The Biden Administration has announced that May 11, 2023, will be the final day of the COVID-19 public health emergency (PHE) declaration, which has been in effect since January 2020. Following the White House’s announcement on January 30, the U.S. Department of Health & Human Services (HHS) followed up on February 9 by renewing the PHE for a final 90-day term (effective February 11 through May 11) and issuing the COVID-19 Public Health Emergency Transition Roadmap that outlines some of the many implications of the PHE’s upcoming expiration. The PHE declaration itself has enabled HHS to invoke certain emergency powers, and over the course of the pandemic, both Congress and the Biden Administration have linked various other pandemic-related flexibilities and mandates to the PHE timeline. Certain pandemic-related policies have already been terminated, while others remain in effect, albeit on a temporary basis.
This newsletter identifies some of the key emergency measures with expiration dates that are linked to the PHE, as well as measures with expiration timelines that are not tied to the PHE.
Emergency COVID-19 Measures With Timelines Linked to the PHE
The following policies are generally scheduled to expire at the same time as the PHE (i.e., after May 11, 2023) or shortly thereafter:
Section 1135 Waivers. The Section 1135 waivers relax numerous federal requirements for health care providers that participate in the federal Medicare or Medicaid programs and also for state Medicaid agencies. Among the many “blanket” 1135 waivers issued by the Centers for Medicare & Medicaid Services (CMS) are waivers that enable alternative sites of care, clinician practice across state lines, staffing flexibilities for hospitals and long-term care facilities, and the ability for hospitals to establish skilled nursing facility (SNF) “swing beds.” In addition, individual state Medicaid programs received waivers of federal requirements concerning, e.g., the timelines and procedures for beneficiary and provider enrollment, appeals, and the provision of home and community-based services (HCBS). Most of these 1135 waivers will terminate at the end of the PHE, although for certain waivers, CMS has authorized grace periods following the end of the PHE.1 CMS has released provider-specific documents summarizing active waivers and identifying expiration timelines.
SNF Three-Day Rule. Normally, Medicare will cover an extended SNF stay only if it follows a hospital inpatient stay of at least three consecutive days. During the PHE, CMS waived this three-day requirement. This waiver will expire at the end of the PHE.
HIPAA Enforcement Discretion. The HHS Office for Civil Rights (OCR) issued guidance relaxing certain federal HIPAA privacy and security rules during the PHE, including with respect to permissible telehealth technologies, community-based testing sites and web-based scheduling of COVID-19 vaccine appointments. Those flexibilities are generally set to expire at the end of the PHE, although OCR released guidance in July 2022 discussing permissible post-PHE options for telehealth.
Flexibilities Concerning Health Care Fraud and Abuse. During the PHE, CMS used Section 1135 to relax various restrictions under the Physician Self-Referral Law (commonly referred to as the Stark Law). In addition, the HHS Office of Inspector General (OIG) issued guidance condoning, for the duration of the PHE, certain COVID-19 response activities that might otherwise raise concerns under the Anti-Kickback Statute. These flexibilities are all scheduled to sunset at the end of the PHE.
Certain State Medicaid and CHIP Operational Flexibilities. In response to COVID‑19, CMS allowed states to rapidly implement various time-limited changes to their Medicaid program and Children’s Health Insurance Program (CHIP). Many of these changes will expire at the end of the PHE or shortly thereafter, including program modifications implemented via a Disaster Relief State Plan Amendment (SPA), a COVID‑19 1115 demonstration project or a so-called Appendix K filing with respect to an HCBS waiver.2
Coverage of COVID-19 Tests Without Cost Sharing. During the PHE, enrollees in Medicare, Medicaid, CHIP and private health insurance received coverage of COVID-19 tests and testing-related services without cost sharing (and, for commercial enrollees, without prior authorization requirements). With the conclusion of the PHE comes the end of no-cost COVID-19 testing for many patients, including the eight free at-home tests Medicare beneficiaries and commercially insured patients were eligible to receive each month. For Medicaid and CHIP, however, states must continue covering COVID‑19 testing without cost sharing until September 30, 2024 (i.e., one year plus one calendar quarter following the end of the PHE), at which point states could begin imposing cost sharing. This coverage requirement was established under the American Rescue Plan Act (ARP) of 2021.
Flexibilities Concerning Controlled Substances. The Ryan Haight Online Pharmacy Consumer Protection Act generally requires practitioners to see a patient in person before prescribing controlled substances, including buprenorphine, one medication used to treat opioid use disorder (MOUD). During the PHE, authorized providers have been able to prescribe buprenorphine and other controlled substances without an in-person visit pursuant to waivers from the Drug Enforcement Administration (DEA), which regulates controlled substances, and the Substance Abuse and Mental Health Services Administration (SAMHSA), which regulates opioid treatment programs. The DEA has indicated that it will pursue rulemaking to allow telehealth providers to continue to prescribe controlled substances after the PHE concludes, which, in conjunction with a SAMHSA proposed rule, would continue the PHE era’s expanded access to MOUD.
Emergency Policies Whose Expiration Timelines Are Not Linked to the PHE
While a number of emergency measures are linked to the PHE’s timeline, as noted above, several other notable policies have expiration timelines unrelated to the PHE, including the following:
Medicaid Continuous Coverage. The Families First Coronavirus Response Act of 2020 (FFCRA) offered states a 6.2-point bump in their federal Medicaid match rate subject to certain conditions, including a prohibition on terminating benefits for any Medicaid enrollee during the PHE. In the recently enacted Consolidated Appropriations Act, 2023 (CAA), Congress uncoupled the so-called continuous coverage requirement from the PHE, and instead defined March 31, 2023, as the fixed end date for this requirement; a gradual phasedown schedule for the federal match enhancement; and new conditions, reporting requirements and enforcement mechanisms to prioritize coverage retention and smooth coverage transitions during the “unwinding” period.
Telehealth Flexibilities for Medicare and HDHPs. Although a number of Medicare telehealth flexibilities were originally linked to the PHE timeline, the CAA extends key flexibilities through the end of calendar year 2024, including the following:
- Any site in the United States, including a patient’s home, will be considered an eligible “originating site” for the delivery of telehealth services, although these nontraditional originating sites will not be eligible for telehealth facility fees. Previously, Medicare covered telehealth only for residents of rural areas, and only if they traveled in person to an eligible originating site facility.
- The list of eligible telehealth practitioners will continue to include qualified occupational therapists, physical therapists, speech-language therapists and audiologists.
- Federally qualified health centers and rural health clinics may serve as originating or distant sites for the delivery of telehealth services.
- Providers may offer mental health services via video or audio-only telehealth without needing to satisfy in-person visit requirements.3
- Note: This applies to all sites of care, including federally qualified health centers and rural health centers (except in the case of hospice patients).
- Medicare will continue to cover an expanded list of audio-only telehealth services.
- Practitioners will be able to use telehealth to conduct face-to-face encounters prior to recertification of eligibility for hospice care.
Additionally, high-deductible health plans (HDHPs) that are eligible for health savings accounts may continue to provide pre-deductible coverage for telehealth services through the end of 2024.
Medicare Waivers for Acute Hospital Care at Home. The CAA also extends the Acute Hospital Care at Home initiative through December 31, 2024. As the name suggests, this program allowed hospitals to provide inpatient-level services in patients’ homes, subject to CMS approval and compliance with program requirements.
Coverage of COVID-19 Treatments Without Cost Sharing. To date, the federal government has generally purchased and distributed antiretrovirals and other COVID‑19 treatments to providers free of charge on the condition that the providers administer those treatments to eligible patients free of charge. However, standard coverage and cost-sharing rules will kick in under Medicare and commercial coverage once the federal government ceases federal purchase and distribution (commonly referred to as the “commercialization” of these COVID‑19 products). By contrast, in Medicaid and CHIP, ARP requires states to cover COVID‑19 treatments, without cost sharing, until September 30, 2024 (consistent with the mandate for coverage of COVID‑19 testing, as noted above). (Oral antiviral drugs authorized by the Food and Drug Administration (FDA) under an emergency use authorization will be considered Medicare Part D drugs only until December 31, 2024.)
COVID-19 Vaccines. On a permanent basis, COVID-19 vaccines will be covered with no cost sharing under Medicare, Medicaid and commercial health coverage (potentially subject to provider network requirements), consistent with the CAA (as applicable to Medicare and certain adult Medicaid and CHIP populations) and pre-pandemic laws (as applicable to the commercial market and certain Medicaid and CHIP populations).
The President’s Stafford Act Declarations. These declarations authorize the Federal Emergency Management Agency (FEMA) to disburse disaster relief funds. In addition to a nationwide emergency declaration on March 13, 2020, the President has issued state-by-state major disaster declarations. These declarations all remain in effect as of the time of writing. FEMA will eventually declare an end to the “incident period” related to COVID-19, which will establish the time period during which certain types of expenses will be reimbursed.
HHS Public Readiness and Emergency Preparedness (PREP) Act. HHS’s PREP Act declaration, which went into effect on February 4, 2020, shields certain individuals and entities from liability with respect to the manufacture, distribution, administration or use of drugs, devices and biological products used to diagnose, treat or prevent COVID-19. HHS has, in addition, used the PREP Act to pre-empt certain state laws on licensure and scope of practice, including an authorization for most types of health care practitioners nationwide to order and/or administer COVID-19 vaccines under certain circumstances (as discussed here by Manatt). HHS’s PREP Act declarations and related guidance are available here. The PREP Act declarations will remain in effect through October 1, 2024, unless HHS terminates them sooner.
The FDA’s Emergency Use Authorizations (EUAs). During the pandemic, the FDA has invoked Section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act to issue EUAs that temporarily authorize unapproved medical products, such as drugs, vaccines and devices. If an EUA product does not receive full FDA approval within a year of receiving an EUA, HHS must provide a written “explanation of the scientific, regulatory, or other obstacles to approval, licensure, or clearance.”
Health Care Stakeholders Should Be Mindful of the Expiration Timelines for Key Pandemic Policies
Certain pandemic-related policies have now been in place for over three years, and some health care stakeholders may have come to take them for granted. In light of the White House’s announcement of a PHE end date, providers, state officials and other stakeholders should be sure to identify any temporary flexibilities that continue to factor into their operations, confirm the expiration date for those flexibilities and develop a plan for ensuring compliance with post-pandemic federal requirements.
1 For example, many states received 1135 waivers related to provider enrollment in Medicaid, including waivers allowing for delays in provider revalidation and permitting provisional enrollment of providers that were already enrolled with Medicare or with another state’s Medicaid program. CMS has authorized a six-month grace period for these flexibilities following the end of the PHE, as described in CMS State Health Official Letter (SHO) 20-004.
2 See here for a chart summarizing the expiration timelines for various federal flexibilities concerning Medicaid and CHIP. This chart was developed with support from the State Health and Value Strategies (SHVS) program, a grantee of the Robert Wood Johnson Foundation.
3 The periodic in-person requirement that is currently being waived until the end of 2024 requires that providers conduct an initial in-person visit with patients at least once within the six months prior to initiating the delivery of tele-behavioral health services, and then once every 12 months thereafter. This requirement does not apply to the treatment of a diagnosed substance use disorder or co-occurring mental health disorder.