Scorecard: SVT False Billing Settlements Near the $3 Million Mark

Urine drug testing for purposes of medical treatment is deemed medically necessary under Medicare billing and payment rules. The same is not true for specimen validity tests (SVT), a quality control … [Read more...]


Two commercial labs testing now for COVID-19

Two commercial lab companies have announced they are moving into testing for COVID-19. LabCorp. said Thursday it was immediately offering testing for COVID-19 and Quest Diagnostics has announced it … [Read more...]


FDA Watch: Agency Finalizes CLIA Waiver Guidance for New IV Devices

On Feb. 25, the FDA issued a pair of final guidances to help manufacturers seeking clearance for new in vitro diagnostic devices. Here are the highlights. CLIA Waivers The first guidance … [Read more...]

Diagnostic Deals

Inside the Lab Industry: Reimbursement Cuts & Payor Denials Belie Industry’s Steady Growth 

The worldwide market for clinical laboratory services has grown 2.9% per year since 2010 with an estimated value of $121.5 billion in 2019. And over the next five years that growth is expected to … [Read more...]

Emerging Tests: Lab Industry Mobilizes to Develop Coronavirus Detection Test

The global coronavirus (COVID-19) outbreak came without warning and is having a seismic impact on laboratories and the diagnostics business. The imperative for the industry right now is to develop a … [Read more...]


Diagnostic Deals: Urgent Need for Coronavirus Diagnostics Fuels Strategic Collaboration

Not surprisingly, teaming up for development and commercialization of coronavirus (COVID-19) detection and vaccination products was a major theme of strategic alliance making during the period. … [Read more...]

CMS Increases 2020 Maximum Civil Monetary Penalties

Every year, HHS adjusts for inflation the maximum civil monetary penalty (CMP) amounts that a lab or other provider can be fined. In 2020, CMP maximums will increase by 2.522%. The new higher CMP … [Read more...]


FDA Watch: Agency to Use EUA Pathway to Clear New Coronavirus Detection Tests

There are no FDA-cleared tests to detect the new 2019-nCoV Wuhan coronavirus. But on Jan. 28, the agency unveiled its strategy to promote the rapid development and availability of safe and effective … [Read more...]


Diagnostic Deals: Lab Corp & Quest to Continue Targeting Small and Independent Labs for Acquisition

PAMA price cuts were supposed to drive consolidation in the lab market. The expectation was that price pressures would make it impossible for smaller labs to remain independent, rendering them juicy … [Read more...]

Labs In Court

Lab Management Contract Dispute Must Go to Binding Arbitration

Case: A lab management services contract sent conflicting messages: Clause 32 said that all disputes under the contract would be resolved by binding arbitration; but Clause 7 said that all claims … [Read more...]