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The slow roll-out of testing for the coronavirus has prompted a more hospitals to develop their own diagnostic capabilities, which they say offers them the best chance to mitigate the impact of the outbreak.
Delays in widespread testing began several weeks ago when the first kits developed by the Centers for Disease Control and Prevention were found to have a faulty compound that caused inaccurate results.
That's led several health systems including Stanford Medicine and the Cleveland Clinic, to mobilize.
"When you have an infectious agent like this that's so pervasive and so highly transmissible, you need to do a lot of testing and do it rapidly and you have to be able to act on the information," said Robert Garrett, CEO of Hackensack Meridian Health, based in N.J., a state that has 33 cases of COVID-19. "If you have a process where everything needs to be distributed through a central group you can't possible keep up with the number of infections."
This week, Meridian Health announced it started testing for COVID-19 and processing lab results from within their own facilities, eliminating the need for test samples to be sent to outside laboratories.
Garrett said the new test will reduce the amount of time it takes to confirm a test from two days to four hours.
Dr. David Perlin, the chief scientific officer and senior vice president for Meridian Health's Center for Discovery and Innovation, said they began developing a test in January. That involved combining elements of the diagnostic produced by the CDC with the test adopted by the World Health Organization.
One issue that led to the delays in developing the test was getting live virus materials needed to validate the tests for FDA approval, which Perlin said they received just last week.
Now Perlin said the health system will be able to test up to 24 patients every eight hours, with the possibility of testing more as more skilled personnel are assigned to perform the tests.
"We're preparing that we may need to ramp up these test numbers," Perlin said.
This week, New York-based Northwell Health also announced it began testing for coronavirus and that it would shorten the time it takes to receive results from 24 hours to three hours. With an investment of $2 million for lab testing and supplies, Northwell is expected to be able to test thousands of patients a day.
Brian Long, CEO of Memorial Healthcare, a 161-bed not-for-profit facility located in central Michigan, said his system has been tracking their response to the outbreak over the past two weeks. He felt hindered by results that took four days to return. Long said Memorial can now get tests back in 30 hours. But as Michigan's cases climb—12 as of deadline—Long worries about capacity to care for and isolate potential patients.
"The quicker that we can confirm the absence of a viral spread then that allows us to continue to have greater capacity as far as staff and providers," Long said.
Memorial has decided to invest what Long said was in the 'low six figures' to purchase equipment needed for in-house testing. They expect to be able to test in about three weeks and when they're up and running to perform about 100 tests a day with results back in about four hours.
Aside from a faster turnaround, Long said conducting their own testing allows them to broaden the scope of who is eligible for testing. Right now, patients must meet certain criteria. That includes having symptoms as well as a history of contact with someone who might have recently traveled to a country that has a high infection rate.
"Testing does not prevent the outbreak, but it does help us do a better job in understanding where the risk is and how we can better respond to that risk," Long said.
Neither Garrett nor Long would say how much it would cost them to conduct their own testing, or whether they could get reimbursed either through private plans or public payers.
Last week, the CMS said that labs performing tests developed by the CDC can bill under code U0001. On Thursday, the agency said that those tests will be reimbursed at $35.91 or $35.92 per test. Labs can begin billing for the tests in April for services occurring after Feb. 4, 2020.
Meanwhile, labs using non-CDC tests can bill for the tests using CPT code U0002, and will be reimbursed at between $51.31 and $51.33 per test.
