End of COVID Emergency Brings Changes for Health Care Providers, Patients

WASHINGTON — Three years after the onset of the COVID-19 pandemic, the public health emergency declared to combat it will come to an end on Thursday, May 11.

Though public health officials say SARS-CoV-2, the virus that causes COVID-19, remains a public health priority, every objective measure suggests it’s time to return to “normal.”

Since the peak of the omicron surge at the end of January 2022, daily COVID-19 cases are down 92%, while COVID-19 hospitalizations are down nearly 80%. 

COVID-related deaths are also down 80% since then, all of this the result of the largest adult vaccination program in U.S. history.

In all, nearly 270 million Americans received at least one shot of a COVID-19 vaccine.

So what will “normal” mean come May 11 and thereafter?

Officials at the Department of Health and Human Services emphasize that the Biden administration’s ongoing response to COVID-19 is not fully dependent on their being a declared health emergency.

Vaccines and treatments will still be widely accessible to those who need them, and the Food and Drug Administration will still be able to issue emergency use authorizations for new COVID-19 tests, vaccines and treatments.

In addition, significant telehealth “flexibilities” will continue to exist for those participating in Medicare or Medicaid.

But some policies and so-called flexibilities will change.

Skilled Nursing Facility Stays

For instance, the Centers for Medicare and Medicaid Services has determined that certain waivers and broad flexibilities given health care providers during the public health emergency are no longer needed and will end.

Many of the hundreds of waivers provided to states, hospitals and nursing homes during the crisis were intended to expand facility capacity and help the nation’s health care system weather the heightened case load created by COVID-19.

Among those that will go away (and bear with us, this gets to sound a little bureaucratic) is the waiver of the Medicare three-day qualifying hospital stay requirement prior to a Medicare-covered skilled nursing facility stay.

What that means is that any Medicare Part A-covered skilled nursing facility stay without a qualifying hospital stay that begins on or prior to May 11 can continue for as long as the beneficiary has Part A SNF benefit days available and so long as the beneficiary continues to require skilled daily care.

After May 11, these stays will require a qualifying hospital stay to qualify for coverage.

All this said, a doctor or other health care provider who is part of an “Accountable Care Organization” may still be able to send patients for a Medicare-covered skilled nursing facility stay even if they have not stayed as an inpatient in a hospital for at least three consecutive days first.

For someone to qualify for this benefit, the doctor or other provider has to decide that skilled nursing facility care is needed and certain other eligibility requirements are met.

Additionally, MA plans may elect to furnish coverage of post-hospital skilled nursing facility care in the absence of the prior qualifying hospital stay as part of their Medicare-covered services.

According to the American Hospital Association, “Accountable Care Organizations” are groups of clinicians, hospitals and other health care providers who come together voluntarily to give coordinated high-quality care to a designated group of patients.

Coverage for COVID-19 Testing

Medicare beneficiaries who are enrolled in Part B will continue to have coverage without cost sharing for laboratory-conducted COVID-19 tests when ordered by a provider, but their current access to free over-the-counter COVID-19 tests will end, consistent with the statute on Medicare payment for OTC tests set by Congress.

The requirement for private insurance companies to cover COVID-19 tests without cost sharing, both for OTC and laboratory tests, will also end. However, coverage may continue if plans choose to continue to include it. 

State Medicaid programs must provide coverage without cost sharing for COVID-19 testing until the last day of the first calendar quarter that begins one year after the last day of the COVID-19 public health emergency. 

In other words, because the COVID-19 public health emergency is ending on May 11, mandatory coverage will end on Sept. 30, 2024, after which coverage may vary by state.

Additionally, depending on supply and resources, the U.S. government may continue to distribute free COVID-19 tests from the Strategic National Stockpile through the United States Postal Service, states, and other community partners.

Reporting of Lab Results and Immunization Data

During the public health emergency, the Department of Health and Human Services had the authority to require lab test reporting for COVID-19. Once the public health emergency ends, HHS will no longer have this authority.

Officials concede this may affect the reporting of negative test results and impact the ability to calculate percent positivity for COVID-19 tests in some jurisdictions.

In response, the Centers for Disease Control and Prevention has been working to sign voluntary Data Use Agreements, encouraging states and jurisdictions to continue sharing vaccine administration data beyond the end of the emergency. 

Hospital data reporting will continue as required by the CMS conditions of participation through April 30, 2024, but officials said reporting may be reduced from the current daily reporting to a lesser frequency.

Detecting Shortages of Critical Devices

During the public health emergency, manufacturers of certain devices used to diagnose and treat COVID-19 have been required to notify the FDA if there is a disruption in the production of the device or if it has been permanently discontinued.

This requirement will end when the public health emergency ends. While FDA will still maintain its authority to detect and address other potential medical product shortages, it is currently seeking congressional authorization to extend the requirement for device manufacturers to notify FDA of significant interruptions and discontinuances of critical devices once the emergency formally ends.

Liability Protections May Be Impacted

Currently, the amended Public Readiness and Emergency Preparedness Act provides liability immunity to manufacturers, distributors, public and private organizations conducting countermeasure programs, and providers for COVID-19 countermeasure activities related to a U.S. government agreement. That coverage will not be affected by the end of the public health emergency.

However, PREP Act liability protections for countermeasure activities that are not related to any U.S. government agreement — for instance, products entirely in the commercial sector or solely a state or local activity — will end unless another federal, state, or local emergency declaration is in place for areas where the countermeasures are administered. 

The Department of Health and Human Services is reviewing whether to continue to provide this coverage going forward.

Dispensing Controlled Substance via Telemedicine

During the public health emergency, the Drug Enforcement Administration and HHS adopted policies to allow DEA-registered practitioners to prescribe controlled substances to patients without an in-person interaction. 

For instance, these policies allowed telehealth care providers to prescribe buprenorphine to treat pain as well as narcotic addiction. 

DEA is planning to initiate rulemaking that would extend these flexibilities under certain circumstances without any gap in care and will provide additional guidance to practitioners soon.

For more on what will and won’t be affected by the end of the COVID public health emergency, click here.

The Centers for Medicare and Medicaid Services has also prepared an FAQ, that can be read here.

Dan can be reached at [email protected] and at https://twitter.com/DanMcCue