Genetic Tests

New Guidelines Advise Against Using Polygenetic Risk Scores for Routine Patient Management

New guidelines from the National Comprehensive Cancer Network (NCCN) advise against using polygenetic risk scores for routine patient management and update previous recommendations for assessing … [Read more...]

Testing Strategy

COVID-19 Retesting Should Be Pushed Back to 4 Weeks to Give Virus Ample Time to Shed

How long does it take a person infected with SARS-CoV-2 to finish shedding the virus? Coming up with the answer to this question to make scientifically sound decisions about not only the clinical … [Read more...]

Top of the News

CDC Withdraws Recommendation of Testing for Asymptomatic Individuals After Close Exposure to COVID-19

The U.S. Centers for Disease Control and Prevention (CDC) raised eyebrows on Aug. 28 when it revised its COVID-19 testing guidance to suggest that testing is not necessarily a must for asymptomatic … [Read more...]

Emerging Tests

New Initiative Seeks to Standardize SARS-CoV-2 Antibody Tests

When the pandemic began, antibody testing was looked to as the kind of ace in the hole that would not only resolve the COVID-19 testing shortage fast and for good but also pave the way for society to … [Read more...]

COVID-19

New Study Shows Saliva-Based SARS-CoV-2 Test to Be at Least as Accurate as Swab Tests

Saliva-based tests could go a long way in relieving the supplies shortages that have hampered COVID-19 testing efforts. The question, though, is whether saliva samples yield results as accurate as … [Read more...]

Emerging Tests

COVID-19 Antigen Tests Are Ready for Mass Utilization but Antigen Test Reporting Is Not

It will take something on the order of 200 million COVID-19 screening tests per month, as opposed to the 25 million being performed currently, to safely reopen the U.S., estimates a new report from … [Read more...]

OIG Findings

OIG Reports that 2018 Medicare Part B Lab Test Spending Increased Despite PAMA Cuts

It wasn’t supposed to happen like this. The expectation was that the new PAMA market-based pricing system was going to save Medicare 10 percent or more on lab test reimbursements. But it hasn’t … [Read more...]

Whistleblowers

California Case Shows Why Paying Specimen Collection Fees of Any Amount Are a Liability Risk

Paying physicians fees to collect and process patient samples for testing is a dicey proposition because it exposes labs to suspicion under the Stark and Anti-Kickback Statute laws. Such arrangements … [Read more...]

Public Health

U.S. Needs 200 Million COVID-19 Screening Tests Per Month to Reopen Safely, Says New Report

How many COVID-19 screening tests per month will it take for the U.S. to reopen safely? One new report estimates the number as around 200 million, which is far below the 25 million tests currently … [Read more...]

Technology

CMS Proposes Clarified Medicare Coverage “Reasonable and Necessary” Criteria for Breakthrough Devices

On Sept. 1, CMS proposed a new rule that would, among other things, shed some light on an issue that has been a perennial compliance and reimbursement stumbling block for developers of new lab tests: … [Read more...]


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