate (FMAP) if they meet the following conditions:
||For continuous enrollment: last day of month in which § 319 PHE ends
For other provisions: last day of calendar quarter in which § 319 PHE ends
|The continuous enrollment requirement contributed to Medicaid enrollment growth of 20.5% between February 2020 and November 2021.
Millions of people could lose Medicaid coverage and/or potentially face higher costs for Medicaid coverage when the § 319 PHE ends. In 20 states able to report, it is estimated that about 13% of Medicaid enrollees will be disenrolled when the continuous enrollment requirement ends. CMS guidance emphasizes promoting continuity of coverage and avoiding inappropriate coverage terminations when the continuous coverage requirement ends.
State spending on Medicaid is likely to increase when the enhanced FMAP ends
|Among the major changes to Medicare coverage of telehealth during the PHE:
||The Consolidated Appropriations Act of 2022 extended these flexibilities for 151 days beginning on the first day after the end of the § 319 PHE||Expanded coverage of telehealth during the PHE has enabled millions of people to access health care services that they might otherwise have foregone during the pandemic.
For example, over 28 million Medicare beneficiaries used telehealth during the first year of the pandemic, and telehealth accounted for 12% of all services used by beneficiaries during the first year of the pandemic.
Absent permanent changes to Medicare coverage, most Medicare beneficiaries will lose access to coverage of nearly all telehealth services on the 152nd day after expiration of the § 319 PHE, unless they reside in rural areas or enroll in Medicare Advantage.
Based on changes in the Consolidated Appropriations Act of 2021, Medicare has permanently removed geographic restrictions for mental health and substance use services and permanently allows beneficiaries to receive those services at home. Medicare also now permanently covers audio-only visits for mental health and substance use services.
As of summer 2021, post-pandemic Medicaid telehealth policies were under consideration in most states, with many states planning to maintain all or some expanded telehealth policies that were adopted during the COVID-19 pandemic. In states that choose not to continue these policies, however, enrollees may lose access to telehealth services.
|Federally qualified health centers and rural health clinics can provide telehealth services to Medicare beneficiaries (i.e., can be distant site providers), rather than limited to being an originating site provider for telehealth (i.e., where the beneficiary is located)||The Consolidated Appropriations Act of 2022 extended this flexibility for 151 days beginning on the first day after the end of the § 319 PHE|
|MEDICAID AND CHIP|
|All 50 states and DC expanded coverage and/or access to telehealth services in Medicaid. States have broad authority to cover telehealth in Medicaid and CHIP without federal approval, including flexibilities for allowable populations, services and payment rates, providers, technology, and managed care requirements.||Various; may be tied to federal and/or state public health emergencies. Many states have made some Medicaid telehealth flexibilities permanent.|
|All states and D.C. temporarily waived some aspects of state licensure requirements, so that providers with equivalent licenses in other states could practice via telehealth.||Various; in some states; these waivers are still active and tied to the end of § 319 PHE, in others they have expired. Some states have made allowances for long-term or permanent interstate telemedicine.|
|HHS waived potential penalties for HIPAA violations against health care providers that serve patients in good faith through everyday communications technologies during the COVID-19 nationwide public health emergency, which allows for widely accessible services like FaceTime or Skype to be used for telemedicine purposes, even if the service is not related to COVID-19.||End of § 319 PHE|
|DEA-registered providers can use telemedicine to issue prescriptions for controlled substances to patients without an in-person evaluation, if they meet certain conditions.||End of § 319 PHE, unless DEA specifies an earlier date|
|Disaster-Relief State Plan Amendments (SPAs) allow HHS to approve state requests to make temporary changes to address eligibility, enrollment, premiums, cost-sharing, benefits, payments, and other policies differing from their approved state plan during the COVID-19 emergency. States may not make changes that restrict or limit payment, services, or eligibility or otherwise burden beneficiaries and providers. Approved Disaster-Relief SPAs as of July 1, 2021 are listed in KFF’s Medicaid Emergency Authority Tracker||End of § 319 PHE or earlier date selected by state||All 50 states and DC have used these Medicaid emergency authorities to address pandemic-related challenges for providers and enrollees, such as by:
Although these authorities expire at different times related to the PHE, states can choose to continue some changes even after the emergency ends.
Absent state actions to do so would decrease beneficiary access to services and support for providers.
|COVID-19 Section 1115 demonstration waivers allow HHS to approve state requests to operate Medicaid programs without regard to specific statutory or regulatory provisions to furnish medical assistance in a manner intended to protect, to the greatest extent possible, the health, safety, and welfare of individuals and providers who may be affected by COVID-19. Approved COVID-19 Section 1115 waivers as of July 1, 2021 are listed in KFF’s Medicaid Emergency Authority Tracker||60 days after § 319 PHE ends or earlier date approved by CMS|
|Section 1135 waivers allow HHS to approve state requests to waive or modify certain Medicare, Medicaid, and CHIP requirements to ensure that sufficient health care items and services are available to meet the needs of enrollees served by these programs in affected areas. Approved Section 1135 waivers for Medicaid as of July 1, 2021 are listed in KFF’s Medicaid Emergency Authority Tracker||No later than the end of
§ 319 PHE
|Section 1915(c) Appendix K waivers allow HHS to approve state requests to amend Section 1915(c) or Section 1115 HCBS waivers to respond to an emergency. For example, states can modify or expand HCBS eligibility or services, modify or suspend service planning and delivery requirements, and adopt policies to support providers. Approved Section 1915(c) Appendix K waivers as of July 1, 2021 are listed in KFF’s Medicaid Emergency Authority Tracker||No later than six months after § 319 PHE ends|
|For the treatment of patients diagnosed with COVID-19, hospitals receive a 20% increase in the Medicare payment rate through the hospital inpatient prospective payment system.||End of § 319 PHE||Hospitals will no longer receive the 20% payment increase for discharges of patients diagnosed with COVID-19 when the § 319 PHE expires.
Between January 2020 and November 2021, Medicare payment for the approximately 1 million beneficiaries in traditional Medicare hospitalized for COVID-19 hospitalizations over this time period totaled $23.4 billion, or just over $24,000 per patient
|The 3-day prior hospitalization requirement is waived for skilled nursing facility (SNF) stays for those Medicare beneficiaries who need to be transferred because of the effect of a disaster or emergency. Beneficiaries who may have recently exhausted their SNF benefits can have renewed SNF coverage without first having to start a new benefit period.||No later than the end of
§ 319 PHE
|Medicare beneficiaries will again need to satisfy the 3-day prior hospitalization requirement in order to have Medicare coverage of SNF stays when the § 319 PHE expires.|
|Medicare Advantage plans are required to cover services at out-of-network facilities that participate in Medicare, and charge enrollees who are affected by the emergency and who receive care at out-of-network facilities no more than they would face if they had received care at an in-network facility.||Per CMS’s recently proposed revision to Medicare regulations, ends 30 days after the latest applicable end date of § 319 PHE, § 564 national emergency, or state disaster declaration (when multiple declarations apply to the same geographic area), i.e., ends when all sources that declared a disaster or emergency that include the service area have declared an end; or there is no longer a disruption to access of health care||Medicare Advantage enrollees who have been protected from higher out-of-pocket costs associated with services received from out-of-network providers could face higher costs when the § 319 PHE expires.|
|Medicare Part D plans (both stand-alone drug plans and Medicare Advantage drug plans) must provide up to a 90-day (3 month) supply of covered Part D drugs to enrollees who request it.||End of § 319 PHE||Part D plans will no longer be required to issue extended supplies for all Part D drugs they cover after the § 319 PHE ends. Under policies in place in 2020 prior to the pandemic, most Part D enrollees were in plans that covered extended supplies of generic drugs, but only a small share had access to extended supplies of specialty drugs.|
|Section 1135 waivers allow the Secretary of the Department of Health and Human Services to waive certain program requirements and conditions of participation to ensure that Medicare beneficiaries can obtain access to benefits and services.
CMS has issued many blanket waivers and flexibilities for health care providers that are in effect during the COVID-19 PHE to prevent gaps in access to care for beneficiaries impacted by the emergency.
|No later than the end of
§ 319 PHE
|Normal rules and regulations for Medicare program requirements and conditions of participation will apply to all applicable providers and suppliers once the PHE ends.|
|Extension of election and notice deadlines for COBRA, other group health plan provisions: group health plans subject to ERISA or the Internal Revenue Code must disregard “the Outbreak Period” (defined as the period beginning March 1, 2020 and ending 60 days after the end of the COVID-19 National Emergency, or such other end date announced) in determining the following periods and dates:
||60 days after the end of the § 201 national emergency||Statutory timeframes would resume 60 days after the end of the § 201 national emergency. These timeline extensions may have been more beneficial when the temporary COBRA subsidies were in effect, but those have now expired.|
|The FDA has issued EUAs for hundreds of COVID-19 tests, numerous COVID-19 treatments, including antiviral agents and monoclonal antibodies, and three COVID-19 vaccines (Pfizer, Moderna, and Johnson & Johnson). EUAs allow medical countermeasures to be available to the public before formal FDA approval.||End of § 564 emergency declaration (to be determined by the Secretary)||Any COVID-19 medical countermeasure still under an EUA will no longer available for use. A transition period will allow for disposition of unapproved products covered by EUAs as well as labeling and other material related to unapproved uses of approved products.
As of April 6, 2022, the FDA has approved two COVID-19 vaccines for use among adults (Pfizer: ages 16+, and Moderna: ages 18+), but for younger age groups, use of these vaccines continues to only be allowed under EUAs.
|Liability immunity has been extended to providers based on the PREP Act emergency declaration to allow for greater delivery of and access to medical countermeasures. For example, liability immunity has been extended to:
||End of PREP Act declaration: October 1, 2024||Liability protections will no longer be available unless a state provides such protections and authority under state law.
Without such authority, access would likely be reduced, as many providers would no longer be able to provide medical countermeasures covered by the declaration.