WHO Declares Coronavirus Pandemic
- March 13, 2020
The World Health Organization (WHO) declared March 11 the rapidly spreading coronavirus a pandemic, citing a 13-fold increase in the number of cases outside China in the last two weeks.
WHO previously had stopped short of labeling the coronavirus a pandemic, describing it in January as a "public health emergency of international concern" and later labeling the global threat from COVID-19 at the highest level.
"In the days and weeks ahead we expect to see the number of cases, the number of deaths and the number of affected countries climb even higher. WHO has been assessing this outbreak around the clock and we're deeply concerned both by the alarming levels of spread and severity and by the alarming levels of inaction," WHO Director-General Dr. Tedros Adhanom Ghebreyesus said.
Speaking from the Oval Office March 11, President Trump announced a 30-day travel ban from 26 European countries, excluding the United Kingdom. The Department of Homeland Security Acting Secretary Chad F. Wolf later clarified that the ban didn't apply to legal permanent residents and immediate family members of U.S. citizens. Individuals returning from the named European countries will face a mandatory 14-day quarantine, officials said.
During his remarks, President Trump also indicated that health insurance providers would waive copayments for coronavirus-related treatments, though the White House later made clear that the copayments would be waived for coronavirus testing only, not treatments.
At this writing, President Trump reportedly was expected to declare a national emergency under the Stafford Act to free up additional federal resources to combat the coronavirus.
Legislation Expected Soon
Congress last week passed an emergency spending package devoting $8.3 billion in funding for efforts to combat the coronavirus. Meanwhile, House Democrats unveiled March 11 legislation, The Families First Coronavirus Response Act (H.R. 6201), that includes free coronavirus testing, paid emergency sick leave, enhanced unemployment insurance, and increased funding for Medicaid among other measures to help vulnerable populations.
"The Families First Coronavirus Response Act is focused directly on providing support for America's families, who must be our first priority in this emergency. We cannot fight coronavirus effectively unless everyone in our country who needs to be tested knows they can get their test free of charge. We cannot slow the coronavirus outbreak when workers are stuck with the terrible choice between staying home to avoid spreading illness and the paycheck their family can't afford to lose," House Speaker Nancy Pelosi said.
Pelosi reportedly has been in talks with the administration to craft a measure that can win support in the Senate. According to published reports, Pelosi signaled a vote on the measure was likely by Friday.
Agency Guidance
The Centers for Medicare & Medicaid Services (CMS) issued a slew of guidance and additional resources as part of its efforts to respond to the coronavirus outbreak.
In a March 10 memorandum, CMS outlined the flexibilities that Medicare Advantage and Part D plans have to waive cost-sharing for COVID-19 tests and treatments, remove prior authorization requirements, waive prescription refill limits, relax restrictions on home or mail delivery of prescription drugs, and expand access to certain telehealth services.
CMS also provided March 10 more detailed guidance to home health agencies and dialysis facilities developed in part on frequently asked questions the agency has received.
In addition, CMS sent a memo to state survey agencies expanding guidance on personal protective equipment for health care workers. The memo clarifies the application of CMS policies given new Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) guidance expanding the types of facemasks health care workers may use when treating patients with COVID-19 or other respiratory infections.
Citing high demand for respirators, the memo implements recent CDC guidance stating that facemasks that protect from splashes and sprays are an acceptable temporary alternative until demand for respirators lessens.
On March 9, CMS issued guidance on the implications of COVID-19 for hospital compliance with the Emergency Medical Treatment and Labor Act (EMTALA).
The guidance notes that EMTALA requires hospitals with a dedicated emergency department to conduct an appropriate medical screening of all individuals who come to the emergency room, including those suspected of having COVID-19.
For suspected or confirmed cases of COVID-19, hospitals, taking into account current guidance from the CDC and public health officials, must determine whether they have the capability to provide appropriate isolation required for stabilizing treatment or to accept appropriate transfers, according to the guidance. CMS said it will consider public health guidance in effect at the time in the event of any EMTALA complaints involving transfers.
Other Developments
- The Internal Revenue Service issued Notice 2020-15, providing that, until further notice, high deductible health plans (HDHP) will not lose the HDHP designation merely by providing health benefits related to testing and treating COVID-19 without a deductible. "Therefore, an individual covered by the HDHP will not be disqualified from being an eligible individuals . . . who may make tax-favored contributions to a health savings account," the notice said.
- The Department of Health and Human Services Secretary issued March 12 a declaration providing liability immunity to drug and device manufacturers working on COVID-19 medical countermeasures. Immunity does not extend to "willful misconduct." The Secretary issued the declaration pursuant to the Public Readiness and Emergency Preparedness Act (PREP Act), as amended by the Pandemic and All-Hazards Preparedness Reauthorization Act. The liability immunity is effective retroactive to February 4, 2020 through October 1, 2024.
- In a March 12 letter to Vice President Mike Pence, the American Hospital Association (AHA), the American Nurses Association (ANA), and the American Medical Association (AMA) urged President Trump to declare the COVID-19 outbreak a national disaster or emergency. "This step is necessary to provide the Department of Health and Human Services (HHS) Secretary Alex Azar the authority to take critical actions, such as providing Section 1135 waivers, to ensure that health care services and sufficient health care items are available to respond to the COVID-19 outbreak," the letter said. Azar in January declared the outbreak a public health emergency, but the groups said a presidential disaster or emergency disaster would clear the way for additional flexibilities.
- Facing ongoing criticisms about the lack of testing for the coronavirus, the FDA unveiled March 12 new steps to help expedite the availability of testing. First, the agency said it would exercise enforcement discretion and is not objecting to the New York State Department of Health's authorization of certain New York laboratories to begin patient testing after appropriate validation. Second, the FDA granted Emergency Use Authorization for Roche's COVID-19 diagnostic test.
- CMS posted March 13 Frequently Asked Questions (FAQs) on Essential Health Benefits (EHB) for the coronavirus outbreak. The FAQs detail federal rules for health coverage provided through the individual and small group insurance markets that apply to the diagnosis and treatment of COVID-19, including which testing, isolation/quarantine, and vaccination services are generally covered.