The COVID-19 pandemic made the last three years particularly challenging for healthcare providers and companies. In early 2020, in response to the remarkable strain COVID-19 placed on the US healthcare system, several emergency declarations were made by different branches of the federal government. Those emergency declarations gave the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) the ability to waive regulatory requirements to help providers better meet the challenges of the pandemic.
As time has passed, the dizzying clinical (and resulting regulatory) pace has slowed as COVID-19 has evolved into a more understood and manageable illness. While this is of course a welcome development, it also means that some of the regulatory flexibility provided by the federal government will soon expire as the various COVID-19-related emergency periods come to an end.
Over the duration of the pandemic, some of the temporary waivers issued by the federal government were extended, independent of any emergency declaration, or made permanent by statute. The coming end of the COVID-19 public health emergency means that healthcare providers and companies must assess their operations for any changes that were enabled by any of the emergency waivers to determine whether they will survive. Our experience suggests that once a waiver is operationalized, providers may sometimes continue those operations after the expiration of the waiver because they are either unaware the waiver is no longer in effect or do not understand that the operational change was premised on a temporary waiver. Regulatory noncompliance can and often does result.
This alert will briefly describe the various emergency declarations made in 2020 and discuss some of the regulatory waivers in detail. More broadly, we also include an Appendix that details the post-public health emergency status of many of the more notable federal emergency actions.[1]
Summary of COVID-19 Federal Emergency Declarations and Status
The various federal emergency declarations and their expiration dates are:
- The following expire on May 11, 2023:
- A public health emergency (PHE) declared by the Secretary of HHS on January 31, 2020, pursuant to Section 319 of the Public Health Service Act.
- A national emergency declaration issued by former President Donald J. Trump on March 13, 2020, pursuant to Sections 201 and 301 of the National Emergencies Act.
- An emergency declaration was issued by the Secretary of HHS on February 4, 2020, pursuant to Section 564 of the Federal Food, Drug and Cosmetic Act. The emergency declaration enabled the emergency use authorization (EUA) of medical countermeasures for COVID-19. This Section 564 declaration remains in effect until terminated by the HHS Secretary. It is not among the declarations that will expire on May 11, 2023.
- The Public Readiness and Emergency Preparedness Act (PREP Act) provides immunity from tort liability (except for willful misconduct) for activities related to the manufacture, distribution, or dispensing of medical countermeasures to combat a disease that is determined by HHS to present a public health emergency. Pursuant to Section 319F-3 of the Public Health Service Act, on February 4, 2020, the Secretary of HHS declared COVID-19 to constitute such a public health emergency. This declaration will expire on October 1, 2024.
Telehealth
One of the pandemic’s silver linings was the increase in use of telehealth to help expand patient access to care. In the earlier stages of the pandemic, telehealth offered patients a way to receive care that they may otherwise have decided not to receive in person for fear of exposure to COVID-19 at a facility or practice. To increase access to telehealth, CMS took the following actions:
- Authorized the use of telehealth beyond only rural areas to Medicare beneficiaries in all geographic areas.
- Allowed Medicare beneficiaries to remain in their homes for telehealth visits, rather than requiring them to travel to a healthcare facility.
- Permitted telehealth visits via audio-only equipment (i.e., video capability was no longer necessary).
- Expanded the list of Medicare-covered services that could be provided by telehealth.
- Allowed federally qualified health centers and rural health clinics to provide telehealth services as distant site providers. Previously, FQHCs and rural health clinics could only serve as originating site providers (i.e., the site where the patient is located).
Also, HHS took the following steps:
- Waived penalties for noncompliance with HIPAA in connection with the good faith provision of telehealth, which allowed providers to communicate with patients via widely used services like FaceTime or Skype.
- In cooperation with the federal Drug Enforcement Administration, allowed DEA-registered providers to write prescriptions for controlled substances without first conducting an in-person patient visit.
The Consolidated Appropriations Act, 2023 (CAA) extended all the above telehealth flexibilities granted by CMS through December 31, 2024. Other CMS telehealth waivers, largely focused on behavioral and mental telehealth services, were made permanent.
However, the above HHS waivers will not survive the expiration of the PHE. For its part, the DEA is currently working on regulations that may allow a controlled substance prescription without an in-person patient visit under some circumstances. While that is welcome news to many providers, many providers are finding it difficult to plan for the unknown while we wait to see what flexibility the DEA’s rulemaking might provide.
Acute Hospital Care at Home
Under waivers issued during the PHE, CMS created the Acute Hospital Care at Home (AHCH) program. A hospital that obtains an AHCH program waiver from CMS is permitted to provide services to low-acuity patients in alternative settings (e.g., the home), yet the hospital receives the same reimbursement from Medicare as if the care was provided on an inpatient basis. Among other rules, the waiver relaxed certain Medicare Conditions of Participation otherwise applicable to hospitals. Specifically, the waiver states that the requirement for providing 24-hour nursing services and immediate availability of nursing services may be satisfied by providing 24/7 virtual access to nurses or physicians. Also, hospital physical structure requirements under the life safety code are satisfied when residences are found to be safe and appropriate for the AHCH program’s services. As of January 31, 2023, 260 hospitals have been approved by CMS to operate an AHCH across thirty-seven states.
Under the AHCH program, hospitals must still comply with state licensure requirements. In response to CMS’s creation of the AHCH program, states have implemented correlating flexibilities to allow hospitals to provide acute care at home services while remaining in compliance with state licensure requirements. For example, the California Department of Public Health (CDPH) created its own “Acute Hospital Care at Home Program.” California’s program is specifically conditioned on the existence of the PHE and availability of the CMS waivers. Other state licensing agencies require hospitals to obtain similar approvals or submit a certificate of need to operate these programs.
The CAA extended the AHCH program through December 31, 2024. The CAA, which includes flexibilities and requirements consistent with the CMS waiver, no longer ties the AHCH program to the PHE. Notwithstanding the continuation of the federal program under the CAA, hospitals must remain in compliance with applicable state licensing requirements, which are not addressed by the CAA. The continuation of such state-based flexibilities may not be automatic in states where the flexibilities and related programs are conditioned on the existence of the PHE. For example, in California, hospitals that seek to extend existing programs (or implement new ones) beyond the expiration of the PHE must obtain approval from CDPH. Approval will be granted on a case-by-case basis unless CDPH provides for a blanket extension of the state program.
Looking ahead
Our Healthcare team will continue to monitor the status of the emergency declarations, and other government-issued guidance, that will have an impact on the industry. For the status of any waiver or action not listed here, please contact any of the authors of this alert or your regular Nixon Peabody attorney.
- Please note that neither this alert nor the Appendix is intended as a comprehensive catalog of all federal waivers issued and emergency actions taken during the pandemic.
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Appendix: Status of COVID-19 Notable Emergency Actions Post-May 11, 2023
COVID-19 testing, treatments, and vaccines
Description of emergency action
Medicare Part B and Medicare Advantage beneficiaries pay no cost sharing for:
- Testing-related services (e.g., lab tests, antibody tests),
- Up to 8 at-home COVID-19 tests per month,
- Certain treatments, including monoclonal antibody treatments and oral antivirals (such as Paxlovid), and
- All medically necessary hospitalizations
Relevant cites
- Consolidated Appropriations Act, 2023 (CAA).
- CMS Fact Sheet: Physicians and Other Clinicians: CMS Flexibilities to Fight COVID-19; see also CMS, Calendar Year 2023 Physician Fee Schedule.
Post-emergency declaration status
- When the PHE expires, Medicare will no longer waive Medicare Part B and Medicare Advantage beneficiary cost sharing for COVID-19 testing, certain treatments, oral antivirals, and hospitalizations.
- Certain authorized prescription oral antiviral drugs will be covered as a Part D drug through the end of 2024.
- Beginning in 2024, in-home intravenous immune globulin services and certain lymphedema compression treatments will receive coverage.
- When the PHE expires, CMS will:
- Continue to pay approximately $40 per dose for administering COVID-19 vaccines in outpatient settings for Medicare beneficiaries through the end of 2023.
- Continue to pay a total payment of approximately $75 per dose ($40 plus $35.50 at-home payment) to administer COVID-19 vaccines in the home for certain Medicare patients through the end of 2023.
- Effective January 1, 2024, CMS will set the payment rate for administering COVID-19 vaccines to align with the payment rate for administering other Part B preventive vaccines.
Description of emergency action
Medicaid and CHIP expanded to provide:
- Coverage of COVID-19 vaccines and vaccine administration without cost sharing.
- Coverage of COVID-19 testing, including at-home, and COVID-19 treatment services without cost sharing.
- New eligibility pathway to cover COVID-19 testing and testing-related, vaccinations, and treatment services for uninsured individuals; and state receives 100% federal matching funds for newly eligible coverage group.
Relevant cites
Post-emergency declaration status
- Medicaid and CHIP will cover all Advisory Committee on Immunization Practices-recommended vaccines for adults, including COVID-19 vaccines, and vaccine administration without cost sharing.
- Enrollees will receive coverage of COVID-19 testing through September 30, 2024.
- Alternative eligibility pathways for uninsured enrollees terminate with end of PHE.
Description of emergency action
Private group health plans and individual health plans are required to
- Cover COVID-19 tests and testing-related services without cost sharing or prior authorization, including at least 8 over-the-counter COVID-19 tests.
- Reimburse out-of-network providers for tests and related services.
- Cover COVID-19 vaccines without cost sharing even when provided by out-of-network providers and must reimburse out-of-network providers a reasonable amount for vaccine administration.
Health plans may limit reimbursement to $12 per test and set up a network of providers to provide free tests.
Relevant cites
- Families First Coronavirus Response Act (FFCRA) (§ 6001(a)(1)).
- Coronavirus Aid, Relief and Economic Security Act (CARES)
Post-emergency declaration status
- Private health plans may require their members to pay certain cost sharing amounts and require prior authorizations for COVID-19 testing, treatments, and related services.
- Private plans are no longer required to:
- reimburse out-of-network providers for diagnostic testing or a “qualifying coronavirus preventative service” (i.e., vaccination).
- cover COVID-19 vaccines when provided by out-of-network providers without cost sharing nor are private plans required to reimburse out of network providers.
Telehealth
Description of emergency action
Through a Social Security Act Section 1135 waiver, CMS implemented the following telehealth flexibilities:
- Medicare beneficiaries in any geographic area can receive telehealth services, rather than beneficiaries living in rural areas only.
- Beneficiaries can remain in their homes for telehealth visits reimbursed by Medicare, rather than needing to travel to a healthcare facility.
- Telehealth visits can be delivered via smartphone in lieu of equipment with both audio and video capability.
- An expanded list of Medicare-covered services can be provided via telehealth.
- Telehealth services can be provided by a physical therapist, occupational therapist, speech language pathologist, or audiologist.
- Federally qualified health centers and rural health clinics are no longer limited to functioning as originating site providers for telehealth (i.e., where the patient is located). FQHCs and rural health clinics can now provide telehealth services to Medicare beneficiaries (i.e., can be distant site providers).
Relevant cites
Consolidated Appropriations Act, 2023 (CAA)
Post-emergency declaration status
The CAA severs these measures from the PHE and extends them through 12/31/2024.
Description of emergency action
All 50 states and D.C. 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.
Relevant cites
State Medicaid Telehealth Policies Before and During the COVID-19 Public Health Emergency
Post-emergency declaration status
Varies by state/territory: May be tied to federal and/or state public health emergencies. Most states have made, or plan to make, some Medicaid telehealth flexibilities permanent. Information related to the state-by-state expiration of these expanded coverages can be found using this map.
One example is New York’s pending application for a Section 1115 waiver that includes funding for telehealth infrastructure, including to equip skilled nursing facilities with telehealth equipment for their Medicaid residents, to provide telehealth kiosks to homeless shelters, and to supply tablets to providers and enrollees who lack access to technology necessary for telehealth services (with requested waiver effective date of 1/1/2023).
Description of emergency action
All states and D.C. temporarily waived some aspects of state practitioner licensure requirements, so that practitioners with equivalent licenses in other states could practice across state lines via telehealth.
Relevant cites
U.S. States and Territories Modifying Requirements for Telehealth in Response to COVID-19
Post-emergency declaration status
Varies by state/territory: information as to when specific states’ waiver of licensure requirements expires can be found using this map.
Description of emergency action
HHS waived potential penalties for HIPAA violations against healthcare providers that serve patients in good faith through everyday communications technologies, which allowed for widely accessible services like FaceTime or Skype to be used for telemedicine purposes, even if the service was not related to COVID-19.
Relevant cites
Post-emergency declaration status
Ends with PHE.
Description of emergency action
DEA-registered providers can use telemedicine to issue prescriptions for controlled substances to patients without an in-person evaluation, if they meet certain conditions.
Relevant cites
Post-emergency declaration status
Ends with PHE, unless DEA specifies an earlier date.
DEA is working on regulations that will in certain circumstances continue to allow controlled substance prescribing without an in-person evaluation.
Medicare Payment and Coverage Flexibilities
Emergency Action
Waivers allowing a 20% increase in the Medicare payment rate for an individual diagnosed with COVID-19 discharged during the PHE period through the hospital inpatient prospective payment system.
Relevant Cites
- Section 3710 of the CARES Act (Pub. L. 116-136).
- July 2020 Quarterly Update to the Inpatient Prospective Payment System (IPPS) (Guidance from CMS notes that “additional instructions will be issued once the COVID-19 public health emergency period has concluded”).
- New Waivers for Inpatient Prospective Payment System (IPPS)
Post-emergency Declaration Status
The waivers will expire on May 11, 2023. Additional instructions will be issued by CMS once the PHE has concluded.
Emergency Action
Waiver of the SNF 3-Day Rule, which requires 3 days of prior hospitalization for Medicare beneficiaries before Medicare will pay for the SNF stay, for patients who need to be transferred to an SNF because of a disaster or an emergency. In addition, for certain beneficiaries who have exhausted their SNF benefits, the waivers authorize one-time renewed coverage without the beneficiary having to complete the usually required 60-day wellness period.
Relevant Cites
- 42 U.S.C. § 1395d; 42 C.F.R. § 425.612.
- Medicare Shared Savings Program SNF Waiver
- COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers
- Long Term Care Facilities (Skilled Nursing Facilities and/or Nursing Facilities): CMS Flexibilities to Fight COVID-19
Post-emergency Declaration Status
The waivers are only available during the PHE and will expire no later than May 11, 2023.
Emergency Action
Waivers to require Medicare Advantage plans to cover services at out-of-network facilities that participate in Medicare, and charge enrollees who receive care at out-of-network facilities no more than an in-network facility.
Relevant cites
- 42 C.F.R. § 422.100(m); Department of Health & Human Services, Centers for Medicare & Medicaid Services April 21, 2020, letter to All Medicare Advantage Organizations, Part D Sponsors, and Medicare-Medicaid Plans; Section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C) Act (21 U.S.C. 360bbb-3).
- Special Requirements During a Disaster or Emergency for Medicare Advantage Plans
Post-emergency declaration status
The waivers end 30 days after the latest applicable end date of the PHE (May 11, 2023), § 564 national emergency, or state disaster declaration (when multiple declarations apply to the same geographic area).
Emergency Action
Waivers to require Medicare Part D plans to provide up to a 90-day supply of covered Part D drugs (as defined in 42 C.F.R. § 423.100) to enrollees who request it during the PHE.
Relevant cites
- Section 3714 of the CARES Act (Pub. L. 116-136), https://www.congress.gov/116/bills/hr748/BILLS-116hr748enr.pdf.
- CMS Letter to All Medicare Advantage Organizations, Part D Sponsors, and Medicare-Medicaid Plans.
Post-emergency declaration status
The waivers will expire no later than May 11, 2023.
Emergency Action
HHS issued Section 1135 waivers to temporarily waive certain Medicare program requirements and conditions of participation to ensure that Medicare beneficiaries can obtain access to benefits and services.
Examples include:
- Waiver of EMTALA enforcement
- Elimination of the 30-day timeframe for completion of medical records in a hospital
- Waiver of certain staffing and physician supervision requirements for FQHCs and rural health clinics
- Waiver of skilled nursing facility residents’ rights in certain circumstances to share a room with a roommate of choice, to refuse transfer to another room in the facility and other transfer and discharge rights
- Permitting home health agencies to perform initial assessments and determination of homebound status remotely or by record review
- Across the spectrum of providers, relaxation of quality assurance program requirements, training and in-service mandates, reporting requirements, utilization review, and credentialing rules.
Relevant cites
- COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers
- Section 1135 Waiver Flexibilities
Post-emergency declaration status
Waivers under Section 1135 generally expire at the end of the emergency declaration, although the Secretary can grant a waiver for 60 days, even if that 60 days extends beyond the end of the emergency declaration.
Acute care at home
Emergency Action
In March 2020, CMS announced the Hospital Without Walls program, which provided broad regulatory flexibility that allowed hospitals to provide services in alternative care settings, including the home. In November 2020, CMS expanded this program under the Acute Hospital Care at Home waiver, an individual waiver that provided flexibility for several Medicare requirements, and as a result, allowed hospitals to deliver care to patients in an in-home setting and receive the same reimbursement from Medicare as for traditional inpatient services.
Relevant cites
- CMS Flexibilities: Hospitals and CAHs, ASCs and CMHCs (Feb. 1, 2023)
- Consolidated Appropriations Act, 2023 (CAA)
- Acute Hospital Care at Home - CMS Overview (Updated based on CAA)
- CDPH, Program Flexibility Requirement for General Acute Care Hospitals (GACH) Before Providing Acute Hospital Care at Home Services (December 23, 2020)
- CDPH All Facilities Letter 20-26.13
Post-emergency declaration status
Under the CAA, the Acute Hospital Care at Home program flexibilities were extended at the federal level until December 31, 2024.
The CAA does not address state licensure requirements, meaning that state licensing authorities may need to take action to extend these programs at the state level or provide other flexibility to hospitals to continue program activities.
Medicaid coverage and federal match rates
Emergency Action
States receive a 6.2% increase in their regular federal matching rate (FMAP) if they meet the following conditions:
- Cover coronavirus testing and COVID-19 treatment services, including vaccines, specialized equipment, and therapies, without cost sharing.
- Continuous enrollment: states generally must provide continuous eligibility for individuals enrolled in Medicaid on or after 3/18/2020; states may not transfer an enrollee to another coverage group that provides a more restrictive benefit package.
- Maintenance of eligibility standards: states must not implement more restrictive eligibility standards, methodologies, or procedures than those in effect on 1/1/2020.
- No increases to premiums: states must not adopt higher premiums than those in effect on 1/1/2020.
Maintenance of political subdivisions’ contributions to non-federal share of Medicaid costs: states must not increase political subdivisions’ contributions to the non-federal share of Medicaid costs beyond what was required on 3/1/2020.
Relevant cites
- Families First Coronoavirus Response Act (FFCRA)
- The Consolidated Appropriations Act, 2023 (CAA)
- Medicaid Continuous Enrollment Condition Changes, Conditions for Receiving the FFCRA Temporary FMAP Increase, Reporting Requirements, and Enforcement Provisions in the Consolidated Appropriations Act, 2023
Post-emergency declaration status
For continuous enrollment: the CAA separates the continuous enrollment condition from the end of the COVID-19 PHE to end continuous Medicaid enrollment as a condition for claiming the temporary FMAP increase on 3/31/2023. This means that, on or after 4/1/2023, states claiming the temporary FMAP increase will no longer be required to maintain the enrollment of a Medicaid beneficiary for whom the state completes a renewal and who no longer meets Medicaid eligibility requirements. The CAA also phases down the enhanced federal funding through 12/31/2023, according to the following schedule:
- For each calendar quarter from now until 3/31/2023, 6.2 percentage points
- For the calendar quarter that begins on 4/1/2023, and ends on 6/30/2023, 5 percentage points
- For the calendar quarter that begins on 7/1/2023, and ends on 9/30/2023, 2.5 percentage points
- For the calendar quarter that begins on 10/1/2023, and ends on 12/31/2023, 1.5 percentage points
For all other conditions: The CAA keeps each of the conditions from the FFCRA for receiving the enhanced FMAP (besides the continuous enrollment condition) and adds the following conditions to enroll during the phasing out period:
- Complying with Federal Eligibility Renewal Requirements: states must conduct eligibility redeterminations and renewals in compliance with federal regulatory requirements at 42 C.F.R. 435.916
- Obtaining Up-to-Date Contact Information Prior to Redetermination
- Conducting Multiple Modality Outreach Based on Returned Mail Prior to Termination: states must make a good faith effort to contact an individual using 2 modalities before terminating enrollment based on mail returned to the state in response to a redetermination.
- Modified Premium Increase Condition: Beginning 4/1/2023, states may increase individual premiums for enrollees while still claiming the temporary FMAP bump as long as they: ensure consistency with their Medicaid premium schedule; do not increase the premium schedule amounts over the amounts in effect as of 1/1/2020; and comply with redetermination requirements prior to resuming premiums as well as other federal requirements.
Fraud and abuse flexibility for COVID-19-related financial arrangements
Emergency Action
On March 30, 2020, CMS issued a Social Security Act Section 1135 waiver applicable to certain portions of the Stark Law. To be eligible, a financial arrangement must be “solely related to Covid-19 [p]urposes.” There are 6 permitted purposes:
- To diagnose or treat COVID-19
- To secure the services of physicians and other health care professionals to furnish medically necessary patient care, including services unrelated to COVID-19
- To ensure the ability of providers to address patient and community needs arising out of COVID-19 (note that this is a very broad purpose)
- To expand the capacity of providers to address patient and community needs in response to the COVID-19 outbreak
- To shift diagnosis and care of patients to appropriate alternative settings due to the COVID-19 outbreak
- To address practice or business interruption due to the COVID-19 outbreak to maintain the availability of medical care and related services for patients and the community
If a financial arrangement with a referring physician has one of the above purposes, certain otherwise applicable requirements do not apply. Examples include:
- Under some circumstances, the requirement that services agreements, office leases, and equipment leases involve fair market value compensation
- The cap on medical staff incidental benefits and nonmonetary compensation
- The requirement that certain financial arrangements be in writing and fully executed
Relevant cites
Post-emergency declaration status
The waivers are coterminous with the PHE and 201/301 emergency declaration (i.e., they will end on May 11, 2023).
Emergency Action
In April of 2020, the OIG invited questions from stakeholders as to how OIG would view a given arrangement that was “directly connected” to the PHE and implicated the Anti-Kickback Statute or the Civil Monetary Penalties Law (prohibited inducements to federal healthcare program beneficiaries). OIG could then decide to respond by publishing guidance in the form of a FAA on its website.
This process resembles a more streamlined OIG advisory opinion process, with the critical distinction that a FAQ does not bind the OIG or the requesting party(ies).
Relevant cites
Post-emergency declaration status
OIG conditioned its FAQs on the PHE. OIG may take a different position on the same or similar arrangements after the PHE expires on May 11, 2023.
Medicaid and CHIP flexibilities
Emergency Action
Disaster-Relief State Plan Amendments (SPAs) allow HHS to approve state requests for temporary changes to their approved state plan during the PHE. States can request temporary changes to policies related to eligibility, enrollment, appeals, premiums and cost sharing, benefits, prescription drug, telehealth, payments, providers and oversight.
Relevant cites
- Secretary’s Determination that a Public Health Emergency Exists
- Request for Waivers under Section 1135
- COVID-19 Frequently Asked Questions (FAQs) for State Medicaid and Children’s Health Insurance Program (CHIP) Agencies
Post-emergency declaration status
The state plan amendments are only available during the PHE and will expire on May 11, 2023, or at an earlier date selected by each state.
Emergency Action
COVID-19 Section 1115 Demonstration Waivers developed by CMS to allow states to select different options for delivering the most effective care to beneficiaries as a result of the PHE
Relevant cites
- Department of Health & Human Services, Centers for Medicare & Medicaid Services March 22, 2020 letter to State Medicaid Directors (SMDL # 20-002)
- COVID-19 Section 1115(a) Demonstration Application Letter and Template
- COVID-19 Frequently Asked Questions (FAQs) for State Medicaid and Children’s Health Insurance Program (CHIP) Agencies
Post-emergency declaration status
The waivers are only available during the PHE and will expire no later than 60 days after May 11, 2023.
Emergency Action
Section 1915(c) Appendix K waivers allow states to request amendments to approved 1915(c) Home and Community-Based Services (HCBS) waivers during the PHE. The waiver relates to actions that states can take under the existing Section 1915(c) HCBS waiver authority in order to respond to an emergency.
Relevant cites
- Emergency Preparedness and Response for Home and Community Based (HCBS) 1915(c) Waivers
- COVID-19 Frequently Asked Questions (FAQs) for State Medicaid and Children’s Health Insurance Program (CHIP) Agencies
Post-emergency declaration status
The waivers are only available during the PHE and will expire no later than 6 months after PHE ends, or at an earlier date selected by each state.
Private insurance coverage flexibilities
Emergency Action
Extension of election and notice deadlines for COBRA
Relevant cites
Post-emergency declaration status
The waivers expire upon termination of the § 201/301 national emergency, which will be May 11, 2023.
Liability immunity to administer COVID-19 countermeasures
Emergency Action
- Under PREP Act, when the Secretary determines that a threat or condition constitutes a present or credible risk of a future public health emergency, the Secretary may issue a PREP Act declaration.
- A PREP declaration provides a covered person with immunity from liability (except for willful misconduct) for claims of loss caused by, arising out of, relating to, or resulting from the administration or use of covered countermeasures to diseases, threats, and conditions identified in the declaration.
- Covered Persons include:
- manufacturers, distributors, states, localities, licensed healthcare professionals, and
- others identified by the Secretary who administer COVID-19 countermeasures (e.g., licensed healthcare professionals who cross state borders, federal response teams, previously active/recently retired health professionals and students).
- The PREP Act Declaration preempts state requirements that would result in a qualified person being unable to prescribe, dispense, or administer vaccines, except those states with less restrictive licensing laws.
Relevant cites
Public Readiness and Emergency Preparedness Act (PREP); see also PREP Act Immunity from Liability for COVID-19 Vaccinators.
Post-emergency declaration status
- Liability immunity survives the expiration of the PHE and continues until October 1, 2024, as set forth under the 2020 PREP Act Declaration.
- The 2020 PREP Act Declaration provides manufacturers with an additional 12 months of liability protection to allow for the manufacturer(s) to arrange for disposition of covered countermeasure(s), including return of the covered countermeasures to the manufacturer, and for Covered Persons to take such other actions as are appropriate to limit the administration or use of a covered countermeasure.
Access to medical countermeasures through FDA Emergency Use Authorization
Emergency Action
The FDA has issued Emergency Use Authorization (EUA) for COVID-19 tests, COVID-19 treatments, including antiviral agents and monoclonal antibodies, and COVID-19 vaccines, which allow medical countermeasures to be available to the public before formal FDA approval.
Relevant cites
Post-emergency declaration status
The waivers expire upon termination of the § 564 emergency declaration. The timing to conclude the EUA is to be determined; it will not conclude on May 11, 2023, with the other declarations.