23 Florida counties are nursing home 'hot spots.' Feds sending testing aid to 85 homes.

Jul. 24--TALLAHASSEE -- COVID-19 cases are rising so dangerously fast at nursing homes in 23 "hot spot" counties of Florida that federal regulators on Friday said they are deploying 85 rapid testing machines to immediately test staff in an effort to staunch the spread of the virus.

The Centers for Medicare & Medicaid Services released its list of 62 counties throughout the nation that it considers "hot spots" and more than a third were in Florida. According to the CMS data site, a county is considered a hot spot if, in the last week, it either reported three or more new cases of COVID-19 in a nursing home, demonstrated inadequate access to testing, had at least one new resident death due to COVID-19 or had at least one new confirmed or suspected COVID-19 case among staff.

The testing is also intended to open the door to the possibility that visitors could return to nursing homes where COVID infections among staff and residents have been kept at bay.

"We want to make sure that there's no COVID inside the nursing home, and then once we see that for two weeks, our recommendation will be to permit visitation and require testing of the visitors," said CMS administrator Seema Verma in a conference call with reporters.

CMS has intensified its focus on Florida as the state had the deadliest week to date among nursing home and other long-term care residents, with more than 250 deaths reported between July 17 and July 23.

As of Friday, July 24, 2,557 residents and staff at long-term care facilities in Florida have died of COVID-19, 46% of all 5,518 deaths in the state.

CMS also announced earlier this week that it will adopt new rules that require staff in nursing homes in counties where the positivity rate is above 5% to be tested at least weekly until the spread of the coronavirus starts slowing. CMS currently only "recommends" that testing occur regularly.

Goal is to deploy 15,000 machines

The goal of the federal program is to deploy 15,000 of the new testing machines to counties, starting with 636 to be shipped this week, and also to be "ratcheting up financial penalties" for homes that violate basic protocols such as hand-washing and mask-wearing, Verma said.

"We're going to be targeting those nursing homes that are in hot spots and that also are experiencing significant case load," she said.

In Florida, the first round of machines will be distributed to 85 nursing homes, including the following counties: 6 in Miami-Dade, 7 in Broward, 1 in Monroe, and 15 in Palm Beach. (See list below.)

The machines are being paid for through a $5 billion CARES Act program. But questions are emerging about whether the program, announced by CMS on Wednesday, is using the best equipment to identify the virus among asymptomatic carriers.

"This new staff testing requirement will enhance efforts to keep the virus from entering and spreading through nursing homes by identifying asymptomatic carriers," CMS said in a press release when it announced the program.

The agency's director of external affairs, Mia Palmieri Heck, said the program will be purchasing antigen tests made by Quidel Corporation and Becton Dickinson (BD). They are a new type of diagnostic test approved by the Food and Drug Administration for rapid detection of the virus that causes COVID-19.

But, Heck said, they may not be effective at catching people who are positive but show no symptoms.

"One of the main advantages of an antigen test is the speed of the test, which can provide results in minutes," Heck said, quoting from the FDA press release on the subject. "However, antigen tests may not detect all active infections, as they do not work the same way as a PCR test."

False-negative results

According to the Food and Drug Administration, there are two types of tests approved for diagnostic testing, the PCR, polymerase chain reaction test, which is a molecular diagnostic test that detects the genetic material from the virus, and the antigen test, which also detects the presence of the virus, but because it is not as sensitive as molecular PCR tests may miss it some of the time.

"This means that positive results from antigen tests are highly accurate, but there is a higher chance of false negatives, so negative results do not rule out infection," the FDA release said. "With this in mind, negative results from an antigen test may need to be confirmed with a PCR test prior to making treatment decisions or to prevent the possible spread of the virus due to a false negative."

The antigen test also can be produced at a lower cost than PCR tests and federal health officials hope that once several companies enter the market to produce the rapid testing machines they will become abundantly available at lower costs, and institutions, from nursing homes to schools, can identify infection rates closer to real time.

Nursing home industry leaders have been asking for a rapid testing machine for months, as the outbreak has taken the lives of an estimated 38,000 residents of their facilities across the country.

In Florida, more than 7,669 staff and residents at nursing homes and assisted living facilities have been infected with COVID-19 in the month of July, a 148% rise, and public health experts and regulators say it is primarily caused by vendors and staff who unwittingly bring it into homes that are on lockdown.

Earlier this week, members of LeadingAge, the trade association for non-profit nursing homes called the crisis in Florida a "category five emergency" and demanded that Congress take action to bring rapid testing to their facilities.

The program will also pay for technology so residents can connect with their families if they are not able to visit.

However, Verma made it clear that it may be weeks or months before many homes see either a rule requiring weekly testing or the new testing machines. The mandate requires formal rule-making, and Verma declined to give a timeline for when the testing rule would be issued but suggested it "will come out very shortly."

That brought criticism from advocates who have been calling on federal officials to provide rapid testing machines to better shield vulnerable residents from the virus.

Katie Smith Sloan, president and CEO of non-profit senior care group LeadingAge, called the announcement "a good next step" but asked the federal government to provide a more comprehensive plan for protecting seniors during the ongoing COVID-19 pandemic.

"Perhaps the most important question our members and millions of older adults and their families have: Is this yet another patch in the patchwork federal response we've seen from the administration so far? Or is this announcement a signal that real relief is on its way?" she said in a statement.

"Either CMS doesn't know what they're sending nursing homes or they're deliberately trying to mislead the American people by obfuscating the "rapid testing" terminology or both," said Brian Lee, president of Families for Better Care, an advocacy group working with families of nursing home residents. "Molecular is the golden testing ticket. If it's not molecular rapid testing then we're no closer to healing our nation's nursing homes than we were six months ago."

Other federal help

Earlier this week, CMS deployed a "task force strike team" to 18 facilities in Illinois, Florida, Louisiana, Ohio, Pennsylvania, and Texas to focus on helping them better detect COVID-19 cases quickly, prevent virus transmission, and manage staff.

"The goal was to determine what immediate actions nursing homes needed to take to help reduce the spread and risk of COVID-19 among residents, and to better understand what federal, state, and local resources nursing homes need to ensure the health and safety of their residents," CMS reported in a press release.

The American Health Care Association, which represents for-profit nursing homes, praised the announcement, but its CEO Mark Parkinson urged Congress to include more aid in a future relief package.

"While this funding is a significant step forward, it is equally important for Congress to provide an additional $100 billion for the HHS Provider Relief Fund, which is accessible to all health care providers impacted by COVID-19, and that a sizable portion of the fund be dedicated to helping both nursing homes and assisted living communities to cover the enormous costs associated with protecting vulnerable residents and staff from the virus," Parkinson said in a statement.

Mary Ellen Klas can be reached at meklas@miamiherald.com and @MaryEllenKlas

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