Coronavirus Update – June 17, 2020

Coronavirus Update – June 17, 2020

More than 8 million cases of coronavirus (COVID-19) have been diagnosed worldwide as of Monday evening, including at least 434,000 deaths. Healthcare officials in the United States have reported more than 2.1 million positive COVID-19 patients and more than 114,000 deaths.

Could New Virus Spike Threaten Skilled Facilities?

As many states across the United States begin to ease their COVID-19 quarantine restrictions and crowds gather, a new trend that has seen rising numbers of younger adults testing positive could once again threaten the country’s nursing home residents. “Many of these younger people work in nursing homes; so now these residents are more at risk again,” said Christina Ramsey, RN, MSN, GNP-BC, LNCC, CWS, a gerontological nurse practitioner and legal consultant in the fields of Medicare and nursing.
Recent reports claim that the seven-day average of new cases has increased since May 31 while the average number of daily tests being conducted has declined in Kentucky, Missouri, Oklahoma, South Carolina, South Dakota, and Wyoming, according to data collected by the COVID Tracking Project and the New York Times. In 14 other states, the rate of new cases is said to be increasing faster than the increase in the average number of tests. In 10 states, the seven-day average of the rate at which tests are coming back positive has increased more than two percentage points since the end of May. In 11 other states, the seven-day average for the number of new deaths is up at least five percent since the end of last month.
The Washington Post now offers a tool that allows the user to select a custom time range for the sake of comparing new daily cases, daily reported tests, the percent of positive tests, and the number of deaths per day by state.1

Nursing Home Waiver Tempting Fraudulent Behavior?

As the Centers for Medicare & Medicaid Services announced various waivers related to the care of the country’s elderly Medicare patients during the developing COVID-19 pandemic, concern has surfaced that dishonest behavior related to documentation and reimbursement in healthcare facilities could have resulted. At the very least, the opportunity for unethical practices has been apparent, according to Christina Ramsey, RN, MSN, GNP-BC, LNCC, CWS, a gerontological nurse practitioner and legal consultant in the fields of Medicare and nursing. Specifically, the waiving of the three-day qualifying hospital stay requirement for those residents admitted into skilled nursing care is of particular risk to skewed reporting practices. 

“The waiver itself states that you can waive the three midnight qualifying hospital stay and admit a resident directly into Medicare for reimbursement from any facility or home, if their care relates to COVID-19 and a hospital needs to clear its emergency room beds for other more seriously ill patients,” Ramsey said. “But I’ve heard that some facilities believe they can admit all patients in this fashion through the waiver code because they are unlikely to be audited. You don’t want to be the one who has to answer the questions if there’s concern that your admitted resident does not meet the criteria.” Additionally, deviating from the true scope of the waiver, could put people at increased risk by having them admitted to a facility,” Ramsey said.

Language from the waiver policy includes, in part: “The Social Security Act authorizes skilled care coverage in the absence of a qualifying hospital stay, as long as this action does not increase total program payments and does not alter the nursing facility benefit’s ‘acute care nature”’ (that is, its orientation toward relatively short-term and intensive care).” The requirement is intended for those beneficiaries who are evacuated or transferred as a result of an emergency situation. In this way, beneficiaries who may have been discharged from a hospital early to make room for more seriously ill patients will be eligible for Medicare Part A skilled care benefits. In addition, beneficiaries who had not been in a hospital or a skilled facility prior to being evacuated, but who need skilled care as a result of the emergency, will be eligible for Medicare Part A skilled care coverage without having to meet the three-day qualifying hospital-stay requirement.

Emergency Approval For Antimalarial Drugs Revoked By The FDA

Officials with the Food & Drug Administration (FDA) have withdrawn an emergency use authorization for the drugs hydroxychloroquine and chloroquine, both of which had been previously granted for the treatment of COVID-19. According to an announcement by the FDA on June 15, the medications were unlikely to be effective for COVID-19 and any potential benefits are outweighed by safety risks, which reportedly included cardiac issues. Denise M. Hinton, the FDA’s chief scientist, wrote that the decision was prompted by new information, including clinical trial results, in a letter dated June 15.2

Chloroquine and hydroxychloroquine are both approved by the FDA to treat or prevent malaria. Hydroxychloroquine is also approved to treat autoimmune conditions such as chronic discoid lupus erythematosus, systemic lupus erythematosus in adults, and rheumatoid arthritis. Both drugs have been prescribed for years to help patients with these diseases, and the FDA determined that these drugs are safe and effective when used for these diseases in accordance with their FDA-approved labeling.
“While additional clinical trials continue to evaluate the potential benefit of these drugs in treating or preventing COVID-19, we determined the emergency use authorization was no longer appropriate,” said Patrizia Cavazzoni, MD, acting director of the FDA’s Center for Drug Evaluation. “This action was taken following a rigorous assessment by scientists in our Center for Drug Evaluation and Research. We remain committed to using every tool at our disposal in collaboration with innovators and researchers to provide sick patients timely access to appropriate new therapies. Our decisions will always be based on objective and rigorous evaluation of the scientific data. This will never change.”

References

1. Bump P. Despite trump’s claim, the increase in new coronavirus cases isn’t just a function of testing. Washington Post. 2020. Accessed online: www.washingtonpost.com/politics/2020/06/15/despite-trumps-claim-increase-new-coronavirus-cases-isnt-just-function-testing

2. FDA revokes emergency use authorization for chloroquine and hydroxychloroquine. FDA. 2020. Accessed online: www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-chloroquine-and