In standing aside and allowing test makers to validate and perform COVID-19 laboratory developed tests (LDTs) and not wait for Emergency Use Authorization (EUA), the FDA has actually acknowledged what … [Read more...]
LDTs
Laboratory Developed Tests: The VALID Act is Back
March 18, 2020
With all the attention commanded by the coronavirus crisis, a potentially huge development affecting the future of the lab industry has flown under the radar. What’s at stake is the issue that has … [Read more...]
CLIA: CMS Issues Guidance on How Labs Should Perform Coronavirus Testing
February 27, 2020
On Feb. 6, CMS issued guidance to labs and other providers on how to use the newly approved Centers for Disease Control and Prevention (CDC) test for coronavirus. Here are the key takeaways. The … [Read more...]
CLIA: CMS Revises State Operations Manual for Labs
January 2, 2020
In late September, the Centers for Medicare and Medicaid Services (CMS) released QSO-19-20-CLIA: Revisions to State Operations Manual (SOM), Chapter 6—Special Procedures for Laboratories. The release, … [Read more...]
CMS
CLIA: CMS Proposes 20% Fee Increase—and Further Increases Could Follow
January 28, 2019
As if Year 2 of PAMA lab fees wasn't enough, CMS dished out another dose of agita to the lab industry: CLIA fees will be going up 20%, effective this year. Background For those of you who are new to … [Read more...]
FOCUS ON
CLIA: After 36 Years, CMS Gives Lab Accreditation a Good Hard Look
January 16, 2018
"May you live in interesting times." If you've been in the clinical labs business for a while, you probably appreciate the wisdom behind this ancient Chinese curse. 2018 is shaping up to be a very … [Read more...]
REIMBURSEMENT
Medicare Reimbursement: CMS Finalizes Controversial PAMA Fee Schedule
December 12, 2017
It's official. CMS is going forward with its controversial 2018 PAMA Clinical Laboratory Fee Schedule (CLFS). Regrettably, the final version closely tracks the preliminary one (See GCA, Oct. 24, 2017, … [Read more...]
PRODUCT DEVELOPMENT
FDA Watch: Agency to Allow DTC Marketing of Genetic Tests without Premarket Approval
December 11, 2017
The FDA's longstanding policy of restricting direct-to-consumer (DTC) marketing of products without formal premarket approval is well known. But while it always applied to lab tests, the policy … [Read more...]
ENFORCEMENT
FDA Watch: Agency Moves to Boost CLIA Waiver Transparency
November 13, 2017
The CLIA standards that a lab must meet are based on the complexity of the in vitro diagnostic tests it performs. The FDA's primary role in the CLIA system is to categorize IVDs. Test … [Read more...]
ENFORCEMENT
Theranos Announces Settlement Agreements with CMS and Arizona Attorney General
April 26, 2017
After facing federal and state government scrutiny for more than a year, Theranos has reached agreements with the Centers for Medicare & Medicaid Services (CMS) and the Arizona Attorney General to … [Read more...]
