Federal agencies loosen testing, treatment regulations to help fight coronavirus

New COVID-19 testing by Abbott Laboratories gives results within a matter of minutes. Photo courtesy of ThisIsEngineering
By HARRIET RAMOS
@HarrietRamosETC

Federal agencies are ramping up their response to the COVID-19 crisis by expediting approval for new testing procedures and relaxing regulations to give health care providers more flexibility in treating patients.

At Monday’s White House press briefing, President Donald Trump unveiled a diagnostic test developed by Abbott Laboratories that can show a positive result for COVID-19 in as little as five minutes. Food and Drug Administration Commissioner Stephen Hahn said the FDA approved the test in a matter of weeks when the process normally would have taken months.

“We’ve had a substantial addition to testing with the authorization of point-of-care tests, especially the Abbott point-of-care test,” Hahn said.

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The quick results of this type of testing allow the patient to get the diagnosis at the place of treatment, hence the name point-of-care. Hahn compared it to the test for flu or strep throat that is performed in a doctor’s office in a matter of minutes.

As of March 31, a total of 187,919 people in the United States have been infected with the coronavirus according to Johns Hopkins University. Of those, 3,873 have died and 6,963 have recovered. There are 631 confirmed cases in Dallas County alone, with 13 deaths.

Health officials are hoping that more rapid and accessible testing will improve the rate of recovery from COVID-19.
Secretary of Health and Human Services Alex Azar said as of Monday, there were 20 different emergency testing options available.

“With the FDA responding to requests for authorization typically within 24 hours, the number of options is growing nearly every day,” Azar said.

[READ MORE: Coronavirus timeline]

Besides testing equipment, other private companies have gotten on board with making masks and other personal protective equipment for medical personnel who work with COVID-19 patients. Honeywell is opening two new manufacturing facilities to produce N95 masks, and Jockey is starting production of level 3 isolation gowns.

“I can tell you that more help is on the way,” said Honeywell CEO Darius Adamczyk.
The Center for Medicare and Medicaid Services is also waiving a number of its regulations to help hospitals and health care workers respond more efficiently to the crisis.

“We are engaged in a war against an invisible enemy,” CMS administrator Seema Verma said. “In wartime, the assumptions of peacetime must be re-visited and adjusted to meet the demands of the moment. … In a time of crisis, regulations shouldn’t stand in the way of patient care.”

[READ MORE: Interactive COVID-19 dashboard]

The CMS is allowing for “hospitals without walls,” a concept that will allow hospitals to increase their capacity by setting up treatment sites in locations such as gymnasiums and dormitories. Verma said this will allow hospitals to isolate COVID-19 patients and devote their resources to more serious cases. Off-site treatment facilities can be used for patients who do not have COVID-19.

Verma also said the CMC is making changes to the Medicare program to cover the cost of COVID-19 testing at home and in long-term care facilities.

Verma said some of the regulations that stipulate patients must be seen by their doctors face-to-face are being waived in favor of telehealth, the practice of providing health services remotely. This could help protect health care workers from unnecessarily coming in contact with a patient who has tested positive for COVID-19.

“These …will provide a lot of flexibility from regulations that are ill-suited to the unprecedented needs of this emergency,” Verma said. “Doctors, nurses, and other health care professionals will have the flexibility that they need to confront the … coronavirus pandemic.”

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