Not Ready for the End Game — Why Ending Federal Covid-19 Emergency Declarations Will Harm Access to Care

Increasing demands that President Joe Biden “end the emergency” reflect political symbolism and understandable longing for normal life. But responding literally, by abruptly terminating federal emergency declarations, will backfire. Doing so will not eliminate the mask, vaccination, and quarantine requirements some Americans oppose — many of which are being discontinued anyway. Moreover, rushed terminations of federal emergency declarations will eliminate regulatory flexibility and financial supports for patients, providers, and the health care system.

US Federal Emergency Declarations in Response to Covid-19.

The response to Covid-19 does not hinge on a single emergency declaration. Overlapping federal, state, and local declarations have triggered executive emergency powers to spend money and issue, suspend, and alter regulations. Most state and local governments have now terminated the declarations that allowed governors and mayors to order travel and business restrictions and mask and quarantine mandates without legislative action.1 At the federal level, several distinct emergency declarations remain active, but their primary effect is to remove regulatory barriers and address liability concerns that would otherwise impede access to health care and medical countermeasures (see table), not to impose mandates.

Because federal agencies have power to regulate patient safety and the interstate spread of disease even without a declared emergency, rescinding federal declarations will have little effect on federal powers to impose vaccination and mask mandates. The vaccination requirement for health care workers issued by the Centers for Medicare and Medicaid Services (CMS) relies on ordinary authority; it does not depend on an active emergency declaration. Similarly, although the Centers for Disease Control and Prevention (CDC) chose to link the duration of its current order requiring masks on airplanes and other public conveyances to the federal public health emergency (PHE) declaration, the order relies on its general powers to control communicable diseases, and the agency could reissue it even if the PHE declaration ends.

The Trump and Biden administrations have used emergency declarations to remove regulatory barriers and liability concerns and provide enhanced funding. Ending these declarations will threaten the availability of medical countermeasures and access to care.

Covid-19 tests, therapeutics, and vaccines, for example, were first available exclusively under emergency use authorizations (EUAs). The Food and Drug Administration (FDA) has now fully licensed some Covid-19 products for some uses — notably, Comirnaty, the Pfizer–BioNTech vaccine, is fully licensed for persons 16 years of age or older, and Spikevax, the Moderna vaccine, is fully licensed for those 18 years of age or older — but access to most products is limited to the duration of an active EUA declaration. By statute, when an EUA declaration ends, any stocks of a product that has not received full approval must be discarded. Use or study of an EUA product beyond the term of an active EUA declaration is subject to governing regulations investigational products and off-label uses. Since the EUA declaration is distinct from other declarations (such as the PHE or National Emergencies Act determinations), access to countermeasures may continue even if other declarations are terminated. But if “ending the emergency” includes terminating the EUA declaration before manufacturers have obtained full licenses, many of the most effective methods for combating Covid-19 — including most molecular and rapid antigen tests, monoclonal antibody treatments, and some vaccines for some populations — would be at risk.

In addition, many health care and other organizations have developed their own capacity to process Covid-19 tests. To do so, they have related on waivers that relax some requirements of the Clinical Laboratory Improvement Amendments, which depend on the PHE declaration.

Moreover, the health and human services (HHS) secretary issued several waivers, tied to the PHE declaration, extending telehealth services and announced that the department would not enforce requirements that a provider–patient relationship be established before a telehealth visit occurs. Waivers also allow Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) beneficiaries to receive care anywhere in the country (not just in areas with health care shortages) and from home, permit additional providers (eg, physician assistants and nurse practitioners) to provide telehealth services, and enable expansion of medical practice across state lines. CMS began to cover more than 100 new telemedicine services (at in-person reimbursement rates) and loosened rules (eg, allowing some audio-only care, such as care provided by telephone). Although HHS has made a few permanent waivers, most will end when the PHE declaration does.

Other telehealth waivers apply to care received even outside federal insurance programs. For example, waivers allow licensed providers to prescribe controlled substances in televisits. In addition, the HHS Office for Civil Rights announced it wouldn’t impose penalties for violations of certain privacy rules during the PHE declaration. For example, it allowed providers to communicate with patients over FaceTime or Zoom, and it eased restrictions to facilitate scheduling of vaccination appointments and communication between providers and business associates such as billing firms.

Medicaid enrollment, for its part, has expanded dramatically during the pandemic, partly because the Families First Coronavirus Response Act increased the federal share of Medicaid costs and requires states to ensure continuous coverage during the federal PHE. An abrupt PHE termination would jeopardize this critical support for approximately 15 million patients and their providers.2 States have halted eligibility redeterminations, creating massive backlogs, which means that many beneficiaries will have difficulty reenrolling when the declaration ends and redeterminations resume. At the same time, Medicaid and CHIP beneficiaries will lose guaranteed access, and access without cost sharing, to monoclonal antibodies. CMS is preparing for this inevitable transition, but it will take time to implement additional financial support and guidance to minimize disruption for patients, providers, and states. In time, Congress may even make some temporary Medicaid enhancements permanent. Rushing this process in response to political pressure to end the emergency puts essential services at risk.

To encourage the development and use of medical countermeasures during an emergency, Congress created a mechanism for HHS to shield manufacturers and health care providers from — and compensate injured patients for — some tort claims under the federal Public Readiness and Emergency Preparedness (PREP) Act declaration (see table). Once the HHS secretary’s PREP Act declaration for Covid-19 is terminated, ordinary state tort liability laws and the remaining patchwork of state liability shields will apply. In addition to the measures detailed above, blanket waivers tied to the PHE and National Emergencies Act declarations ease other regulatory burdens and reporting requirements and delay deadlines throughout the health care sector and beyond.2

Restrictions and mandates implemented through emergency executive actions can undermine democratic processes and civil liberties. Emergencies are therefore typically declared only for widespread, severe, time-limited, and extraordinary circumstances.3 But not all emergencies are the same. Some, such as hurricanes, arrive, do damage, and leave quickly. But some do not. Covid-19 has come in a slow series of destructive waves. All indications are that it will eventually become endemic, and officials will need to mitigate its harms using nonemergency powers.

But the end of the Covid-19 emergency must be designed for Covid-19, not for a hurricane and not in response to public fatigue. Untangling emergency measures sensibly (as the FDA is doing, for instance, by seeking public comment on transition plans4) and keeping the systems that have worked well (eg, some forms of telemedicine and expedited licensing processes) require careful deliberation and time.

When protesters call for an end to the Covid-19 emergency, they’re asking for a return to normalcy. Responding literally, as the Senate recently did in voting to terminate the declaration under the National Emergencies Act, won’t change the controversial requirements that drive opposition but will disrupt care and waste the opportunity for permanent implementation of the new systems that have proved successful.

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