Moderate Complexity Test: Page 5

CMS ups Medicare payment for high-throughput COVID-19 lab tests
By LabPulse.com staff writers
Effective April 14 and for the duration of the COVID-19 national emergency, Medicare will now pay laboratories $100 for COVID-19 clinical diagnostic lab tests that make use of high-throughput technologies developed by the private sector, according to CMS. These tests can process more than 200 specimens each day.
April 14, 2020
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AACC responds to reports of bad blood tests for coronavirus
By LabPulse.com staff writers
In a statement on April 14, AACC President Carmen Wiley, PhD, noted that there have been "worrying reports" of a small number of unreputable diagnostic companies taking advantage of the relaxation of U.S. Food and Drug Administration (FDA) rules during the coronavirus pandemic. Initially, the FDA required all entities to secure an emergency use authorization (EUA) on tests for SARS-CoV-2/COVID-19. The restrictions were controversial. But in mid-March the agency relaxed regulations for vendors and also labs developing their own tests to permit marketing without an EUA.
April 13, 2020
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CMS issues guidance on coverage for COVID-19 tests
By LabPulse.com staff writers
The move is an effort to mitigate financial barriers Americans may face to receiving COVID-19 testing and health services, CMS said.
April 12, 2020
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FDA vows action on false claims for coronavirus antibody tests
By LabPulse.com staff writers
Some firms are falsely claiming that their serological tests are FDA-approved or authorized, or falsely claiming that they can diagnose COVID-19, FDA Commissioner Dr. Stephen Hahn explained in a statement.
April 7, 2020
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CMS delivers $34B in accelerated COVID-19 payments
By LabPulse.com staff writers
In less than two weeks, CMS received more than 25,000 requests from healthcare providers and suppliers for accelerated and advance payments. The agency already has approved some 17,000 of those requests in the last week. By comparison, CMS approved slightly more than 100 total requests in the past five years, most of which were due to natural disasters, such as hurricanes.
April 7, 2020
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Co-Diagnostics garners EUA for COVID-19 test
By LabPulse.com staff writers
Clinical laboratories certified under CLIA can now use the test to detect the novel coronavirus that causes the respiratory disease COVID-19. The company said it began offering the product to CLIA labs last month, following the FDA's relaxation of regulations on testing, which paved the way for use prior to an EUA. The test had previously received the CE Mark in Europe.
April 6, 2020
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Waiver allows pathologists to work remotely during pandemic
By LabPulse.com staff writers
Through a waiver, pathologists have regulatory flexibility in terms of where they work, with temporary relief from the CLIA regulations, which require pathologists to perform diagnostic tests at certified facilities.
March 26, 2020
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CDC accelerates effective date of COVID-19 code
By LabPulse.com staff writers
The CDC had originally issued the code U07.1, COVID-19, and said it would take effect with the next update of the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM), scheduled for October 1, 2020.
March 22, 2020
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VITAL Act steps in on regulation of lab-developed tests
By LabPulse.com staff writers
Introduced by Sen. Rand Paul (R-KY), the VITAL Act also proposes ways to modernize CLIA regulations governing LDTs.
March 18, 2020
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FDA gives states, vendors more power in coronavirus fight
By Brian Casey
The FDA has been under heavy pressure to ease its regulations on diagnostics to get more tests into the field for the SARS-CoV-2 coronavirus, which causes the COVID-19 respiratory disease. Clinicians and public health authorities have claimed that not enough tests are available to meet demand, so the agency has made a series of regulatory changes over the last several weeks that relax its oversight.
March 15, 2020
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Quest provides update on COVID-19 testing
By LabPulse.com staff writers
Quest on March 9 announced it had introduced its own laboratory-developed test (LDT) for COVID-19, and the test can be ordered from any healthcare provider in the U.S. The tests are processed at the company's Quest Diagnostics Infectious Disease laboratory in San Juan Capistrano, CA.
March 15, 2020
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FDA grants EUA to Thermo's coronavirus diagnostic test
By Brian Casey
The FDA granted the EUA to Thermo Fisher's TaqPath COVID-19 combo kit, a multiplex real-time reverse transcription polymerase chain reaction (RT-PCR) diagnostic test that can diagnose the SARS-CoV-2 virus, which causes COVID-19.
March 15, 2020
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