LDTs

Laboratory Developed Tests: The VALID Act is Back

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

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

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

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

"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

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

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

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

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...]

ENFORCEMENT

Theranos Settles with CMS and Arizona Attorney General

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...]


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