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How Laboratories Are Developing New Coronavirus Diagnostic Tests at Record Speed
The criticism leveled at the Food and Drug Administration (FDA) over the lack of diagnostic tests for COVID-19 in the U.S. belies the unprecedented speed with which new coronavirus tests are reaching the market. Admittedly, the agency was slow out of the gate, waiting until early February to put a coronavirus diagnostics strategy into action. But in the roughly six weeks since then, progress has been unprecedented. Here is a look at the FDA’s regulatory response and where things stand right now. The Historical Context This is the fifth time the U.S. has declared a public health emergency emergency for an infectious disease. The previous emergencies were for H7N9 influenza, Middle East Respiratory Syndrome (MERS), Ebola, EV-D68 and Zika virus. In each case, the FDA has relied on its EUA… . . . read more
G2 Blog
Coronavirus pushing rapid changes in employer law
By Mike O’Brien bio Employer law is rapidly changing amid the coronavirus pandemic. For one thing, Congress has passed another coronavirus related law. The United States Department of Labor (DOL) has provided some helpful guidance and answered a number of questions about the recent expansion of the Family and Medical Leave Act (FMLA) and about the new paid sick leave law, see: DOL FFCRA Q&A. Here are updates: PAID LEAVE UNDER THE EMERGENCY PAID SICK LEAVE ACT (EPSLA): Employees of covered employers (private employers below 500 employees and certain public employers) are eligible for up to two weeks (80 hours) of paid sick leave for certain COVID-19 related reasons. If leave is because he/she is quarantined (by government order or a health care provider), and/or experiencing COVID-19 symptoms and seeking medical… . . . read more
USPSTF Recommends Hepatitis C Virus Infection Screening for All Adults
In response to a spike in hepatitis C virus (HCV) infection cases among young adults, the U.S. Preventive Services Task Force (USPSTF) revised its guidance and is now recommending that all adults, not just older ones get HCV screening. HCV Testing Trends The last time the USPSTF issued HCV screening guidance was back in 2013 when adults born between 1945 and 1965 accounted for an estimated three-fourths of HCV infections. Accordingly, the guidance recommended screening only for adults in that high-risk group. However, the incidence of HCV infection has grown roughly 3.8-fold between 2010 and 2017. Growth in the infection rate has particularly affected younger people, especially intravenous drug users in the age range of 20 to 39. Other the that have been hit hard include American Indian/Alaskan Native and… . . . read more
FDA Finalizes CLIA Waiver Guidance for Approval of New In Vitro Diagnostic Devices
On Feb. 25, the FDA issued a pair of final guidances to help manufacturers seeking clearance for new in vitro diagnostic devices. Here is a summary of the key points from each guidance. CLIA Waivers The first guidance document, “Recommendations for CLIA Waiver Applications for Manufacturers of In Vitro Diagnostic Devices,” explains how sponsors can demonstrate accuracy, i.e., “insignificant risk of erroneous result,” of in vitro diagnostic tests for purposes of obtaining a CLIA waiver. Among other things, it recommends that sponsors use a two-tier approach to demonstrate that their device is robust and has appropriate and effective risk control measures to ensure insignificant risk of an erroneous result: Tier 1: Risk Analysis and Flex Studies. Sponsors should conduct a systematic and comprehensive risk analysis identifying all potential sources of error, including… . . . read more
Billing & Coding: CMS Sets Rules for Medicare Coronavirus Testing Reimbursement with Private Payors Expected to Follow Suit
Good news for labs that are testing Medicare patients for the SARS-CoV-2 virus that causes coronavirus using the Centers for Disease Control and Prevention (CDC) 2019 Real Time RT-PCR Diagnostic Test Panel or the other commercial assays that have recently received Emergency Use Authorization (EUA) from the FDA. Instead, you can use the new Healthcare Common Procedure Coding System (HCPCS) codes that CMS created for labs and other providers for use in billing the brand new tests: HCPCS code U0001 for the CDC test, which CMS announced will be reimbursed at between $35.91 or $35.92 per test; and HCPCS code U0002 for other SARS-CoV-2 virus assays that have received EUA from the FDA, e.g., from Roche and Thermo Fisher Scientific, which will be reimbursed at between $51.31 and $51.33 per… . . . read more
Reimbursement: Congress Calls on Insurers to Cover Coronavirus Testing without Charging Patients
As labs scramble to come up with a coronavirus detection assay and CMS creates a billing and coding regimen, Congress is working to ensure that private payors provide coverage of SARS-CoV-2 testing. On March 6, the U.S. House of Representatives passed a bill requiring insurers to cover all testing without passing costs on to patients. The Bill The coronavirus provisions are part of a larger appropriations bill called the Families First Coronavirus Response Act (HR 6201). Among other things, it instructs insurers that offer group and individual health plans to cover SARS-CoV-2 diagnostics with Emergency Use Authorization (EUA) from the FDA. HR 6201 also calls on insurers to waive deductibles, copayments and coinsurance for patients and refrain from following their usual prior authorization and other utilization management requirements for such… . . . read more