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 CMS Administrator Outlines New Point-of-Care Testing Program

In a call with long term care providers late on Wednesday, Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma offered some details on the agency’s new program to ship point-of-care COVID-19 testing equipment to some 2,000 skilled nursing center facilities starting next week to certain virus “hot spots.”

The CMS chief told providers the agency is working around the clock to get the first wave of testing equipment out to facilities, but it will “take some time” to accomplish the goals of giving facilities the ability to test residents and staff onsite. When the effort was first unveiled on Tuesday, CMS and Health & Human Services Department officials said all of the more than 15,000 skilled nursing facilities in the nation would eventually get the point-of-care testing devices.

In the Wednesday conference call, Verma led off the dialogue by thanking the provider community and its advocates at the American Health Care Association/National Center for Assisted Living (AHCA/NCAL).

“I wanted to thank all of you. I really appreciate the partnership that we’ve had with you over the last few months around the coronavirus. And I particularly want to thank Mark Parkinson [AHCA/NCAL president and chief executive officer] who’s been a terrific partner. He’s always been available. We’ve had many conversations and just really appreciate the support through all of this,” she said.

Verma said the agency has gained insight on the barriers providers are facing in the COVID-19 fight, notably in getting residents and staff tested in a timely manner, if at all.

“We heard you were facing significant challenges with turnaround times and being told by labs that they couldn’t support the testing or need for testing every week of your nursing home workers,” she said. “So, we know this has been a difficult time as you have tried to abide by the CMS recommendations.”

On the point-of-care testing program, Verma said the initial focus for delivering the devices will be in places where the spread of the virus is especially active, like nursing facilities in Florida, Texas, and Arizona. The ramp-up will continue through the summer, CMS said, with many more point-of-care testing devices available to nursing centers by September and October.

“We’ve also been using the data that you all have been turning in to the CDC [Centers for Disease Control and Prevention]… And from that, we’ve been able to put together a list of nursing homes not only in designated hot spots, but those of you who are seeing three or four cases. So, we’ve come up with a list. We’ll be prioritizing those nursing homes here in the next week or so.”

Verma said the testing effort is going to take time to implement and noted that CMS also wants to encourage providers to do testing every week before and after the machines are in place.

“We know that there are areas in the country that are having significant spread, and when we see significant community spread, the chances of it coming to nursing homes are obviously high, and screening your health care workers and testing your health care workers is so critical to ensuring that your nursing home is safe,” she said.

In addition to testing issues, Verma said the agency has heard from providers on when facilities can allow visitors. She said in response to timing concerns, “What we’re hoping is that when you get these tests and you can see there’s no spread in the nursing home for a couple of weeks, then that is also something that you could use those point-of-care tests for, you can use those for visitors that are coming in to the nursing home.”

On other matters related to the point-of-care testing machines, CMS officials said they would provide training in person or over the phone, and any such visit would not be a survey and at no cost. “Also, what we are doing over the next few weeks is we’re announcing a sort of a national training for infection control around coronavirus,” Verma said. “We’ll provide more details in the coming days.”

On costs, CMS officials said they understand that when providers have to use central labs, each virus test can range from $100 to $150 per test to evaluate, prompting the agency to work on the point-of-care testing, where costs range around $25 per coronavirus test.

The agency said the technology it plans to use for the point-of-care tests come from two companies, the first one Quidel and the second is the BD Veritor system. Both of these are point-of-care antigen tests that don’t amplify DNA.

They are not a sophisticated test, but they’re widely used, CMS said. Each of the devices cost between $25,000 and $30,000. “This is how you get your flu diagnosed and strep diagnosed. You can do 15 to 20 per hour if you need to do that many with the system. It’s immediately available to you, obviously, with the result there within the hour,” said a CMS official. “And, secondly, as opposed to $100 or $150, you can buy the test that goes in the system at under $25.”

CMS said this would allow nursing centers kill two birds with one stone by allowing facilities to have immediate testing capability and lower costs.

When asked about the accuracy of the point-of-care tests, Verma said the tests are slightly less sensitive than lab tests, with the agency envisioning accuracy at 85 percent to 90 percent versus the 95 percent to 98 percent seen with lab tests.

The accuracy issue is really about false negatives versus false positives. CMS said if someone tests positive with the point-of-care device, it’s positive. However, if someone gets a negative in a high-risk environment like a nursing facility, providers need to take it as a presumptive negative and repeat that with a laboratory test. But for normal surveillance screening, the machines work really well, CMS said.

Verma said the Medicare program doesn’t pay for surveillance tests. “But if the patient has a positive test with one of these point-of-care tests, and you wanted to do that follow-up testing, then we would reimburse for that, and that can be done at the laboratory and fully reimbursed,” she said. “I’m repeating myself; this will save lives.”

On the question of what the testing devices look like, CMS said they weigh only around a pound and are table-top machines with no hood required.

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