Moderate Complexity Test: Page 4

Trump announces new COVID-19 testing requirements for nursing homes
By LabPulse.com staff writers
CMS will begin requiring, and not just recommending, that all nursing homes in states with a 5% positivity rate or greater test all nursing home staff each week. Doing so will enhance efforts to keep the virus from entering and spreading through nursing homes by identifying asymptomatic carriers, CMS said.
July 23, 2020
2020 07 24 20 30 2278 Senior Wheelchair Mask 400
Could COVID-19 end standoff on tests developed in laboratories?
By Bruce Carlson
Labs developing their own tests for a variety of conditions make up a significant part of testing in the U.S. and other countries, according to Kalorama Information, a sister company of LabPulse.com. While there is a $70 billion market for IVD products, commercial tests are not always sufficient for demand. Laboratory-developed tests were controversial before the COVID-19 pandemic, and there were attempts at imposing more scrutiny on them in the U.S., where an enforcement loophole has kept labs relatively unregulated by the U.S. Food and Drug Administration (FDA).
July 16, 2020
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Telemedicine association asks U.S. Congress for permanent reform
By LabPulse.com staff writers
U.S. Congress expanded access to telehealth services during the COVID-19 pandemic by giving the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) the authority to waive restrictions on Medicare telehealth services.
June 30, 2020
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AMA adds new CPT code for COVID-19 antigen tests
By LabPulse.com staff writers
The new code -- 87426 -- is intended for use as the industry standard for reporting and tracking of antigen tests using immunofluorescent or immunochromatographic techniques for the detection of biomolecules produced by the SARS-CoV-2 virus, according to the AMA. The code was approved on June 24 during a special meeting of the CPT Editorial Panel.
June 29, 2020
2020 02 13 19 55 0762 Dollar Sign Green 400
Cue gets FDA clearance for point-of-care coronavirus test
By LabPulse.com staff writers
The Cue Health COVID-19 molecular test detects SARS-CoV-2 nucleic acid from a nasal swab sample. It runs a 25-minute analysis directly at the point of care and delivers the results to the Cue mobile app.
June 14, 2020
2020 03 04 00 35 9478 Smartphone Hands 400
ChromaCode lands clearance for high-definition PCR coronavirus test
By LabPulse.com staff writers
The high-definition kit is designed to increase test throughput and reduce complexity in interpretation. Those who sign agreements with ChromaCode are guaranteed ongoing supplies, according to the company.
June 9, 2020
2020 05 15 21 21 3306 Green Traffic Light 400
Medicare reimbursement could rev up COVID-19 antibody testing
By LabPulse.com staff writers
ACLA President Julie Khani applauded the reimbursement rate, noting that it will allow labs to expand testing capacity. Two Current Procedural Terminology (CPT) codes may be used to bill for tests conducted after April 10 -- 86769 and 86328, CMS explained in a May 19 statement.
May 19, 2020
2020 03 24 20 53 4672 Dollar Sign Golden 400
Quidel clearance signals arrival of rapid antigen tests for coronavirus
By Emily Hayes
Quidel's Sofia 2 SARS antigen point-of-care (POC) test is designed for use with the company's Sofia 2 fluorescent immunoassay analyzer. On May 9, the FDA granted emergency use authorization (EUA) for the test for use by CLIA-certified moderate- and high-complexity labs and facilities that have a CLIA waiver.
May 10, 2020
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FDA policy change may put an end to 'Wild West' of coronavirus antibody tests
By Emily Hayes
The FDA released on May 4 revised guidance on coronavirus tests on an emergency basis, as an update to a policy set in March, which had allowed test developers to market tests through notification of the agency without an EUA.
May 3, 2020
2020 05 04 22 54 5115 Metal Wheel 400
CMS expands coverage of coronavirus testing, includes serology
By LabPulse.com staff writers
April 29, 2020
2020 04 30 21 13 0442 Medicare Puzzle 400
CMS suspends emergency loan program
By LabPulse.com staff writers
The programs provide temporary loans during emergencies to cover claims processing and other expenses. The CMS had expanded them in light of the COVID-19 pandemic and since March 28 paid out $59.6 billion to Part A providers, which include hospitals, and $40.4 billion to Part B suppliers include doctors, nonphysician practitioners, and medical equipment suppliers.
April 26, 2020
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FDA issues COVID-19 digital pathology device guidance
By Kate Madden Yee
The guidance is intended to help industry, clinical laboratories, healthcare facilities, pathologists, and FDA staff boost availability of devices for remote reviewing and reporting of scanned digital pathology slides during the pandemic, the agency said.
April 26, 2020
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