Laboratory News Brief - March 2021

March 16, 2021 By: Quadax


Keeping you in the know on the constantly changing world of medical billing and reimbursement, Quadax compiles industry news and articles covering important revenue cycle topics impacting the lab industry. 

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Coronavirus (COVID-19)


COVID-19 Testing Supply Shortages Disrupt 45% of Laboratories, CAP Survey Shows
College of American Pathologists

A CAP survey of board-certified pathologists nationwide showed 45% of laboratories testing for COVID-19 have difficulties obtaining the testing supplies they need. While this represents an improvement since last summer, shortages still represent a substantial burden on those laboratories diagnosing coronavirus disease and require national attention to mitigate disruptions.
[Read more]

Lab Advisory: FDA Issues New Guidance for Evaluating Impact of Viral Mutations on COVID-19 Tests

The U.S. Food and Drug Administration (FDA) recently issued new guidance for test developers. “Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests” provides information on evaluating the potential impact of viral genetic mutations, which may be the basis of viral variants, on COVID-19 tests.
[Read more]

FDA grants first EUA to at-home OTC molecular test for


The FDA has authorized the first over-the-counter, at-home molecular test for COVID-19. Cue Health received the emergency authorization for the 20-minute diagnostic for use in symptomatic and asymptomatic individuals, ages two and older.
[Read more]

CMS moves to stop COVID-19 testing denials, cost sharing in private plans

CMS has issued guidance to stop private group health plans from denying COVID-19 testing through the use of medical screening criteria for asymptomatic individuals with insurance coverage.
[Read more] 

ACLA urges Biden to fund uninsured COVID-19 testing,
close coverage loopholes


A trade group representing laboratories has asked President Joe Biden to make more money available to test uninsured people for COVID-19. 
[Read more]

COVID-19 Took Disease Tests Out of the Lab — And May Keep Them There
The Verge

Before the pandemic, small companies and academic research labs were working on speeding up tests that could diagnose someone’s viral infection by detecting a virus’s genetic material in a swab from their nose or throat. Most of this kind of testing, known as molecular testing, still had to be done in a lab. Yet, experts long predicted that at-home testing could be the future, and the pandemic shortened the timeline to get there.
[Read more]





Exploring the Intersection of Genomic Data and AI in Healthcare

While artificial intelligence in healthcare has the potential to gain actionable insights from genomic data, longstanding challenges could hamper efforts to achieve precision medicine.
[Read more]

Icon - Financial Obligations













CAP Partners with AMA to Stop Medicare Budgetary Cuts to Physicians
College of American Pathologists

At the American Medical Association (AMA) National Advocacy Conference in February, physicians asked federal legislators to relieve the financial burdens of the COVID-19 pandemic by stopping Medicare sequester cuts scheduled to go into effect April 1. The CAP supports the AMA in these efforts as pathologists faced financial hardships during the pandemic.
[Read more]

April 2021 Update of the Hospital Outpatient Prospective
Payment System (OPPS)


This MLN Matters article is for hospitals billing Medicare Administrative Contractors (MACs) for hospital outpatient services they provide to Medicare patients.
[Read more]



Molecular Diagnostics

Technique Brings Study of Molecular Configuration into the Microscopic Domain
Laboratory Equipment

Researchers have developed a spectroscopic microscope to enable optical measurements of molecular conformations and orientations in biological samples. The novel measurement technique allows researchers to image biological samples at the microscopic level more quickly and accurately.
[Read more]


Icon - Denials




Ohio Pathologists, CAP Seek Revision to Out-of-Network Reimbursement
College of American Pathologists

The Ohio Society of Pathologists (OSP) and the CAP have asked the Ohio State Medical Association (OSMA) House to seek revisions to the payment for out-of-network services and adopt a specific policy requiring health plan network adequacy hospital-based physicians by specialty.
[Read more]

UnitedHealthcare Deadline Flexibility for Designated Provider Program
College of American Pathologists

The CAP followed up with UnitedHealthcare leaders to discuss the insurer’s upcoming plan changes and the newly-announced Designated Diagnostic Provider laboratory program. While the February 28 deadline for laboratories to submit a quality questionnaire passed, UHC officials confirmed to the CAP that they would be flexible on that deadline.
[Read more]

Hospital Laboratories Take a Stand Against Controversial UnitedHealthcare Outpatient Reimbursement Policy
G2 Intelligence

A controversial new UHC policy that would require laboratories to meet the standards of its homegrown provider care quality and efficiency program to qualify for reimbursement has hospitals pushing back against the policy and asking the federal government to intervene in the dispute.
[Read more]


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