Paying physicians fees to collect and process patient samples for testing is a dicey proposition because it exposes labs to suspicion under the Stark and Anti-Kickback Statute laws. Such arrangements … [Read more...]
Whistleblowers
California Case Shows Why Paying Specimen Collection Fees of Any Amount Are a Liability Risk
September 17, 2020
Technology
CMS Proposes Clarified Medicare Coverage “Reasonable and Necessary” Criteria for Breakthrough Devices
September 17, 2020
On Sept. 1, CMS proposed a new rule that would, among other things, shed some light on an issue that has been a perennial compliance and reimbursement stumbling block for developers of new lab tests: … [Read more...]
EUA
FDA to Issue Emergency Use Authorization for Multi-Analyte Respiratory Panels During the Pandemic
September 17, 2020
The convergence of flu season with the global COVID-19 pandemic will create the need for new multi-analyte respiratory panel tests that are capable of not only detection of but also differentiation … [Read more...]
PANDEMIC
Hospitals, Labs, LTCs Face Big Fines for Failing to Meet New CMS COVID-19 Test Daily Reporting Rules
September 17, 2020
Nursing and other long-term care (LTC) facilities have been a hotspot for COVID-19 infection since the public health emergency began. On Aug. 27, CMS issued a new Interim rule requiring LTC facilities … [Read more...]
LDTs
FDA Breaks New Ground by Authorizing SARS-CoV-2 Tests for Sample Pooling
September 8, 2020
It’s not uncommon for the FDA to revise the Emergency Use Authorization (EUA) for a particular diagnostics test to permit a new clinical use. In most cases, these expansions don’t even get an official … [Read more...]
