The Centers for Medicare and Medicaid Services (CMS) recently announced starting January 1, 2021, Medicare will pay $100 to laboratories that complete high throughput COVID-19 diagnostic tests within two calendar days of the specimen being collected. Also effective January 1, 2021, for laboratories that take longer than two days to complete these tests, Medicare will pay $75.
The rapid rollout in March of the federal FFCRA (Families First Coronavirus Response Act) and CARES (Coronavirus Aid, Relief and Economic Security Act) Acts – and specifically section 6001 of the FFCRA, which defines requirements for insurers – has left providers, labs and insurers uncertain, at times, of their respective responsibilities for COVID-19 testing.
 | Coronavirus (COVID-19) |
| COVID-19 Testing, Treatment and Future Outlook (WEBINAR) 360DX This 6/4 webinar will discuss the current status of COVID-19 testing, treatment and other aspects of the current pandemic as they relate to getting this outbreak under control. [Read more] CDC streamlines lab test result reporting by sharing COVID-19 results reported to public health agencies with HHS system AHA To streamline the reporting of COVID-19 lab test results, the Centers for Disease Control and Prevention yesterday encouraged all U.S. hospital laboratories to submit their COVID-19 testing information to their state or local public health department following their normal protocol for reportable conditions. [Read more] | |
| Lack of routine testing puts labs in financial pinch Becker’s Hospital Review Two of the largest diagnostics companies, Quest Diagnostics and LabCorp, have both taken a hard hit to their finances due to a lack of routine testing. [Read more] | |
| COVID-19 Information CAP COVID-19 Resource Center for labs including recent updates and responses to COVID-19 questions. [Read more] | |
| COVID-19 Precipitates Sharp Decline in Cancer Testing, Diagnoses Clinical OMICs Regular screening is down due to reduction in the number of people having medical appointments, and repurposing of lab resources toward providing COVID-19 testing has impacted these labs’ ability to providing oncology testing. [Read more] NIH Launches $1.5B Rapid COVID-19 Testing Technology Challenge Clinical OMICs A new initiative announced by the National Institutes of Health, backed by a $1.5 billion investment from federal stimulus funding, aims to speed innovation, development, and commercialization of COVID-19 testing technologies. [Read more] | |
| Quality Issues Your Clinical Laboratory Should Know Before You Buy or Select COVID-19 Serology Tests (WEBINAR) Dark Daily Dark Daily is offering this FREE webinar on 5/21 in support of clinical laboratory professionals and pathologists. [Read more] | |
| With So Many New COVID-19 Serology Tests Obtaining EUAs from the FDA, How Can Clinical Laboratories Identify Tests That Should Perform Reliably? (ADDED 5/20) Dark Daily As federal and state officials ease many regulatory requirements to speed new COVID-19 serology tests to market with minimum data about performance, labs are left with important questions to answer on their own. [Read more] | |
| Policy for Coronavirus Disease – 2019 Tests During the Public Health Emergency (Revised) FDAImmediately in Effect Guidance for Clinical Laboratories: FDA is issuing this guidance to provide a policy to help accelerate the availability of novel coronavirus (COVID-19) tests developed by laboratories and commercial manufacturers for the duration of the public health emergency. [Read more] Labs push back on WH testing claims citing lack of critical supplies The HillAcademic medical labs pushed back Tuesday on the Trump administration’s assertion that they are underutilizing COVID-19 testing equipment that could help increase the country’s diagnostic testing capacity. [Read more] | |
 | Molecular DiagnosticsNew Method for RNA-Seq Helps Unravel Data from a Mixture of People Clinical OMICs The Souporcell technique could help study how genetic variants in different people affect which genes are expressed during infection or response to drugs. [Read more] |
 | Payer News |
| Health Insurance Providers Respond to Coronavirus (COVID-19) AHIP List of health insurance providers activating emergency plans to ensure that Americans have access to the prevention, testing, and treatment needed. [Read more] COVID-19: Modified Ordering Requirements for Laboratory Billing CMS MLN Connects (5/7/2020 Issue) During the COVID-19 Public Health Emergency, CMS is relaxing billing requirements for laboratory tests required for a COVID-19 diagnosis. [Read more] Cost Share Covered for COVID-19 Antibody Testing UnitedHealthcare UnitedHealthcare will cover FDA-authorized COVID-19 antibody tests ordered by a physician or appropriately licensed health care professional without cost sharing (copayment, co-insurance or deductible). [Read more] |
| | Coronavirus (COVID-19) |
| Breaking News on Novel Coronavirus Testing 360DX Breaking news on coronavirus testing, with real-time reporting on assays to detect the SARS-CoV2 coronavirus, which causes COVID-19. [Read more] AACC Asks Congress to Wait on LDT Regulation During Coronavirus Outbreak AACC AACC called on lawmakers to pause consideration of a bill that would expand FDA regulation of laboratory-developed tests until the full effects of the virus on the healthcare system can be evaluated. [Read more] | |
| Biodesix Begins Coronavirus COVID-19 Testing Biodesix Biodesix, Inc., a leading diagnostic company in lung disease, announced that it began SARS-CoV-2 Droplet Digital PCR (ddPCR) testing for the virus that causes COVID-19 and will immediately submit for Emergency Use Authorization from the Food and Drug Administration. [Read more] | |
| COVID-19 Information CAP COVID-19 Resource Center for labs including recent updates and responses to COVID-19 questions. [Read more] | |
| COVID-19: A Catalyst For Innovation In Clinical Research? Clinical Research News The novel coronavirus (COVID-19) has presented numerous challenges for clinical research. While some trials for a COVID-19 vaccine have already begun, it will take time before any progress is made for a publicly available drug. And in the meantime, clinical trials not dedicated to the pandemic are struggling to remain operational. [Read more] | |
| What Hospital and Health System Labs Need to Know About Operational Support and Logistics During the COVID-19 Outbreak Dark Daily Dark Daily is offering this FREE 60-minute webinar in support of clinical laboratory professionals and pathologists. [Read more] | |
| Diagnostic Test Kits, Commercial Labs Granted Emergency Use Authorization In Wake Of COVID-19 Diagnostics World The diagnostics community has come out in force to address testing issues for the novel coronavirus. As of April 3, 25 test kit manufacturers and commercial laboratories have been issued Emergency Use Authorization from FDA, and many commercial and healthcare system/academic laboratories have notified the FDA that they have validated their own COVID-19 test and have started patient testing. [Read more] Virtual Town Hall Series – Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests FDAOn April 15, 2020, from 12:15 pm – 1:15 pm Eastern Time, the U.S. Food and Drug Administration (FDA) will host a virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2. [Read more] FAQs On FDA Guidance For Clinical Trials During The COVID-19 Pandemic IMARC ResearchThe FDA added an appendix with frequently asked questions and answers on its previously released guidance document on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic. Here are some key takeaways from the most common questions. [Read more] | |
| JAMA Coronavirus Disease 2019 (COVID-19) JAMA Network Browse the JAMA Network COVID-19 collection, including Q&A’s with NIAID’s Anthony Fauci, an interactive map of the outbreak courtesy of The Johns Hopkins Center for Systems Science and Engineering, and past publications on vaccine development, infection control, and public health preparedness. [Read more] | |
| FDA announces availability of reference sequence data for SARS-CoV-2 Medical Laboratory Observer The Food and Drug Administration—in collaboration with the CDC, BEI Resources, NCBI and NIH— have developed quality-controlled reference sequence data for the SARS-CoV-2 reference strain for the United States. [Read more] | |
| GenomicsCancers’ Complexities, Commonalities Detailed in Extensive Genomic Analysis AACC A massive undertaking involving more than 1,300 scientists from 37 countries reported in 23 papers shows the results of analyzing 47 million genetic changes in 2,600 genomes of 38 different tumor types. The Pan-Cancer Analysis of Whole Genomes presented what the researchers called “the most comprehensive study of whole cancer genomes to date.” [Read more] |
| | Payer |
| Blue Shield of California is offering providers up to $200 million during COVID-19 crisis Healthcare Fiance The nonprofit insurer is working with two financial-services partners to provide financing guarantees, advance payments and restructuring of contracts. [Read more] UnitedHealth Group Accelerates Nearly $2 Billion in Payments and Support to Health Care Providers to Help with COVID-19 Financial Challenges United HealthcareUnitedHealth Group will accelerate nearly $2 billion in payments and financial support to U.S. hospitals and healthcare providers to help address the significant financial pressure many are facing due to COVID-19. [Read more] | |
 | Industry News |
| Because of the COVID-19 Outbreak, AACC Reschedules Its Annual Conference to December in Chicago and Executive War College Reschedules Its Conference in New Orleans to July Dark DailyTwo major clinical laboratory conferences reschedule: American Association of Clinical Chemistry moves from July to December 13-17 in Chicago and Executive War College moves from April to July 14-15 in New Orleans. [Read more] |
